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.|
|ClinicalTrials.gov Identifier: NCT03595150|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Common Bile Duct Diseases||Drug: Diclofenac||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|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)|
|Official Title:||Diclofenac for Prevention of Post-ERC Pancreatitis|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Active Comparator: Diclofenac
100 mg Diclofenac rectally prior to the ERCP
Diclofenac rectally given before the ERCP to prevent pancreatitis
No Intervention: No prophylaxis
- 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.
- Adverse drug reactions [ Time Frame: Within 30 days post-ERCP ]Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding
- Mortality [ Time Frame: Within 30 days post-ERCP ]Death within 30 days after ERCP
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 ClinicalTrials.gov identifier (NCT number): NCT03595150
|Contact: Gabriel Sandblom, Ass Proffirstname.lastname@example.org|
|Principal Investigator:||Gabriel Sandblom, Ass Prof||Karolinska Institutet|