Clinical trial NCT02002650: Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Official title: Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Keywords: Indomethacin, pancreatitis, ERCP
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;
* 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;

Primary outcomes:
measure: Post-ERCP Pancreatitis
timeFrame: 30 days
Secondary outcomes:
measure: Moderate-to-severe Pancreatitis
timeFrame: 30 days
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Yinchuan
country: China
facility: General Hospital of NingXia Medical University
state: Ningxia
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: No. 451 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital Of Xi'an Jiaotong University
state: Shaanxi
city: Urumqi
country: China
facility: Urumqi General Hospital of Lanzhou Military Region
state: Xinjiang
Study officials:
affiliation: Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
name: Yanglin Pan, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
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, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
citation: Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28.