RecruitingPhase IIInterventional

Randomised treatment of Acute Pancreatitis with Infliximab: Double-blind, placebo-controlled, multi-centre trial

Acute pancreatitis is a sudden, painful inflammation of the pancreas, an organ that helps digest food. It often leads to emergency hospital stays and can sometimes cause severe complications. Currently, doctors can only offer supportive care because there are no medicines that directly cure the illness or speed up healing. This trial is testing infliximab, an established medicine commonly used for bowel and joint conditions. Scientists believe it might reduce dangerous swelling in the pancreas and other organs. Adults who arrive at participating NHS hospitals with acute pancreatitis are given either a single drip of infliximab or a dummy treatment (placebo) within 36 hours of admission. The research team then monitors their recovery and takes blood samples over 90 days. The goal is to discover if this treatment can reduce pain, protect organs, and shorten hospital stays for future NHS patients.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Liverpool

Enrolment target

290

Start

05 Jun 2019

Estimated completion

30 Nov 2026

Acute pancreatitis

What is this study about?

The pancreas is a small gland located behind the stomach that produces digestive juices and hormones. In acute pancreatitis, this gland suddenly becomes inflamed, causing severe tummy pain, sickness, and fever. While many people recover with fluids and pain relief, the condition can become serious and damage other vital organs like the kidneys or lungs. At present, doctors have no specific medicine to stop the inflammation or speed up recovery.

Infliximab is a well-known drug that has been safely used for years to treat other inflammatory conditions, such as Crohn's disease and rheumatoid arthritis. It works by blocking a key protein in the body that triggers swelling. Researchers hope that giving a single dose of infliximab shortly after symptoms begin will calm the inflammation in the pancreas early, protecting the body from wider damage.

During the trial, doctors will also study blood samples and genes to learn why some people develop more severe forms of the illness. This could help doctors in the future match treatments directly to individual patients. If successful, this trial could provide the NHS with its first effective drug treatment for acute pancreatitis, helping people leave hospital sooner and suffer fewer long-term complications.

Key takeaways

The trial tests if infliximab can reduce swelling and speed up recovery in acute pancreatitis.
Participants receive a single, two-hour drip of either infliximab or a dummy drug within 36 hours of hospital admission.
You will receive all your usual NHS care and pain relief throughout the trial.
Health checks and blood samples are monitored up to 90 days after treatment.
Taking part is completely voluntary and you can stop at any point without affecting your care.

Who may be eligible?

This trial is open to adults aged between 18 and 85 who have been diagnosed with acute pancreatitis and admitted through A&E or referred by their GP at a participating NHS hospital.

To join, doctors must confirm the diagnosis using at least two standard checks: typical severe upper tummy pain, blood tests showing high levels of digestive enzymes (amylase or lipase), or findings on an urgent scan.

Because the treatment needs to start very early to be effective, patients must be able to receive the trial medicine through a drip within 36 hours of arriving at the hospital. Patients or their legal representatives must also give fully informed consent before taking part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years of age?
Have you recently been admitted to a participating hospital with acute pancreatitis?
Did your symptoms include severe, sudden upper tummy pain?
Were you admitted to the hospital within the last 36 hours?
Are you able to provide consent (or have a legal representative provide it for you)?

Answer every question to see your result.

What does participation involve?

If you take part, you will be randomly chosen by a computer to receive either infliximab (at one of two dose levels) or a placebo, which is an inactive dummy medicine. Neither you nor your hospital doctors will know which one you receive. The medicine is given once through a small tube in your vein (an intravenous drip) over about two hours shortly after you are admitted.

While you stay in hospital, the medical team will track your symptoms, record your recovery, and take routine blood samples. You will have standard imaging checks, such as a chest X-ray and a CT scan of your tummy, to monitor your pancreas.

After you are discharged, the study team will continue to check on your health up to Day 90. In total, your participation lasts about three months from the day of your drip, with most activity happening during your normal hospital stay.

Potential risks and benefits

You might not get any direct personal benefit from taking part, especially if you receive the placebo, but infliximab could potentially reduce your swelling and help you recover faster. Your participation will also help doctors find better treatments for future patients. Infliximab is generally safe and well-tolerated, particularly when given as a single dose. Unlikely side effects include mild allergic reactions during the drip or a slightly higher risk of infection. You may also have routine X-rays or CT scans, which involve small amounts of radiation. Taking part is completely voluntary, and you can withdraw from the study at any time without your regular NHS care being affected.

Locations (9)

Royal Liverpool and Broadgreen University Hospitals NHS Trust (Lead Site)
City only
Liverpool, England
Leeds Teaching Hospital NHS Trust
City only
Leeds, England
John Radcliffe Hospital
Approximate
Oxford, England
Aberdeen Royal Infirmary
Approximate
Aberdeen, Scotland
University Hospital Aintree
Approximate
Liverpool, England
University College London Hospital
Unverified
London, England
Royal Devon and Exeter Hospital
Unverified
Exeter, England
University Hospital of Wales
Unverified
Cardiff, England
University Hospital of North Tees
Unverified
Stockton-on-tees, England

Common questions

What is a placebo and why is it used?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It allows researchers to compare the results fairly to see if infliximab genuinely works better than standard hospital care alone.

Will taking part delay my normal hospital treatment?

No. You will still receive all standard NHS care, including painkillers, fluids through a drip, and close monitoring, alongside the trial treatment.

Can I choose whether I get the active medicine or the placebo?

No. A computer assigns you to a group by chance. This random process ensures the trial results are completely unbiased and reliable.

What happens if I feel unwell during the infusion?

The infusion takes place in hospital where doctors and nurses will monitor you closely. If you develop any signs of an allergic reaction or feel uncomfortable, staff can slow down or stop the drip right away.

Do I have to travel for extra appointments after leaving hospital?

Most trial checks happen during your planned stay. Any follow-up checks up to Day 90 will be explained by the study team, and they will try to fit them around your routine care whenever possible.

How to find out more

Matthew Smyth

Rapid.One@liverpool.ac.uk +44 (0)151 794 9774 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.