Diclofenac for Prevention of Post-ERC Pancreatitis
Primary Purpose
Common Bile Duct Diseases
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Diclofenac
Sponsored by
About this trial
This is an interventional prevention trial for Common Bile Duct Diseases focused on measuring Endoscopic Retrograde Cholangiopancreatography, Pancreatitis, Diclofenac
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Diclofenac
No prophylaxis
Arm Description
100 mg Diclofenac rectally prior to the ERCP
No prophylaxis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adverse drug reactions
Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding
Mortality
Death within 30 days after ERCP
Full Information
NCT ID
NCT03595150
First Posted
June 28, 2018
Last Updated
March 1, 2023
Sponsor
Karolinska Institutet
Collaborators
Uppsala University
1. Study Identification
Unique Protocol Identification Number
NCT03595150
Brief Title
Diclofenac for Prevention of Post-ERC Pancreatitis
Official Title
Diclofenac for Prevention of Post-ERC Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Uppsala University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Diseases
Keywords
Endoscopic Retrograde Cholangiopancreatography, Pancreatitis, Diclofenac
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open label randomised controlled trial of Diclofenac as prophylaxis versus no prophylaxis for prevention of post-ERCP pancreatitis
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Description
100 mg Diclofenac rectally prior to the ERCP
Arm Title
No prophylaxis
Arm Type
No Intervention
Arm Description
No prophylaxis
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
Diclofenac rectally given before the ERCP to prevent pancreatitis
Primary Outcome Measure Information:
Title
Post-ERCP pancreatitis
Description
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.
Time Frame
Within 30 days post-ERCP
Secondary Outcome Measure Information:
Title
Adverse drug reactions
Description
Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding
Time Frame
Within 30 days post-ERCP
Title
Mortality
Description
Death within 30 days after ERCP
Time Frame
Within 30 days post-ERCP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Sandblom, Ass Prof
Phone
+46704158218
Email
gabriel.sandblom@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Sandblom, Ass Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Diclofenac for Prevention of Post-ERC Pancreatitis
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