Actively Recruiting

Phase 3
Age: 18Years - 99Years
All Genders
ID03713879

Comparative Effectiveness Between Rectally Administered Indomethacin and Pancreatic Stenting in the Prevention of Post Endoscopic Retrograde Cholangio-panceaticography (ERCP) Pancreatitis: a Randomized Trial

Led by Chinese University of Hong Kong · Updated on 2025-02-12

1734

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Chinese University of Hong Kong

Lead Sponsor

X

Xijing Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two methods to prevent pancreatitis that can occur after Endoscopic Retrograde Cholangiopancreatography (ERCP), a procedure used to examine the pancreas and bile ducts. This trial focuses on patients at high risk of developing post-ERCP pancreatitis (PEP), which affects about 4 to 5% of patients and can cause serious health issues or even death. The study aims to see whether rectally administered indomethacin or pancreatic duct stenting (PDS) is more effective in preventing PEP, as the best prevention method is still unclear. Participants are randomly assigned to one of three groups: one group receives 100 mg of rectal indomethacin before or after ERCP; another group has a pancreatic duct stent inserted during ERCP; and a third group receives both indomethacin and the stent. The stent used is a 3 to 5 cm 5Fr single pigtail pancreatic duct stent. The study compares these treatments to evaluate their success in preventing pancreatitis. During the study, participants will be monitored for up to 30 days after ERCP to check for the development of pancreatitis, including its severity and any related complications. Researchers will track hospital stays and any need for additional interventions like endoscopic, radiologic, or surgical treatments due to pancreatitis. The trial involves detailed follow-up to assess outcomes and safety over this period, with careful documentation of any pancreatitis cases.

CONDITIONS

Brief Title

Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 99 years
  • Presence of one or more risk factors for post ERCP pancreatitis such as sphincter of Oddi dysfunction, history of post ERCP pancreatitis, pancreatic instrumentation or sphincterotomy, precut sphincterotomy
  • Difficult cannulation defined by more than 5 cannulation attempts
  • Use of double wire technique in bile duct access
  • At least two of the following: female under 50 years, three pancreatograms, acinarization (contrast injection to tail of pancreas), normal bilirubin, guidewire to tail of pancreas or secondary branches
Not Eligible

You will not qualify if you...

  • Patients intended for pancreatic stenting due to pancreatic duct strictures or ampullectomy
  • Lack of informed consent from patient or next of kin
  • Age under 18 years
  • Pregnant or lactating women
  • Patients with altered anatomy except Billroth I and II gastrectomy
  • Contraindications to NSAIDs such as active gastrointestinal bleeding or renal failure with serum creatinine over 140
  • Known allergy to NSAIDs
  • Incipient heart failure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day (day of ERCP procedure)

Participants receive either rectal indomethacin, pancreatic duct stenting, or both during the ERCP procedure to prevent post-ERCP pancreatitis.

1 procedure visit (in-person)

Follow-up

Duration - 30 days

Participants are monitored for complications and outcomes related to post-ERCP pancreatitis.

Approximately 1 to 3 visits (in-person or remote) during 30 days

Trial Site Locations

Total: 7 locations

1

Endoscopy centre

Xi'an, Shaanxi, China, 710000

Actively Recruiting

2

Eastern Hepatobiliary Surgery Hospital,Endoscopy centre

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

3

Endoscopy centre

Shanghai, Shanghai Municipality, China, 200000

Not Yet Recruiting

4

Endoscopy centre

Tianjin, Tianjin Municipality, China, 300000

Actively Recruiting

5

Endoscopy centre

Hangzhou, Zhejiang, China, 310013

Actively Recruiting

6

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, Hong Kong, Hong Kong

Actively Recruiting

7

2. Chulalongkorn University and King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Actively Recruiting

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Research Team

J

James LAU, MD

R

RAYMOND TANG, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

Frequently Asked Questions

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Published Research Related To This Trial

[Effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes].

A Montaño Loza, X Rodríguez Lomelí, J E García Correa...

https://pubmed.ncbi.nlm.nih.gov/17883296

Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial.

Taiga Otsuka, Seiji Kawazoe, Shunya Nakashita...

https://pubmed.ncbi.nlm.nih.gov/22350703

Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial.

P Katsinelos, K Fasoulas, G Paroutoglou...

https://pubmed.ncbi.nlm.nih.gov/22198776

Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.

B Joseph Elmunzer, Peter D R Higgins, Sameer D Saini...

https://pubmed.ncbi.nlm.nih.gov/23295278