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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026 Site details revised at 1 of 7 sites · Collaborators revised (5)v7 Show 2 more changesShow less
    • Site details revised at 1 of 7 sites
    • Collaborators revised (5)

    See this version in full on ClinicalTrials.gov ↗

  2. 3 versions Re-verified since Jul 26, 2021, no change to tracked fieldsv4-v6
  3. Primary completion date: Dec 31, 2022 to Dec 31, 2025 Study sites: 6 to 7 · Completion date: Dec 31, 2023 to Dec 31, 2025 · Study title shortened, about 2 wordsv3 Show 3 more changesShow less
    • Study sites: 6 to 7
    • Completion date: Dec 31, 2023 to Dec 31, 2025
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 6 · Start date changed from estimate of Jan 1, 2019 to Mar 21, 2019 · Eligibility criteria expanded, about 12 words · 1 morev2 Show 4 more changesShow less
    • Study sites: 1 to 6
    • Start date changed from estimate of Jan 1, 2019 to Mar 21, 2019
    • Eligibility criteria expanded, about 12 words
    • Collaborators: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03713879
Lead Sponsor Chinese University of Hong Kong
Collaborators: Xijing Hospital, Changhai Hospital, Tianjin Union Medical Center, First Affiliated Hospital of Zhejiang University, Eastern Hepatobiliary Surgery Hospital
Conditions Post ERCP Pancreatitis
Enrollment 1,734 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov