Diclofenac for Prevention of Post-ERC Pancreatitis
ConditionCommon Bile Duct Diseases
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing ERCP
Disqualifiers
Decision to perform ERCP taken intraoperatively
Intolerance/allergy against NSAID
Patients taking NSAID daily
Severe cardiac fail (ASA>4)
Trial design
Design model
Parallel
Treatments tested in this trial
Diclofenac
DrugDiclofenac rectally given before the ERCP to prevent pancreatitis
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: DiclofenacActive comparator 1 intervention
Group B: No prophylaxisNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 30 days post-ERCPSecondary outcomes
1
Adverse drug reactions
Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding
Time frame
Within 30 days post-ERCP2
Mortality
Death within 30 days after ERCP
Time frame
Within 30 days post-ERCPLocations
Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Uppsala University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: