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Diclofenac for Prevention of Post-ERC Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03595150
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : March 1, 2021
Uppsala University
Information provided by (Responsible Party):
Gabriel Sandblom, Karolinska Institutet

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.

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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 : September 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03595150

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Contact: Gabriel Sandblom, Ass Prof +46704158218

Sponsors and Collaborators
Karolinska Institutet
Uppsala University
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Principal Investigator: Gabriel Sandblom, Ass Prof Karolinska Institutet
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Responsible Party: Gabriel Sandblom, Associate Professor, Senior Consultant, Karolinska Institutet Identifier: NCT03595150    
Other Study ID Numbers: Post-ERCP-01
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Bile Duct Diseases
Common Bile Duct Diseases
Pancreatic Diseases
Digestive System Diseases
Biliary Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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