Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac

Last updated: October 24, 2024
Sponsor: Air Force Military Medical University, China
Overall Status: Terminated

Phase

N/A

Condition

Pancreatitis

Treatment

100mg indomethacin

100mg diclofenac

Clinical Study ID

NCT05947461
KY20232165-C-1
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-90 years old patients planned to undergo ERCP

Exclusion

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 theprocedure)

  • 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 Design

Total Participants: 1204
Treatment Group(s): 2
Primary Treatment: 100mg indomethacin
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
June 22, 2024

Connect with a study center

  • Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400010
    China

    Site Not Available

  • Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital

    Xiamen, Fujian 361000
    China

    Site Not Available

  • Department of Gastroenterology, The 980th Hospital of the PLA Joint Logistics Support Force

    Shijia Zhuang, Hebei 050000
    China

    Site Not Available

  • Department of Gastroenterology, Huaihe Hospital of Henan University

    Kaifeng, Henan 475000
    China

    Site Not Available

  • Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • Deparment of hepatobiliary surgery, The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Department of Gastroenterology,The 986th Hospital of Xijing Hospital

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710000
    China

    Site Not Available

  • Xijing Hospital of Digestive Diseases, Air Force Military Medical University, China

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Department of Gastroenterology and Endoscopy, Department of Gastroenterology and EndoscopyThe Third Affiliated Hospital of Naval Military Medical University

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Department of Gastroenterology, General Hospital of Xinjiang Military Region

    Urumqi, Xinjiang 830000
    China

    Site Not Available

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