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Completed

NCT Number: NCT02002650

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.

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Key information

Conditions

Post-ERCP Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Lanzhou University, Lanzhou, Gansu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing diagnostic or therapeutic ERCP.

Exclusion criteria

  • Unwillingness or inability to consent for the study;
  • Age < 18 years old;
  • Intrauterine pregnancy;
  • Breastfeeding mother;
  • Standard contraindications to ERCP;
  • Allergy to NSAIDs;
  • Received NSAIDs in prior 7 days;
  • Renal failure (Cr >1.4mg/dl=120umol/l);
  • Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
  • Acute pancreatitis within 72 hours;
  • Known pancreatic head mass;
  • Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
  • ERCP for biliary stent removal or exchange without anticipated pancreatogram;
  • Known active cardiovascular or cerebrovascular disease.
  • Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;

Treatment and study plan

Pre-ERCP rectal Indomethacin

Drug

Rectal Indomethacin was administrated within 30min before ERCP in all patients.

Post-operational Rectal Indomethacin

Drug

Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Primary outcomes

  1. Post-ERCP Pancreatitis

    Time frame: 30 days

    Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.

Secondary outcomes

  1. Moderate-to-severe Pancreatitis

    Time frame: 30 days

    Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial

Acronym: Indomethacin

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2013
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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