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

NCT03713879 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1734

Last updated 2025-02-12

No results posted yet for this study

Summary

Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.

Conditions

  • Post ERCP Pancreatitis

Interventions

DEVICE

pancreatic stenting

a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025" or .035" wire)

DRUG

Indomethacin

rectally administered indomethacin before or after ERCP

Sponsors & Collaborators

  • Xijing Hospital

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • Tianjin Union Medical Center

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Eastern Hepatobiliary Surgery Hospital

    collaborator OTHER

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • James LAU, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China
  • Hong Kong
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03713879 on ClinicalTrials.gov