Diclofenac for Prevention of Post-ERC Pancreatitis

• ClinicalTrials.gov Identifier: NCT03595150
• Recruitment Status: Not yet recruiting
• First Posted: July 23, 2018
• Last Update Posted: September 2, 2020
• Sponsor: Karolinska Institutet
• Collaborator: Uppsala University
• Information provided by (Responsible Party): Gabriel Sandblom, Karolinska Institutet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Common Bile Duct Diseases	Drug: Diclofenac	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Open label randomised controlled trial of Diclofenac as prophylaxis versus no prophylaxis for prevention of post-ERCP pancreatitis
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Diclofenac for Prevention of Post-ERC Pancreatitis
• Estimated Study Start Date: January 1, 2021
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: March 31, 2022

Arms and Interventions

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; No prophylaxis

Outcome Measures

Primary Outcome Measures :

1. Post-ERCP pancreatitis [ Time Frame: Within 30 days post-ERCP ]
   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.

Secondary Outcome Measures :

1. Adverse drug reactions [ Time Frame: Within 30 days post-ERCP ]
   Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding
2. Mortality [ Time Frame: Within 30 days post-ERCP ]
   Death within 30 days after ERCP

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Gabriel Sandblom, Ass Prof; +46704158218; gabriel.sandblom@ki.se

Sponsors and Collaborators

Karolinska Institutet

Uppsala University

Investigators

• Principal Investigator: Gabriel Sandblom, Ass Prof; Karolinska Institutet

More Information

• Responsible Party: Gabriel Sandblom, Associate Professor, Senior Consultant, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03595150
• Other Study ID Numbers: Post-ERCP-01
• First Posted: July 23, 2018
• Last Update Posted: September 2, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Gabriel Sandblom, Karolinska Institutet:

Endoscopic Retrograde Cholangiopancreatography; Pancreatitis; Diclofenac

Additional relevant MeSH terms:

Pancreatitis; Bile Duct Diseases; Common Bile Duct Diseases; Pancreatic Diseases; Digestive System Diseases; Biliary Tract Diseases; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action