Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Pre-ERCP rectal Indomethacin
- Conditions
- Post-ERCP Acute Pancreatitis
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 2600
- Locations
- 6
- Primary Endpoint
- Post-ERCP Pancreatitis
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Yanglin Pan
Associated professor
Air Force Military Medical University, China
Eligibility Criteria
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;
Arms & Interventions
Pre-ERCP group
Pre-ERCP rectal Indomethacin in all patients.
Intervention: Pre-ERCP rectal Indomethacin
Post-ERCP group
Post-ERCP rectal Indomethacin in high-risk patients.
Intervention: Post-operational Rectal Indomethacin
Outcomes
Primary Outcomes
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
- Moderate-to-severe Pancreatitis(30 days)