Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac

July 7, 2023 updated by: Yanglin Pan, Air Force Military Medical University, China

Rectal Disclofenac Versus Indomethacin for Prevention of Post-ERCP Pancreatitis (DIPPP): A Multicentre, Double-blind, Randomised, Controlled Trial

Post-ERCP pancreatitis (PEP) is the most common complication after ERCP, which was associated with occasional mortality, prolonged hospital days and increased health costs. Some studies investigated the effectiveness of different Nonsteroidal antiinflammatory drugs (NSAIDs) for prevent PEP. However, several high-quality RCTs and meta-analyses consistently demonstrated only100mg rectal indomethacin or diclofenac significantly reduced PEP incidence compared with placebos. Thus, European Society of Gastrointestinal Endoscopy, American Society for Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines recommended rountine administration of 100mg rectal indomethacin or diclofenac in unselected patients who underwent ERCP.

Up to date, the mechanisms of NSAIDs in preventing pancreatitis were not fully elucidated. Diclofenac and Indomethacin showed similar inhibitory effects in phospholipase A2 and cyclooxygenase pathways. And the peak concentration of diclofenac and indomethacin both occurs between 30 and 90 min after rectal administration. However, diclofenac may be a stronger inhibitor of other pancreatitis-related imflammatory siginals (e.g. nuclear factor kappa-B) than indomethacin. Recently, several meta-analyses found 100mg rectal diclofenac to be more efficacious than 100mg rectal indomethacin. Despite these data, there is no conclusive evidence to prove that rectal diclofenac could provide incremental benefits over indomethacin from high-quality randomized, controlled trials. Therefore, the investigators conducted a multicenter, double-blind, randomized, controlled clinical trial to evaluate the efficacy of rectal diclofenac versus indomethacin for the prevention of post-ERCP pancreatitis in average-risk patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3612

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • Bo Ning, M.D.
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
        • Contact:
    • Hebei
      • Shijia Zhuang, Hebei, China, 050000
        • Recruiting
        • Department of Gastroenterology, The 980th Hospital of the PLA Joint Logistics Support Force
        • Contact:
    • Henan
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Department of Gastroenterology, Huaihe Hospital of Henan University
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
        • Contact:
        • Contact:
          • Genwang Wang, M.D.
          • Phone Number: +8613895689237
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Gastroenterology,The 986th Hospital of Xijing Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital of Digestive Diseases, Air Force Military Medical University, China
        • Contact:
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • Deparment of hepatobiliary surgery, The First Affiliated Hospital Of Xi'an Jiaotong University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Department of Gastroenterology and Endoscopy, Department of Gastroenterology and EndoscopyThe Third Affiliated Hospital of Naval Military Medical University
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Recruiting
        • Department of Gastroenterology, General Hospital of Xinjiang Military Region
        • Contact:
        • Contact:
          • Yun You
          • Phone Number: +8613565865240
        • Principal Investigator:
          • Jinshan Sun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-90 years old patients planned to undergo ERCP

Exclusion Criteria:

  • 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)
  • Previous biliary sphincterotomy and papillary large balloon dilation
  • Acute pancreatitis within 3 days before ERCP
  • Hemodynamical instability
  • Pregnancy or lactation
  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diclofenac group
Patients without contraindications in diclofenac group received 100mg rectal diclofenac 30 mins before ERCP procedure.
Drug: 100mg diclofenac
All patients without contraindications should receive 100mg rectal diclofenac 30mins before ERCP procedure
Active Comparator: Indomethacin group
Patients without contraindications in indomethacin group received 100mg rectal indomethacin 30 mins before ERCP procedure.
Drug: 100mg indomethacin
All patients without contraindications should receive 100mg rectal indomethacin 30mins before ERCP procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-ERCP Pancreatitis
Time Frame: 30 days
The diagnosis of post-ERCP pancreatitis was confirmed if there was new onset of upper abdominal pain associated with an increased amylase or lipase level of at least 3 times the upper limit of normal range at 24 hours after ERCP, accompanied with extension of hospitalization for at least 2 nights.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of moderate or severe PEP
Time Frame: 30 days
The severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.
30 days
Rate of Overall ERCP-related complications
Time Frame: 30 days
ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
30 days
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
Time Frame: 30 days
30 days
Rate of NSAIDs-related complications
Time Frame: 30 days
NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality
Time Frame: 30 days
30 days
Rate of ERCP-related perforation
Time Frame: 30 days
Perforation was established according to Cotton criteria
30 days
Rate of ERCP-related infection
Time Frame: 30 days
Infection was established according to Cotton criteria
30 days
Rate of ERCP-related bleeding
Time Frame: 30 days
Bleeding was established according to Cotton criteria
30 days
Number of hospital days after ERCP
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232165-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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