Diclofenac for Prevention of Post-ERC Pancreatitis

NCT03595150 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Post-ERCP-01
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims at assessing the effectiveness of Diclofenac for prevention of post-ERCP pancreatitis. It will be undertaken embedded in the Swedish national register for Gallstone surgery and ERCP (GallRiks). Patients are randomised to Diclofenac prior to the ERCP or no prophylaxis. GallRiks is used to identify which patients fulfill the eligibility criteria and which patients develop pancreatitis after the ERCP.

Conditions

Common Bile Duct Diseases

Keywords

Endoscopic Retrograde Cholangiopancreatography; Pancreatitis; Diclofenac

Outcome Measures

Primary Outcomes (1)

• Post-ERCP pancreatitis

  Acute pancreatitis recorded in GallRiks by responsible endoscopist or surgeon. According to GallRiks criteria pancreatitis includes elevated amylase and abdominal pain of an intensity that hospital stay is warranted.

  Within 30 days post-ERCP

Secondary Outcomes (2)

• Adverse drug reactions

  Within 30 days post-ERCP

• Mortality

  Within 30 days post-ERCP

Study Arms (2)

Diclofenac

ACTIVE COMPARATOR

100 mg Diclofenac rectally prior to the ERCP

Drug: Diclofenac

No prophylaxis

NO INTERVENTION

No prophylaxis

Interventions

Diclofenac DRUG

Diclofenac rectally given before the ERCP to prevent pancreatitis

Diclofenac

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

You may not qualify if:

• Decision to perform ERCP taken intraoperatively
• Intolerance/allergy against NSAID
• Patients taking NSAID daily
• Severe cardiac fail (ASA\>4)
• Kidney failure (GFR\<30 ml/min)
• Coagulation disorder
• History of peptic ulcer bleeding
• History of abdominoperineal resection
• Pregnancy
• Patients who do not understand Swedish

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator

MeSH Terms

Conditions

Common Bile Duct Diseases; Pancreatitis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Pancreatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Gabriel Sandblom, Ass Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Sandblom, Ass Prof

CONTACT

+46704158218; gabriel.sandblom@ki.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior Consultant

Model Details: Open label randomised controlled trial of Diclofenac as prophylaxis versus no prophylaxis for prevention of post-ERCP pancreatitis

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 23, 2018
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08