Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01774604
• Other study ID #: CPHS#23749
• Status: Terminated
• Phase: Phase 3
• First received: January 21, 2013
• Last updated: February 25, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 449
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Scheduled for an ERCP at Dartmouth-Hitchcock

2. Age greater than 18 years old

3. Ability to provide written informed consent

Exclusion Criteria:

1. Inability to provide written informed consent

2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis

3. Current ongoing acute pancreatitis

4. Previously documented allergy to NSAID

5. Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)

6. Pregnant or nursing mothers

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Drug:
• Indomethacin
100 mg Indomethacin PR x 1
• Placebo

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of post-ERCP pancreatitis in all patients	Assess whether rectal indomethacin, compared to placebo, will lower the rate of post-ERCP pancreatitis in all patients	30 days	Yes
Secondary	Severity of post-ERCP pancreatitis	Assess the difference in severity of post-ERCP pancreatitis in patients who develop this condition	30 days	Yes
Secondary	Post-fine needle aspiration pancreatitis in setting of concomitant ERCP/EUS	Assess the rates of post-fine needle aspiration (FNA) pancreatitis in the setting of concomitant ERCP/endoscopic ultrasound examinations	30 days	Yes