DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017