Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

NCT01912716 | Completed Phase 2 Results DMC

• 2 other identifiers: PEP INDO 2013ACG-CR-002-2013
• Study Type: interventional
• Target: 1,037
• Locations: 1 country
• Sites: 6

Brief Summary

It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients. However, the optimal dose required is not known. The purpose of this study is to determine whether a dose of 200 mg, administered as rectal suppositories, is more effective than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube with a camera is passed down the patient's throat and allows for evaluation of the bile duct and/or pancreatic duct. The most common side effect of this procedure is post-ERCP pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this complication than others. Our hypothesis is to compare the efficacy of these two dose regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the frequency and severity of post-ERCP pancreatitis in high-risk patients.

Conditions

Post-ERCP Pancreatitis

Keywords

pancreatitis; ERCP

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Post-ERCP Pancreatitis

  Assessment of whether patients developed post-ERCP pancreatitis, defined as a new onset of pain (or worsening of existing pain) in the upper abdomen, an elevation in pancreatic enzymes of at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least two nights.

  5 days

Secondary Outcomes (1)

• Number of Participants With Moderate or Severe Post-ERCP Pancreatitis

  30 days

Study Arms (2)

high-dose indomethacin

EXPERIMENTAL

200mg rectal indomethacin

Drug: high dose indomethacin

standard dose indomethacin

ACTIVE COMPARATOR

100mg rectal indomethacin

Drug: standard dose indomethacin

Interventions

high dose indomethacin DRUG

patients randomized to this intervention receive 200mg indomethacin

Also known as: Indocin

high-dose indomethacin

standard dose indomethacin DRUG

patients randomized to this intervention receive 100mg indomethacin

Also known as: Indocin

standard dose indomethacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Included patients are those undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and have:
• one of the following:
• Clinical suspicion of sphincter of Oddi dysfunction (SOD; type I or II)
• History of post-ERCP pancreatitis (at least one episode)
• Pancreatic sphincterotomy
• Pre-cut (access) sphincterotomy
• greater than 8 cannulation attempts of any sphincter
• Pneumatic dilation of intact biliary sphincter
• Ampullectomy 8.) Assessment for post-sphincterotomy stenosis
• OR at least 2 of the following:
• Age less than 50 years old and female gender
• History of recurrent pancreatitis (at least 2 episodes)
• greater than or equal to to 3 pancreatic injections, with at least 1 injection to tail
• Pancreatic acinarization (excluding ventral pancreas of pancreas divisum)
• Pancreatic brush cytology -

You may not qualify if:

• Unwillingness or inability to consent for the study
• Age less than 18 years
• Intrauterine pregnancy
• Breastfeeding mother
• Standard contraindications to ERCP
• Allergy/hypersensitivity to aspirin or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
• Received NSAIDs in prior 7 days (aspirin 325mg or less ok)
• Renal failure (serum creatinine greater than 1.4)
• Active or recurrent (within 4 weeks) gastrointestinal hemorrhage
• Acute pancreatitis (lipase peak) within 72 hours
• Known chronic calcific pancreatitis
• Pancreatic head mass
• Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (dorsal duct not attempted on injected)
• ERCP for biliary stent removal or exchange without anticipated pancreatogram
• Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram

Sponsors & Collaborators

• Indiana University: lead
• American College of Gastroenterology: collaborator
• University of Michigan: collaborator
• University of Texas: collaborator
• Wake Forest University Health Sciences: collaborator
• Medical University of South Carolina: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (6)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Aurora St. Lukes' Medical Center

Milwaukee, Wisconsin, 53220, United States

Location

Related Publications (1)

• Fogel EL, Lehman GA, Tarnasky P, Cote GA, Schmidt SE, Waljee AK, Higgins PDR, Watkins JL, Sherman S, Kwon RSY, Elta GH, Easler JJ, Pleskow DK, Scheiman JM, El Hajj II, Guda NM, Gromski MA, McHenry L Jr, Arol S, Korsnes S, Suarez AL, Spitzer R, Miller M, Hofbauer M, Elmunzer BJ; US Cooperative for Outcomes Research in Endoscopy (USCORE). Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):132-141. doi: 10.1016/S2468-1253(19)30337-1. Epub 2019 Nov 25.

  PMID: 31780277 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This study took place at 6 tertiary medical centers in the United States. However, approximately 3/4 of patients were enrolled from a single site.

Results Point of Contact

• Title: Dr. Evan Fogel
• Organization: Indiana University

efogel@iu.edu

317-944-2816

Study Officials

• Evan L Fogel, MD, MSc

  Indiana University Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 5, 2019
• Results First Posted: June 18, 2019

Record last verified: 2019-06

Locations

US (6)