Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Not Applicable

Completed

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Drug: Pre-ERCP rectal Indomethacin; Drug: Post-operational Rectal Indomethacin

• Registration Number: NCT02002650
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-01
• Study First Posted: 2013-12-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2016-04-17
• Results First Submitted QC: 2016-04-21
• Status Verified: 2016-05
• Results First Posted: 2016-05-27
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2600

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-ERCP group	Pre-ERCP rectal Indomethacin	Pre-ERCP rectal Indomethacin in all patients.
Post-ERCP group	Post-operational Rectal Indomethacin	Post-ERCP rectal Indomethacin in high-risk patients.

Primary Outcome Measures

Name	Time	Method
Post-ERCP Pancreatitis	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 Outcome Measures

Name	Time	Method
Moderate-to-severe Pancreatitis	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).

Trial Locations

Locations (6)

General Hospital of NingXia Medical University; 🇨🇳 Yinchuan, Ningxia, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

The First Affiliated Hospital Of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

No. 451 Hospital; 🇨🇳 Xi'an, Shaanxi, China

Urumqi General Hospital of Lanzhou Military Region; 🇨🇳 Urumqi, Xinjiang, China