Some of the country's top surgeons perform high-stakes surgery. This episode follows surgeons and patients through three clinical trials at the vanguard of medicine.
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Every year some three million major operations are carried out in the UK.
The theatre doors are just here.
But few of us will know what really happens once we're put to sleep.
All right, all you've got to do now is think beautiful thoughts.
I don't think that patient can even comprehend what you're doing in theatre to them.
And that's what the plan is, that they don't know what they've been through.
This series goes behind the theatre doors at the Queen Elizabeth Hospital in Birmingham...
-Let's get cracking then.
..where for the first time, cameras have been allowed to join some of
Britain's top surgeons during their most high-stakes operations.
-Shall we go for it?
-We'll go for it.
Using new technology and pioneering skills,
they are treating conditions that used to kill.
We continue to push the boundaries,
continue to take the inoperable and make it operable.
This is surgery at its most experimental.
This is where I've got to get it right.
People didn't attempt this surgery a few years ago,
because it was just perceived as being too big,
too difficult and too scary.
But pushing the human body to its limits comes with great risk...
Keep it together, keep it together, keep it together.
..for the patients and the surgeons.
An operation will go wrong for a 30-second lapse of concentration.
It needs to work, because if it doesn't I'm going to cry.
Things worry you. You get very worried.
This is going completely the wrong direction.
The trick is to not appear to be worried.
They need to be top of their game every time.
People often characterise surgeons as bombastic and arrogant.
Babcock, please, long one, to me. Slap it in, sweetheart.
You've got to be dedicated to do it, you've got to love it.
Oh, my God! Jesus Christ.
You're only as good as your last result.
This is what it takes to operate at the cutting-edge of medicine.
You have to be jolly careful that you don't bugger it up.
It's do or die, really.
The Queen Elizabeth Hospital in Birmingham
is one of the nation's largest surgical units.
Today, there will be more than 120 operations in its 42 theatres.
So, we are doing a left-hand nerve exploration,
Most are well-established procedures,
but some are clinical trials in which surgeons will use cutting-edge
techniques on humans for the very first time.
If we go through the waiting list,
at the moment we have got six active patients.
Surgeon Richard Laing is working on a trial targeting
one of the nation's biggest health crises - liver disease.
Because of a Western diet,
obesity is a huge problem, and is
one of the biggest increasing causes of liver disease.
Deaths from liver disease have soared by 40% in a decade.
And more and more patients are waiting for life-saving liver transplants.
-'OK, you're on four blues, on your way, four blues it is.'
OK. Thank you.
Today a donor liver is being rushed from London to the team in Birmingham.
This is where it will ask us to put in the data,
so that takes about ten minutes.
Surgeons will only use a liver that they believe is good enough quality
to safely transplant,
and so a number of livers every year are not used
because they're considered too high risk.
Each year, around 400 livers are judged unfit for use,
leaving patients on the waiting list.
Richard hopes to prove that many of the rejected livers are, in fact,
viable for transplant.
This trial has the potential to help so many patients on the list,
but it's a high-risk trial.
I mean, transplantation is risky as it is.
But to take livers that have been rejected by everybody
and to try and put them into patients,
it is nerve-racking.
The liver en route to Birmingham would normally be rejected,
as it has come from a middle-aged donor who died of a heart attack
away from hospital.
And all the time that it's not connected to a live human
body, the liver is deteriorating.
The clock is ticking and time is absolutely critical.
The liver is being starved of oxygen,
and for every minute that passes,
liver cells are dying, and the risks
of that liver not working, following transplantation, increase.
Arrow to arrow, it's colour-coded.
Nice and simple for surgeons like myself.
When it arrives, the donor liver will be connected to a machine at
the heart of the trial.
Through a process called perfusion,
it will restore the liver to its best possible functioning state,
giving the team a chance to assess whether it is healthy enough for a
This machine tries to mimic the conditions that a liver would
experience inside the human body.
So, you give it blood, oxygen, nutrients,
all at the body's normal temperature.
When you give it those conditions, the liver starts to function.
And not only does it function, but there is also a degree of
reconditioning and the liver gets the opportunity
to start to repair itself.
And what this machine allows us to do is to take a liver that's deemed
unsuitable, and prove in fact that it will function
after it's transplanted.
If all goes well, the donor liver will be transplanted to Connie O'Driscoll.
Connie's lived in the UK for more than 30 years,
almost as long as she's been suffering from a rare liver condition.
This is like round three for me at the Queen Elizabeth.
First was a bleed-out that brought me here for emergency rescue surgery.
When that was finished they found I had liver cancer
and they saved me again.
Now it's time for a new liver, because the old one has
pretty much taken a beating.
The last two years there has been nothing but medical, medical, medical, medical.
It has just absolutely consumed my life.
For Connie, the chance to get a transplant quickly is outweighing
any nerves about receiving experimental treatment.
We are recruiting 6,500 plus new patients into trials per year.
Some of those are ground-breaking trials, and will potentially change
the way in which care is delivered.
Hilary Fanning is in charge of all clinical trial activity within the trust.
Trials are about bringing the possibility of better treatment
and, in some cases, hope to patients who may not otherwise
have hope, because of their particular condition.
Today's research is tomorrow's standard of care,
so undertaking clinical trials is a fundamental part
of the delivery of a high-quality clinical service in the NHS.
-'Hello, it's Claire.'
-'Just to let you know, your ten-minute warning has gone in.'
-OK, thank you.
The donor liver will soon arrive for the first stage of the trial.
So, we'll go and set up the medications.
There is an air of anticipation -
"Is it going to work, is it not going to work?"
"I think this one'll work." "This one's never going to work."
Then the liver arrives.
And we get the first sight. And it might look really good,
it might look really awful.
You know, there are some livers which we'll put on the machine that
just don't function.
So, is a bit fattier than we thought, isn't it?
It's not the best-looking liver.
There are features that would mean that you wouldn't necessarily want
to transplant this liver straightaway.
But this is what the trial is for.
We've just been putting all the cannulas in so we can connect it to
the device, and then over the course of the perfusion we'll start to see
various readouts that will indicate whether or not the
Richard needs to run a series of tests to find out if it's healthy enough to transplant.
The liver has four hours to prove itself.
The liver might not function at all.
Only time will tell.
As well as being risky, clinical trials are expensive.
Along with the funding comes intense scrutiny.
In terms of income associated with awarded grants,
can you remember where we are with that?
25 million across Birmingham Health Partnership.
Was that last financial year?
I think it does take a particular type of person
to undertake clinical trials.
They have to be really sure that what it is that they're trying to
achieve is the right thing, and they have to maintain their belief in
themselves and their ability to deliver that.
There is a huge amount
of professional satisfaction in being a pioneer.
That in itself pushes you to the point of accepting a degree of risk
associated with clinical trials.
As a surgeon you are really sticking your head above the parapet.
If you're involved in trials like this, most people know you're doing it.
It's hard to keep these things quiet.
And if it doesn't work, you're still going to have to face them.
But you take that chance.
Consultant surgeon Richard Irving
and Professor Philip Begg
have received over £1 million to fund their trial.
They hope it could one day help to transform the lives of thousands of
people in the UK who have profound hearing loss.
So, in relation to the access to Paul's middle ear,
the pinna will be rotated out of the way and that's all going to be out
of the operative field.
The team are trailing a world first.
They're going to surgically implant this tiny hearing aid microphone
inside the patient's skull.
Their goal is for it to be more discreet than today's external hearing aids
and, perhaps, improve on their sound quality.
The impetus behind this really comes from patients.
They get a huge amount of benefit from an external hearing aid,
but still there are some lifestyle restrictions that they have.
And they're wearing something on their ear and on the outside of
their head, so it's visible.
For many patients that is a big downside.
People don't like looking different.
At night typically, patients, they take their device off
and they go back into a world of silence.
They can't hear, for example, a smoke alarm, a baby crying,
and they would feel really cut off.
63-year-old caretaker Paul Heaney started to lose his hearing more
than 20 years ago. He currently wears a cochlear implant
with an external sound processor microphone behind his ear.
He will be one of the first six people to trial the new internal microphone.
When your hearing goes, you feel a bit isolated in society.
People sort of tend to avoid you in certain situations rather than
having to repeat themselves.
You feel a little bit left out.
Paul is almost totally deaf, because of deterioration in his inner ear.
Although the trial is focused on testing whether the new microphone
is safe, he hopes it will lead on to the invention of completely internal
Eventually when it's finished,
we'll get rid of all the outside paraphernalia and just be straight
through the ear.
It's a little bit of a step in the dark for me at the moment,
but from what I've read up about it
it would definitely be an improvement to the current status.
With Paul, that's an incredible thing to ask someone,
a huge thing to ask someone,
to agree to undergo an operation that they don't have to have.
He has a genuine desire to help other people.
If this is successful, then he will be down as one of the patients
who helped with this revolution.
Paul's procedure will take place in Theatre 15.
Richard will perform the pioneering surgery while Philip and an audio
research team will test the new implant.
-What are we doing for Mr Heaney?
Working on his left ear,
placing a middle ear microphone and a pedestal through the skin.
-OK, blood lost?
-Duration of surgery?
Yeah, any specific equipment you need?
-Lots and it's all here.
-OK, microscope on, thanks.
I'll just give this a clean.
Richard will have to insert a hearing aid microphone smaller than
a matchstick right inside Paul's head.
And then connect it to the tiny bones in his middle ear.
To implant the device he'll need to drill out a minute channel
through solid bone,
navigating between two important nerves.
One that controls facial movement,
and another connected to the sense of taste.
It is a surgical challenge to work in that area of the body.
So, you have to be incredibly careful.
OK, if you've got the razor...
I need to take this to the table, Richard, at some point.
Yeah, let me just clean out his ear and then I'll put the probe in.
Richard is one of the most talented surgeons I've ever met.
Suction can be on, please.
We've got a very unique relationship.
We are two people who you might expect to have quite big egos.
We kind of leave our egos at the door.
And we work really, really well together.
It is a relationship that's based on respect.
-It is ready to go in, yeah.
So, this probe goes in the external ear.
Before Richard begins, he tapes a small speaker inside Paul's ear.
This will play test sounds, so the microphone can be checked by sound
engineer Rob Morse once it's implanted.
So, we are putting a sound into the ear to make sure that's our levels right.
-Happy? Let's start, yeah.
Just going to start the incision
working my way through the
scalp and the soft tissues.
I'll just get enough exposure and then I'll start.
Make my access route through the skull.
OK, right, great, let's have the drill, thanks.
So, I now make a passageway through the bone, working
in an area behind the ear canal.
First Richard has to drill a channel into Paul's skull,
less than a centimetre from the membrane that protects his brain.
When you first do this, you're incredibly nervous.
You're incredibly slow.
There is a risk that the membranes could be breached,
and of infection that could spread inside the skull.
These are incredibly rare, but they're things
that go through your mind.
Can I have the microscope, as well? Thanks.
I often compare it to how NASA prepares astronauts,
where they'll spend maybe 20 years preparing for a flight
that takes ten, 20, 30 days.
And it's the same with this, with the surgery.
We spent a year planning for every possible disaster that could happen.
Have you got a one cutter, thanks?
-And a smaller sucker.
As you become more and more comfortable,
somehow you're able to switch off in this surreal world.
I am conductor of that orchestra while I'm operating,
and I determine what is happening in that environment.
I have now got a much smaller tip and I'm making a small passageway
into the back of the middle ear,
running between the facial nerve,
that's the nerve that moves the face
and the nerve that supplies taste.
Two structures that I would very much like to avoid.
We are doing a surgical procedure on what is arguably one of the most
delicate parts of the human body
in the skull.
So, within a tiny area, a couple of centimetres across,
I have all of those anatomical structures to deal with,
and what I am doing is taking a high-speed drill
and making my way through.
Clearly if things do not go to plan,
that could have a huge impact on that patient's quality of life.
In Theatre 5, Richard Laing has been monitoring a donor liver
he wants to use in the transplant trial for the last two hours.
The organ's being kept alive by the perfusion machine,
supplying it with blood, nutrients and oxygen.
I'm going to take a biopsy in here.
Only specific tests will determine if the liver is now good enough for
We'll look for various readouts that will indicate whether or not the liver is functioning.
It shouldn't be too much longer before we can make a decision on
whether or not it's transplantable.
One of the liver's main jobs is to turn lactate,
an acid produced by muscular activity, into glucose.
A lactate reading of 2.5 or lower
indicates the liver is functioning well enough for transplant.
The liver is very close to coming into criteria.
We're just waiting on this last result.
Before the lactate was 2.6.
It's now down to 2.1.
Textbook liver function.
The liver's met the criteria, which is fantastic,
but this is just the start.
The question now is will that liver continue to function
after it's transplanted?
Hello, Mrs O'Driscoll, how are you?
Nice to see you. Lovely to see you again.
I didn't think we'd be seeing each other so soon.
I know, it has been soon, hasn't it?
Good thing I had my suitcase packed.
This liver was offered to us yesterday.
We were able to put it on the machine.
-And it performed very well.
Mr Perera doesn't see any reason why we shouldn't use the
liver. He will be making his way...
-Is he the surgeon?
-He's the surgeon who will be doing the operation.
Very, very experienced.
-You're in safe hands.
I feel in safe hands.
-OK, well, it's good to see you again, OK?
-And we'll see you soon.
By signing up for the trial,
Connie will get the transplant she needs fast.
But everyone is conscious of the price she could pay.
With any clinical trial, there is a degree of risk.
But the stakes are huge with this trial.
If we can't do what we're setting out to do,
which is show whether or not a liver's going to function after it's
transplanted, for us as clinicians it's really disappointing.
But for the patients, that could be devastating.
Worst case scenario, they can die.
In theatre, Connie's life will be in the hands of transplant surgeon
In the last seven years he's performed hundreds of transplants.
Transplant surgery, it's not a very popular field,
because it has quite a lot of hard work that you need to put in,
but someone has to do it.
There are so many patients out there
waiting on the transplant waiting list, so you don't want to stop.
You just need to keep going.
I can see the transformation, which I like, you know?
You really feel that you have done something to the patient and the
patient has got a new life.
That is what makes this job worthwhile.
There comes a point where you've done every bit of planning,
every bit of preparation...
You've just got to take that leap of faith and go to the next stage,
and just hope that it works.
Patient's name and procedure.
We've got Connie O'Driscoll on the table for liver transplant.
OK, expected blood loss.
Unpredictable, could be loads depending on the situation.
Thamara is a machine.
He is so dedicated to becoming the best in the world,
I've no doubt about it. He's so driven.
He fights for every single patient, to get them a transplant.
If I needed a liver transplant, Thamara would be definitely at that table.
Can I get the temperature down on theatres, please?
The main surgical challenge is to connect Connie's new liver
as quickly as possible.
First, Thamara must carefully divide and detach the major arteries and
veins connected to Connie's diseased liver.
These need to be securely clamped so Connie doesn't bleed out.
He'll then have to work fast to put the donor liver in position and
connect it to Connie's blood vessels and bile duct.
The time is critical,
because each and every second where the liver is out of the machine,
it undergoes a degree of damage,
which could lead to failure and emergency re-transplant.
In Theatre 15, Richard Irving and Philip Begg
are two-and-a-half hours into surgery to plant a new
kind of hearing aid microphone inside their patient's skull.
So far Richard has managed to work around Paul's delicate facial nerves
as he drills towards the middle ear.
Now he needs to drill even deeper to reach the tiniest bones in the body,
which transmit sound to the inner ear.
Slower, more careful progress in this area.
Exposing the bits of the middle ear that I want to get access to.
The ambition is for this new technology
to improve on the broad range of sound
that gets picked up by external microphones.
Instead, it is designed to produce
much more directional sound, by
picking up the vibrations from the tiny incus bone in the middle ear.
So, straight ahead of me is the incus bone,
and this is where we are going to attach our microphone.
Next Richard has to drill a hole into the fragile incus
which is scarcely three millimetres wide.
There is not a large number of us that do this,
and it does require fine dexterity
and a lot of confidence in what you're doing.
It takes time, it takes expertise,
so the skill that Richard demonstrates in bucketfuls
gives us a safe place to implant.
OK, that looks a nice depth.
Thanks. So there is the little hole on the incus bone.
OK, have you just got the fixation piece there for me?
Needle to me, please.
What I want is that hole in my incus
to be pretty much in the centre of that disc.
Which is there.
Which it is. That looks pretty good, doesn't it, yeah.
So I can fixate here, yes?
-Shall we get the implant?
Richard now has to insert the tip of the microphone
into the tiny hole he's drilled in the incus.
It has to be implanted with just the right amount of pressure.
Too much, or too little, and the microphone won't work.
The recess is 0.6 of a millimetre across
and about a millimetre deep.
That is the key challenge as to whether this thing works -
can you get this coupled precisely to the bones of hearing?
-I'll straighten this.
-Yes, it can be straight.
I have to try and gauge really, just using the senses in my hand the
tension between that bone and the microphone.
We really do not want anything to go wrong.
Yeah. Good job.
Green screen over, thanks.
OK. Shall we connect up, yeah?
The implant is in place.
Now Phil and the audio team need to play sounds through the speaker in
Paul's ear, to check the microphone picks them up.
You should start hearing it now.
Just trying advancing it slightly.
See if that's any better.
No, it's still low.
You're not picking up any sound in theatre either.
Yeah, it's too quiet.
Unless they can get the implanted microphone working,
the operation won't have any benefit for Paul.
This has developed over a number of years.
The responsibility for it does sit on my shoulders as the chief
investigator. That's something I have to manage and is something
that I am accountable for.
Clinical trials wouldn't be possible if there weren't the patients who
were brave enough to take part,
and put their own health on the line in a lot of cases,
and their lives on the line.
We have a duty to really look after these patients as much as possible,
and make it as safe as possible and really try and get them through it.
In the transplant trial in Theatre 3,
Thamara Perera is about to remove Connie's diseased liver, and replace
it with a donor organ that's been revived and rehabilitated.
We'll have to start, thank you.
The surgery itself is extremely complicated,
and you have an organ that is diseased,
but also is receiving two litres of blood a minute,
and you have to be able to get that liver out quickly,
and you have to be able to put the new one in.
Using an electrosurgical pencil, Thamara needs to carefully separate
Connie's liver from the surrounding tissue in her abdomen.
As surgical lead, he must stay aware of everything that happens in theatre.
There are three zones in a surgeon's focus.
The immediate focus is there,
the structures, what I'm going to do.
At the same time I have a peripheral focus,
the team are on me, what are they doing?
Is the scrub nurse ready with the next instrument?
The third zone, it's the environment,
the theatre environment.
Are you OK?
Without the three zones, you cannot perform a good operation.
Left hepatic artery is going.
The liver is attached to major blood vessels,
including the arteries supplying blood from the heart and the portal
vein which carries blood to the liver from the stomach and intestines.
These all need to be disconnected with immense care.
They will need to be used again, when attaching the donor liver.
There are two sources of blood supply into the liver,
these are the portal vein and the hepatic artery.
But this is not for people who are chicken-hearted.
This lay is a bit...awkward, isn't it?
Until Connie's vessels get joined up to the new liver,
they need to be clamped to prevent dangerous blood loss.
If you don't get it right, the bad outcomes happen
in front of your eyes.
Yeah, fine, I'll be ready.
Thamara is close to removing Connie's liver,
so it's time to get the donor organ ready.
John, are you OK for me to take the portal vein?
Portal vein is clamped.
It's going to be flushed in a second.
Disconnect the liver, we are ready.
Disconnect the liver, right, OK.
We'll work our way through taking it off now.
Connie's liver has been removed.
And with the donor organ coming off the machine's
oxygen and blood supply, the team must move fast.
The timing is important,
because I do not want too much time spent
between it coming out the machine and reconnection of blood supply.
It has to be 20 minutes.
-And then it is connected.
-It will be two minutes, OK?
Once that liver is removed from the machine, the clock is ticking.
It is deteriorating, the cells are dying.
Now the donor liver is in Theatre 3,
Thamara has just 13 minutes to connect it to Connie's blood vessels.
He will start with the large portal vein,
which delivers 75% of the liver's blood supply.
Clamp on the cable, please.
It is one of the most complex operations.
There has to be a mental design in your head.
How am I going to put these two structures together?
You need to know what I am going to do now,
my next suture is going to be there.
Add the following suture is going to be there.
Hold this, please. With my hand, please.
OK, that's finished.
Cut the bottom two needles, please.
Big spoon clamp, please. Pick-ups to me.
Starting the portal vein.
The portal vein is a thin, fine structure,
susceptible to tear during the operation.
The integrity of these vessels are important for the survival
of the liver.
You cannot take hours and hours doing these two joints.
Do you see what I am doing?
Holding the cut edge and stretching it.
Imagine a line parallel to that edge.
Scissors ready, please.
Turn one minute.
It is an enormous responsibility to operate on a patient,
so you need to have courage and you need to have expertise.
Portal vein is finished. Hold this, please.
You need to take the clamps off,
let the blood flow through the liver into the patient.
With blood now flowing through the donor organ,
Connie's body could have an adverse reaction to such a major procedure.
This is the period the patient can become really unstable.
Sometimes the changes are powerful enough to stop the heart.
OK, that clamp's off.
In Theatre 15,
the hearing aid trial team have been working for five hours.
But the operation has been at a standstill for the last 45 minutes.
Are we getting something?
It is not good, though.
The miniature microphone implanted in Paul's middle ear still isn't
picking up any sound.
We can't really proceed with that.
It is one of those episodes in your surgical career
where you emotionally go from somewhere up here
to the bottom, and instantly you think,
"I've done something wrong. What have I done?"
OK, well, we will have a look at that and see.
-I think so.
I think you're right.
I think it's the mic.
If the microphone HAS been damaged,
they will need to extract it and repeat the operation with a new one.
No real change. I have done all of the surgical sounds
-and your voice and all of that.
-There was nothing?
There was nothing. No.
We are checking the channels as well, just in case.
Doing a surgical procedure that has never been done before,
it doesn't always go to plan.
And sometimes you can't explain why it doesn't go to plan.
That is part of the life as a surgeon.
But you take that risk.
Before unscrewing, can we just check that probe first?
Next they decide to check if there is any fault with the speaker they
are using for the test.
It is taped inside Paul's ear.
Is that better now?
Oh, my God!
I can hear everyone.
-The probe slipped off.
That is... I can hear myself...
That is perfect.
The speaker had come loose, so no sound was reaching the microphone.
There is always a solution.
It is about working the problem,
using the Apollo 13 mission statement,
"Failure is not an option."
It is just, you know, your seven o'clock beer becomes a nine
o'clock beer. That's the only difference in life.
OK, anything else we need to do, or can I close up?
-Time to close, yeah?
Table up in the air a little bit, please.
-If this is successful, it will be hugely satisfying.
To think that a significant advance in science has been attributed to
something that you have actually done, and that is huge.
OK. Everything is nearly finished.
Just putting a dressing on your head.
-Should be good, shouldn't it, really, with those results?
Although the microphone is functioning,
the team will not know whether it is helping Paul until he has recovered
from surgery, and it gets switched on for testing.
If we are successful, it is a game changer,
and potentially will be life-changing for tens of thousands
of people across the globe.
Throughout the hospital,
tools and treatments that have emerged from clinical trials are
revolutionising everyday health care.
Now, then, how is your elbow?
I think it looks good.
Lieutenant Colonel Professor Steven Jeffery is a consultant plastic
surgeon who specialises in treating burns.
Many burns patients like David Walsh struggle with recurring wound
-The flap's fine.
Yeah, that looks very good, but...
Having a large number of bacteria present in your wound
is not good for your wound,
so that tells you you have got to do something about it.
Steven is using a new device that has recently been through successful
It detects bacteria much faster than traditional methods.
Previously, if you suspected a lot of bacteria to be present and maybe
infection, you would take a swab, microbiology swab,
and you'd send that off to the lab and you'd wait three or four days
and you'd get the result back.
We will take a look using this camera, the MolecuLight camera.
-What it does is, it shows you bacteria.
OK, so we are going to have to darken in the room
for this to work.
Illuminating the skin with a specific wavelength of light
makes bacteria fluoresce under the MolecuLight screen.
Most bacteria will shine red.
There's another type of molecule which will fluoresce
a kind of greeny blue, and that's found in pseudomonas,
which is something that is particularly troubling to us in the
You see that there, the lightened bits? Are they the infected bits?
-Yeah, they are.
-I knew it, I bloody knew it.
With faster, more accurate diagnosis, treatment can be more effective.
You have got pseudomonas in that...
But it is OK, now we know what it is, we can treat it.
I don't think the inventor had fully appreciated how big this was
going to be, and how important it is to see bacteria in real time.
That has never been possible before.
Trials targeting Britain's most widespread and deadly health problems have
the potential to save thousands of lives.
Urology surgeon Prashant Patel is looking for new ways of tackling a
disease that will strike one in eight men in their lifetime -
Cancer in the UK at the moment is an epidemic.
Prostate cancer is now the most leading cause of cancer diagnosis
in UK men.
10,000 patients are also dying from prostate cancer every year.
Prashant's team are working with the University of Birmingham to trial an
ambitious technique that could supersede today's treatment options.
Chemotherapy and radiotherapy, whilst effective,
it causes a significant amount of collateral damage.
The idea of doing the trial is to go for the punching -
see whether we can cure and control the cancer,
but at the same time minimise the side-effects.
The trial will involve injecting a patient with a genetically modified
virus, triggering a process which should attack and destroy the cancer
cells. Only 11 patients have signed up to try it out so far.
79-year-old William Yates is a grandfather of five.
He will be Prashant's 12th subject.
-Good morning, Mr Yates.
-How are you?
-I am very good.
-Yes, thank you.
You have met Sian and Fiona already.
-Yes. I have met the Angels.
-Excellent. So you know what is happening today?
-So we are going ahead with the prostate cancer gene therapy trial.
The stakes for conducting any particular clinical trial
are extremely high.
All things we do in medicine is associated with risks.
And there are known risks and there are the unknowns.
When it comes to clinical trials,
it is the unknowns which we are trying to explore.
But that is the way medicine evolves.
And just to recap, we are doing this
because you have had prostate cancer diagnosis,
a few years ago you had radiotherapy
-and now there is some biochemical failure.
William is taking part in this trial as his prostate cancer has returned
after eight years in remission.
He is keen to get involved with testing the innovative treatment,
despite its lack of a proven track record.
-So we have got this opportunity to treat you with gene therapy.
I was quite proud to be a guinea pig, to be quite honest.
And if that can wipe it out in years to come, I think
I have done my little bit, so I am quite happy about that.
-Are we ready to rock and roll?
Right, we will get you changed and I will be seeing you in theatre in a
-OK? Right. We shall see you in a bit.
OK, good morning, all. William Yates, gene therapy trial.
So everyone's eyes should be covered.
This is a risky trial, because it is the first time
this kind of genetically modified virus has been used on humans.
All experimental treatments must be proven safe before they can progress
to wider trials.
We are the only people who are conducting these trials.
We are dealing with biologically modified viruses.
They do not normally exist.
Here is our gene therapy pharmacist.
We have got all six syringes ready.
We hope that when this virus enters into the body, it will attack
the cancer cells,
and in addition will also provoke the immunity of the patient to fight
against the cancer without causing significant side-effects.
The treatment has two stages.
First, the genetically modified sample of the common cold virus will
be injected directly into the prostate.
The virus is altered so it won't spread,
and so it changes the biochemistry of the cancer cells.
Next, after 48 hours, a drug is given to the patient.
When this drug comes into contact with the cancer cells affected by
the virus, it will start to kill them off.
We have got the ultrasound scan set up of the prostate,
and the grid is on there, as you can see.
Prash needs to inject the live virus with great precision
into the six cancer sites in William's prostate,
showing up as the darker areas on the ultrasound.
To keep William comfortable and completely still,
he is under general anaesthetic.
There are risks associated with these kind of trials.
With live biological agents like viruses,
we keep a very close eye on the patient's side-effects.
Ready when you are.
The worst-case scenario is virus related inflammatory reaction.
It just doesn't give you a flu-like illness but a very severe
inflammatory illness. In that case we are in problem.
But as with all trials like this, they won't know how William's body
will react until he has received the virus injections.
Right, OK, we are ready to start.
In Theatre 3, the transplant trial team have rushed to get Connie's
new liver into position, and started connecting it to her blood supply.
Now surgeon Thamara Perera is moving on to the most delicate stage -
plumbing in the network of hepatic arteries which help to supply the
liver with oxygenated blood.
In those very fine sutures, you need to slow down, focus.
You need to make it the best possible way so that it will not
make any clots or damage into the blood vessel.
If a clot develops in the hepatic artery, that is going to
damage the liver.
Can I get this artery...
If you rupture a blood vessel,
the amount of bleeding is enough to kill a patient within 30 seconds.
One of the arteries is proving difficult.
One of my teachers told me, when I first became a surgeon,
he said, "God has given you power. It is a privilege.
"Please make sure every patient goes home safe."
With all the blood vessels attached, Thamara has got one last task -
reconnecting the bile duct which supplies the digestive system with
the fluid we need to digest fats.
That looks all right.
-We are happy to close, then?
-Looking very great.
Once you know everything has gone OK, it is a big relief,
so that is probably the time to take a proper deep breath.
OK. Thank you. Thank you, everybody. Thank you. Thank you.
Could we have staples, please?
Calmly and nicely.
The operation is complete in time.
Lactate on the machine was 1.2, glucose was...
Now they must wait to see if Connie's new liver continues to perform.
The liver's functioned as we would have hoped.
But, you know, this is a trial.
Connie has got a long road ahead of her.
And there are no certainties.
We will just keep our fingers crossed that she does well.
In Theatre 28, prostate cancer patient William Yates
is about to be injected with a genetically modified virus.
As you can see, whilst I am moving the needle, it is in that area.
For neurologist Prash to test his new gene therapy technique,
he needs to deliver it to the site of the cancer
with pinpoint accuracy.
Prior to the procedure,
we would have done all our prior mapping of the prostate,
as to where the cancer is.
But we use the grid to accurately place the virus within the cancer.
OK, now, as soon as the virus goes in,
you can see there, you see?
You've got a very nice distribution.
Second injection going in.
And the co-ordinate for this is...
-That will be going at the same depth?
-Same depth, five.
Yeah, that is perfect placement there.
So it is e3, please.
OK, I am happy with that.
As soon as the virus goes in, I have got a very good coverage.
How is he behaving on the top end?
OK. The right side is all done.
As you can see, it is all blanched out white.
OK. Injections are done.
Everything gone on schedule, which is good.
Exactly as planned.
OK. Over and out.
During the next few hours, the virus should start to trigger
changes in the cancer cells in William's prostate.
So this is your infusion.
This will work with the treatment that you had.
-Is that the killer?
-Yeah, this one...
-This is the...
It is? Oh, good.
The drug William is getting will only become a tumour killer when it
reaches any cancer cells affected by the virus.
Unlike chemotherapy, it won't damage the healthy cells in his body.
-And how long does this one take?
-Five minutes? Is that all?
So it is a battlefield inside my body now, then?
If this works, I shall feel marvellous.
And if it helps to help other people,
then at least I have done something useful in my life.
OK, that one is all done.
It is often the case with medical trials we have to wait and watch,
and in William's case that will be very much applicable.
We just keep our fingers crossed, hold the nerve,
and see whether he has withstood treatment without any significant
And from William's perspective,
whether the treatment has had any effect on his cancer.
For every successful clinical trial,
there are countless others that end in failure, or doubt.
And with a failed trial, it is not just the clinicians who are affected.
It just might not work,
and we would all be very disappointed after all this effort.
Particularly the patient.
They would be hugely disappointed if they have gone through this
and it doesn't work.
Paul is about to find out if the implanted microphone has helped his hearing.
Having recovered from the operation,
today he is having it switched on for the first time.
OK, so I just need to make a few changes on your existing processor.
He is still wearing his old external microphone.
But now they are going to switch that off and turn on the new implanted microphone instead.
-I will start speaking to you, Paul...
You are listening to me now through the middle ear microphone.
-So how does my voice sound compared to your normal microphone?
-Excellent. That's great.
I haven't heard with this much clarity for the last 20 years.
The general background noise is completely gone.
Much more volume and more clarity.
You're all set.
It definitely gives me a lot of hope to be a bit more social.
It is a fantastic device.
-Good luck with it, Paul.
-Yes, it has been quite an adventure.
If this really works, and the early evidence is very encouraging,
then in years to come, there could be surgeons all around the world
putting this technology and benefiting tens of thousands of patients.
And that's really the buzz of a project like this.
That, to me, is probably about the most exciting thing you can do
as a surgeon.
-How are you?
-I'm fine, thanks.
It has been two weeks since William received experimental gene
therapy, in the hope it will stop the spread of his prostate cancer.
Right, so have a seat.
He has had no bad reaction to the live virus -
a crucial factor in this initial trial.
Your blood results are available,
so let's have a look at them and see how you are.
Something which you will be very keen to know is the PSA.
PSA is a protein produced by the prostate,
and is used as an indicator
for cancer. A reduction would mean William's treatment is working.
Recently your PSA was on a sharp rise.
-A very steep rise.
And when we did the injection, your PSA has dropped down...
-Your results so far have been quite reassuring.
-I don't think you should open a bottle of champagne as yet.
The most important thing is what the trends are and how it is
-over a course of time.
William will need to return for regular PSA testing over the months ahead.
-Oh, that's lovely to hear, anyway, yeah.
-I will see you in a week's time.
-Any problems give us a bell.
Although William's results are promising, this is just the start.
The current trial is aimed at proving the treatment is safe from dangerous side-effects.
Next, the team will need to run a phase two trial to assess
just how effective it is against the cancer.
It is an extremely long process for something that starts off
from a bench side to enter into clinical practice.
You may not even find that light at the end of the tunnel,
but that doesn't stop me from exploring.
The ultimate goal for Thamara Perera, is to increase the number
of donor livers available for patients who will die without them.
Today he is checking up on Connie after her transplant.
-Good morning, Connie. How are you?
Just what I like to see, those smiley faces.
-How are you feeling?
-I am feeling wonderful,
and excited and ready to go home.
-That is good.
-I couldn't be more happy.
Without that machine, I would not have received this liver.
I'm looking forward to a future.
I think those two words right there, "a future," says it all.
Good. We will see you in the clinic next Monday, then.
Thank you. Thank you, thank you.
Good, you're welcome. See you Monday.
Well, she has done remarkably well, actually.
Perfectly normal liver functions.
She is up and about.
And she is a happy woman today.
It is a privilege to be in this era.
People are excited, transplantation practice is changing.
-Is this my chariot?
Come ten years, transplantation of organs on machines
is probably going to be the gold standard.
Bye, and take care.
I think when you start out doing research,
you can only really hope to be part of something like this.
To see someone who enrols in the trial and receives one of these livers,
and then you see them in the follow-up clinic a month later,
they've changed dramatically.
Feels great to be minutes away from fresh air.
Oh, I'm just, I'm just...
To make a difference to people, it is absolutely a fantastic feeling.
You can't really ask much more than that.
There are now more patients involved in clinical trials in the NHS than
ever before. And like the medical pioneers who came before them,
the surgeons at the Queen Elizabeth will keep daring to attempt
tomorrow's procedures in their theatres today.
Wherever you have expertise, and whatever area you're working in,
you look at what you've got and you think, can we make it any better?
Whether or not it does actually push the envelope, time will tell, but
we're determined and we'll keep pushing it.
The groundbreaking three-part series concludes with the extraordinary stories of clinical trials being carried out at the surgical unit at the Queen Elizabeth Hospital Birmingham.
Surgeons allow the cameras to follow as they venture into uncharted territory, performing new kinds of surgery on human subjects for the very first time. Tracking three clinical trials at the vanguard of medicine, the programme asks what it is like to take part in this kind of experimental treatment, for both surgeons and patients. For all involved, the stakes could not be higher. The surgeons relish the intellectual challenge and the thrill of pushing science forwards - but they know that reputations and self-belief are on the line. For the patients, there is the desire to benefit from potentially lifesaving new techniques and treatments - but also the risk of unpredictable adverse reactions that could even be life-threatening. As one surgeon says, 'Clinical trials wouldn't be possible if there weren't patients who were brave enough to take part and put their health and lives on the line. So we have a duty to make the trial as safe as we can.'
Many clinical trials target the nation's most acute health issues. With deaths from liver disease soaring by 40 per cent in a decade, more and more patients are waiting for vital liver transplants. There is a shortage of organ donors and many donated organs are rejected as only those in excellent condition are considered suitable for a transplant procedure. Surgeons Richard Laing and Thamara Perera are part of a team at QEHB trialling a revolutionary way to tackle this crisis, by maximising the number of donor organs that can be safely re-used.
The film follows the trial every step of the way, as Richard receives a donor liver that would usually be rejected and tries to prove it is viable for transplant by rejuvenating and testing it on a perfusion machine. This machine sustains the liver by mimicking the supply of blood, oxygen and nutrients an organ receives inside a live, healthy human body. Once the donor liver has proved itself fit for transplant, the surgical team start to remove grandmother Connie O'Driscoll's severely diseased liver. Once the donor liver has been disconnected from the perfusion machine, they have just 20 minutes to place it in Connie's body and plumb it into the complex and delicate network of hepatic blood vessels.