Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Post-ERCP Acute Pancreatitis Clinical Trial

— Indomethacin  

Official title:

A Prospective, Randomized, Controlled Trial of Pre-operational Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in Average-risk Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002650
• Other study ID #: 20131106-7
• Secondary ID: 20131106-7
• Status: Completed
• Phase: N/A
• First received: December 1, 2013
• Last updated: February 2, 2016
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Drug:
• Pre-operational rectal Indomethacin
Rectal Indomethacin was administrated within 30min before ERCP for all patients.
• Post-operational Rectal Indomethacin
Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients.

Locations

Country	Name	City	State
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Urumqi General Hospital of Lanzhou Military Region	Urumqi	Xinjiang
China	No. 451 Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital Of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	General Hospital of NingXia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc. 2012 Dec;76(6):1152-9. doi: 10.1016/j.gie.2012.08.021. — View Citation

Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nichols — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP Pancreatitis	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.	7 days	Yes
Secondary	Severity of pancreatitis		30 days	Yes