Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Information source: Fourth Military Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-ERCP Acute Pancreatitis
Intervention: Pre-operational rectal Indomethacin (Drug); Post-operational Rectal Indomethacin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Fourth Military Medical University Official(s) and/or principal investigator(s): Yanglin Pan, M.D., Study Director, Affiliation: Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
Overall contact: Yanglin Pan, M.D., Phone: 86-29-84771536, Email: panyl@fmmu.edu.cn
Summary
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to
30% of procedures. A number of trials have evaluated that rectal NSAIDs (non-steroidal
anti-inflammatory drug) can prevent post-ERCP pancreatitis (PEP) in high risk patients.
However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all
patients, not just for selected high-risk factor patients, may preventing the PEP maximum.
The purpose of this study is to determine whether routine using of rectal indomethacin is
more effective than the conditional regimen.
Clinical Details
Official title: A Prospective, Randomized, Controlled Trial of Pre-operational Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in Average-risk Patients.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Post-ERCP Pancreatitis
Secondary outcome: Severity of pancreatitis
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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;
- Known chronic calcific pancreatitis, pancreatic divisum or 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.
Locations and Contacts
Yanglin Pan, M.D., Phone: 86-29-84771536, Email: panyl@fmmu.edu.cn
The First Hospital of Lanzhou University, Lanzhou, Gansu 730000, China; Recruiting Wence Zhou, M.D., Email: zhouwc129@163.com Wence Zhou, M.D., Principal Investigator
General Hospital of NingXia Medical University, Yinchuan, Ningxia 750004, China; Recruiting Qi Wang, M.D., Phone: 8613895098592, Email: wq-6562@163.com Ming Li, M.D., Phone: 8613519216501, Email: nyfygdwk@163.com Ming Li, M.D, Principal Investigator
No. 451 Hospital, Xi'an, Shaanxi 710054, China; Recruiting Yi Zhou, M.D., Phone: 8613399289251, Email: Zhouyi02192005@aliyun.com Yi Zhou, M.D., Principal Investigator
The First Affiliated Hospital Of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, China; Recruiting Hao Sun, M.D., Phone: 862985323905, Email: Sunhaoxjyf@126.com Hao Sun, M.D., Principal Investigator
Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi 710032, China; Recruiting Yanglin Pan, M.D., Phone: 86-29-84771536, Email: panyl@fmmu.edu.cn Hui Luo, M.D., Phone: 86-29-84771536, Email: fmmulh@163.com Hui Luo, M.D., Principal Investigator
Urumqi General Hospital of Lanzhou Military Region, Urumqi, Xinjiang 830002, China; Recruiting Zhan Guo, M.D., Phone: 8613999116558, Email: niezg@vip.sina.com Ting Lei, M.D., Phone: 8618999838871, Email: lting.xj@163.com Ting Lei, M.D., Principal Investigator
Additional Information
Starting date: December 2013
Last updated: June 5, 2015
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