A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis

NCT00727740 | Completed Results

• 1 other identifier: 0502027420
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if indomethacin, an anti-inflammatory medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs) can reduce the risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography (ERCP.) The hypothesis is that indomethacin decreases the incidence and severity of post-ERCP pancreatitis. Patients who are scheduled to undergo a ERCP will be enrolled. Following ERCP, patients will be randomized to receive a dose of indomethacin or placebo (an inactive substance) instilled into the duodenum via the biopsy channel of the duodenoscope. All patients will be observed for 4 hours following ERCP which is part of routine clinical practice. Patients with minimal pain will be discharged after this 4 hour observation period. All patients will have baseline serum amylase levels which are repeated 2 to 4 hours after the ERCP has been completed. Patients who have significant abdominal pain will be hospitalized and evaluated for pancreatitis. Patients discharged to home will be contacted by telephone the following day to ask them if they have had any complications of ERCP.

Conditions

Pancreatitis

Keywords

Cholangiopancreatography, Endoscopic Retrograde; Pancreatitis; Indomethacin

Outcome Measures

Primary Outcomes (1)

• Reduction in Pancreatitis Rate

  Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.

  24 hours

Study Arms (2)

1

EXPERIMENTAL

Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Drug: Indomethacin

2

PLACEBO COMPARATOR

Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.

Drug: Placebo suspension

Interventions

Indomethacin DRUG

Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

1

Placebo suspension DRUG

A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.

2

Eligibility Criteria

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

You may qualify if:

• Patients undergoing ERCP as part of their clinical care.

You may not qualify if:

• Pancreatitis within 60 days of ERCP
• Age less than 18 years
• Pregnant patients
• Patients who have received NSAIDs within the past 7 days
• Patients with a previous allergy to NSAIDs
• Patients who were previously enrolled in the study
• Patients with a history of peptic ulcers, gastrointestinal bleeding, on anticoagulants and/or with a bleeding diathesis.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

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

Results Point of Contact

• Title: Priya Jamidar, MD
• Organization: Yale University School of Medicine

priya.jamidar@yale.edu

203-785-6228

Study Officials

• Priya Jamidar, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 4, 2008
• Study Start: August 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: January 18, 2017
• Results First Posted: January 18, 2017

Record last verified: 2016-11

Locations

US (1)