Diclofenac for Prevention of Post-ERC Pancreatitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Common Bile Duct Diseases
• Intervention / Treatment: Drug: Diclofenac

Detailed Description

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a procedure commonly performed for diagnosing changes in the bile ducts or managing outflow obstruction. Although ERCP may in most cases be performed safely, there is a risk of developing acute pancreatitis following the procedure. The risk has been estimated to 5-10%, with an increased risk in women, younger patients and in case the cannulation is difficult.

Phospholipase 2 is crucial in the pathogenesis of acute pancreatitis. As Diclofenac is a potent inhibitor of Phospholipase 2, it has been suggested that it may be used for prevention of post-ERCP pancreatitis. There is some evidence for the effectiveness of Diclofenac, but more studies are needed to confirm that it reduces the risk of post-ERCP pancreatitis.

In order to test whether Diclofenac reduces the risk for post-ERCP pancreatitis, a register-based randomized controlled study is planned. The study will be conducted embedded in the Swedish Register for Gallstone Surgery and ERCP (GallRiks). GallRiks includes data corresponding to the eligibility criteria as well as outcome measures. GallRiks will also be used to record which patients have been screened for inclusion.

Patients who meet the eligibility criteria are invited to the study. If they accept inclusion, they are randomized to 100 mg Diclofenac prior to the ERCP or np prophylaxis. No blinding is done.

The aim is to include 1000 patients. When 500 patients have been included, an interim analysis will be performed, comparing the incidence of pancreatitis and mortality in the two groups. A retrospective review of the patient records will be performed for those who develop pancreatitis.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Gabriel Sandblom, Ass Prof; Phone Number: +46704158218; Email: gabriel.sandblom@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing ERCP

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diclofenac; 100 mg Diclofenac rectally prior to the ERCP	Drug: Diclofenac; Diclofenac rectally given before the ERCP to prevent pancreatitis
No Intervention: No prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug reactions	Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding	Within 30 days post-ERCP
Mortality	Death within 30 days after ERCP	Within 30 days post-ERCP

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Gabriel Sandblom, Ass Prof, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Diclofenac; Pancreatitis; Endoscopic Retrograde Cholangiopancreatography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Biliary Tract Diseases; Pancreatitis; Bile Duct Diseases; Common Bile Duct Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: Post-ERCP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No