RecruitingNAINTERVENTIONAL

Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.

This research study is investigating if lidocaine, a common numbing medicine, can reduce the risk of a painful condition called pancreatitis after a stomach procedure known as ERCP. Pancreatitis can be a serious complication, and doctors are always looking for ways to prevent it. Patients taking part will already be receiving standard preventive medicine for pancreatitis. They will be split into two groups by chance: one group will receive lidocaine as part of their general anaesthetic during the ERCP, and the other group will not. The study aims to compare how many people in each group develop pancreatitis afterwards to see if lidocaine offers extra protection. All patients will be monitored carefully.

At a glance

Status

Recruiting

Phase

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

1,800

Start

18 Jan 2024

Estimated completion

28 Feb 2026

ERCP Surgery

What is this study about?

This study is focused on a procedure called ERCP, which is used to look at and treat problems in your bile ducts and pancreas. A possible complication after an ERCP is developing pancreatitis, which is an inflammation of the pancreas and can be quite painful. Doctors want to find the best ways to reduce this risk.

In this study, researchers are exploring if a medicine called lidocaine can help prevent pancreatitis after an ERCP. Lidocaine is often used as a local anaesthetic (like at the dentist) but can also be given through a vein during surgery. All patients in this study will already receive another standard preventative medicine for pancreatitis called indomethacin. They will then be randomly assigned to one of two groups. One group will receive lidocaine as part of their general anaesthetic during the ERCP procedure, and the other group will have general anaesthetic without lidocaine.

The main goal is to compare how many people in each group develop pancreatitis after their ERCP. By comparing the groups, doctors hope to learn if adding lidocaine to the anaesthetic makes it less likely for patients to get pancreatitis, potentially improving the safety of the ERCP procedure for many people.

Key takeaways

This study evaluates if lidocaine can help prevent pancreatitis after an ERCP.
Patients will be randomly assigned to receive lidocaine or not during general anaesthesia.
All patients will also receive standard preventative medicine for pancreatitis.
The aim is to see if lidocaine lowers the chance of developing pancreatitis.
Participation involves no extra visits, just different anaesthetic during your ERCP.

Who may be eligible?

To join this study, you need to be at least 18 years old and having your first ERCP procedure. This means you haven't had a procedure previously that changed the opening of your bile duct (called your papilla).

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you can't use certain pain-relieving medicines (NSAIDs). You also can't take part if you are already in another research study or if you have any conditions that would make it unsafe for you to have a general anaesthetic or use lidocaine.

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 18 years or older?
Are you having an ERCP for the first time?
Are you currently pregnant or breastfeeding?
Do you have any conditions that stop you from having a general anaesthetic or lidocaine?
Can you safely take anti-inflammatory medicines (NSAIDs)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of two groups. This is like flipping a coin to decide, so neither you nor your doctor can choose which group you are in. Both groups will receive a standard preventive medicine (indomethacin) just before your ERCP.

During your ERCP, you will have a general anaesthetic. If you are in the lidocaine group, you will receive lidocaine during this anaesthetic. If you are in the other group, you will not. Your blood pressure and hydration will be carefully managed, and you will receive pain relief afterwards as needed. The study will mainly look at whether you develop pancreatitis after the procedure. All your regular medical care for the ERCP will continue as normal.

Potential risks and benefits

The potential benefit of taking part is that lidocaine *might* reduce your risk of developing pancreatitis after your ERCP. However, this is what the study is trying to find out, so there's no guarantee. All medications and procedures carry some risks, and your doctor will discuss the potential side effects of general anaesthesia and lidocaine with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpital Privé des Peupliers
Verified postcode
Paris, France· Recruiting

Common questions

What is ERCP?

ERCP is a procedure used by doctors to look at and treat problems in the bile ducts and pancreas, which are organs involved in your digestion.

What is pancreatitis?

Pancreatitis is when your pancreas becomes inflamed, which can cause severe pain and sometimes other serious health problems.

Will I know if I'm getting lidocaine?

You will be randomly assigned to a group, but you won't be told whether you received lidocaine during your anaesthetic. This is to ensure the results of the study are as accurate as possible.

What is a 'virgin papilla'?

This simply means you haven't had a previous ERCP or surgery that changed specific ducts in your digestive system, making sure the study is comparing similar patients.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.

How to find out more

Gianfranco DONATELLI, MD

donatelligianfranco@gmail.com 01 44 16 52 00 Official trial record

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