NCT02709421

Brief Summary

Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been proved to be effective in reducing the incidence of PEP. It has been widely used to prevent PEP in patients, especially those with potentially high risks of PEP. However, rectal indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients receiving rectal indomethacin remains unclear. The aim of the study was to identify potential risk factors in high-risk patients whose received administration of prophylactic rectal indomethacin after ERCP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
790

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 5, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

February 29, 2016

Last Update Submit

September 1, 2016

Conditions

Healthy

Keywords

post-Endoscopic Retrograde cholangiopancreatography pancreatitisRisk factorsIndomethacin

Outcome Measures

Primary Outcomes (1)

  • Overall PEP rate

    PEP was defined if patients experienced abdominal pain for more than 24h after procedure, accompanying with amylase or lipase ≥ 3 times equal to the upper limit of normal value.

    1 year

Secondary Outcomes (2)

  • The rate of moderate-severe pancreatitis

    1 year

  • Overall ERCP-related complication rate

    1 year

Study Arms (1)

Indomethacin Group

All the patients with high risks of PEP received administration of one single dose of 100mg rectal indomethacin after ERCP. Patients were considered high risk of PEP if they met one of the following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, ≥8 cannulation attempts, cannulation time≥10 minutes; pneumatic dilatation of an intact biliary sphincter, ≥3 inadvertent pancreatic duct cannulation, opacification of pancreatic acini, or the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush or forceps.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent ERCP and received administration of rectal indomethacin.

You may qualify if:

  • Undergoing diagnostic or interventional ERCP
  • Receiving administration of rectal indomethacin(100mg) after ERCP
  • High risk patients determined at the discretions of endoscopists

You may not qualify if:

  • Dose other than 100mg
  • Acute pancreatitis within 3 days before ERCP
  • Average risk patients at the discretions of endoscopists
  • Using NSAIDs within 7 days before ERCP
  • Without cannulation attempts
  • Administration of rectal indomethacin before or during ERCP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of gastroenterology,Chinese PLA 174 Hospital

Xiamen, Fujian, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Location

Related Publications (3)

  • Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.

    PMID: 25148137BACKGROUND

  • Yaghoobi M, Rolland S, Waschke KA, McNabb-Baltar J, Martel M, Bijarchi R, Szego P, Barkun AN. Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013 Nov;38(9):995-1001. doi: 10.1111/apt.12488. Epub 2013 Sep 16.

    PMID: 24099466BACKGROUND

  • Kang X, Zheng L, Zeng W, Yang S, Sun H, Zhang R, Wang X, Wang B, Tao Q, Yao S, Chen J, Pan Y, Guo X. Risk Factors for Post-ERCP Pancreatitis in High-Risk Patients Receiving Post-procedure Rectal Indomethacin. J Gastrointest Surg. 2018 Nov;22(11):1903-1910. doi: 10.1007/s11605-018-3864-0. Epub 2018 Jul 6.

    PMID: 29980976DERIVED

Study Officials

  • Yanglin Pan

    Xijing Hospital of Disgestive Diseases.The Fourth Military University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 16, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-06

Locations

CN(3)