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Which NSAID is best? large trial tests indomethacin vs diclofenac to prevent Post-ERCP pancreatitis

NCT ID NCT07071441

Prevention Sponsor: Air Force Military Medical University, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two rectal non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and diclofenac, to see which one better prevents pancreatitis after an ERCP procedure. About 4050 adults aged 18-90 with an intact papilla will be randomly assigned to receive one of the drugs before the procedure. The goal is to find out if indomethacin is superior to diclofenac in reducing the risk of this common complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indomethacin and diclofenac (non-steroidal anti-inflammatory drugs, given as rectal suppositories)
What this could lead to
If it works, this could show that indomethacin is better than diclofenac at preventing pancreatitis after ERCP, helping doctors choose the most effective preventive drug.
What could go wrong
This is a large trial, but it follows an earlier smaller study that was stopped early. The difference between the two drugs may still be small, and individual patient factors could affect results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 4,050 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18-90 years old patients with native papilla who planned to undergo ERCP Exclusion Criteria: * Previous biliary sphincterotomy and papillary large balloon dilation * Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy) * Allergy to NSAIDs * The administration of NSAIDs within 7 days * Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \[Cr \>1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure) * Acute pancreatitis within 7 days before ERCP or acute pancreatitis with obvious Pancreatic edema and peripancreatic fluid collections * Hemodynamical instability * Pregnancy or lactation * Unable to give informed consent

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Conditions

The condition(s) this trial relates to.

pancreatitis acute pancreatitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diclofenac ERCP Indomethacin Non-steroidal anti-inflammatory (nsaid) Pancreatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 986 Hospital of Xijing Hospital

    RECRUITING

    Xi'an, Shaanxi, 710000, China

  • Affiliated Hangzhou First People's Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Department of Gastroenterology, Hongai Hospital

    RECRUITING

    Xiamen, Fujian, 361000, China

  • Eastern Hepatobiliary Surgery Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Harbin Medical University Affiliated Fourth Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Huaihe Hospital of Henan University

    RECRUITING

    Kaifeng, Hennan, 475000, China

  • Jilin Miniciple People'S Hospital

    RECRUITING

    Jilin City, Jilin, 132000, China

  • Qinghai University Affiliated Hospital

    RECRUITING

    Xining, Qinghai, 810000, China

  • Renmin hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710000, China

  • Shandong Provincial Third Hospital

    NOT_YET_RECRUITING

    Jinan, Shandong, 250000, China

  • The 960th Hospital of the PLA

    RECRUITING

    Jinan, Shandong, 250000, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 404100, China

  • The Third Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, 410000, China

  • The first medical center, Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Xijing Hospital of Digestive Diseases

    RECRUITING

    Xi'an, Shaanxi, 710000, China

  • [email protected]

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • the First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • the second Affiliated Hospital, Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310000, China

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