NCT02111707

Brief Summary

To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
534

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

April 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3.4 years

First QC Date

April 9, 2014

Last Update Submit

October 24, 2017

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Rate of Post-ERCP pancreatitis

    30 days

Secondary Outcomes (1)

  • Severity of Post-ERCP pancreatitis

    30 days

Study Arms (2)

Rectal Indomethacin pre-ERCP

ACTIVE COMPARATOR

Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).

Drug: Rectal indomethacin 100mg one time before or after ERCP

Rectal Indomethacin post-ERCP

ACTIVE COMPARATOR

Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)

Drug: Rectal indomethacin 100mg one time before or after ERCP

Interventions

Rectal indomethacin 100mg one time before or after ERCPDRUG

Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.

Also known as: Indocid 100mg
Rectal Indomethacin post-ERCPRectal Indomethacin pre-ERCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients referred for ERCP at the University of Alberta
  • Age greater than 18 years
  • Ability to provide written informed consent

You may not qualify if:

  • Acute pancreatitis
  • Active peptic ulcer disease
  • Rectal disease
  • Aspirin-induced asthma
  • Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity
  • Pregnancy
  • Breast feeding
  • Creatinine clearance \< 30 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2X8, Canada

Location

Related Publications (4)

  • Sotoudehmanesh R, Khatibian M, Kolahdoozan S, Ainechi S, Malboosbaf R, Nouraie M. Indomethacin may reduce the incidence and severity of acute pancreatitis after ERCP. Am J Gastroenterol. 2007 May;102(5):978-83. doi: 10.1111/j.1572-0241.2007.01165.x. Epub 2007 Mar 13.

    PMID: 17355281RESULT

  • 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.

    PMID: 22494121RESULT

  • Murray B, Carter R, Imrie C, Evans S, O'Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology. 2003 Jun;124(7):1786-91. doi: 10.1016/s0016-5085(03)00384-6.

    PMID: 12806612RESULT

  • Montano Loza A, Rodriguez Lomeli X, Garcia Correa JE, Davalos Cobian C, Cervantes Guevara G, Medrano Munoz F, Fuentes Orozco C, Gonzalez Ojeda A. [Effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes]. Rev Esp Enferm Dig. 2007 Jun;99(6):330-6. doi: 10.4321/s1130-01082007000600005. Spanish.

    PMID: 17883296RESULT

MeSH Terms

Conditions

Pancreatitis

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 11, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 25, 2017

Record last verified: 2017-09

Locations

CA(1)