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Diclofenac for Prevention of Post-ERC Pancreatitis

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

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 23, 2018
Last Update Posted Date July 23, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diclofenac for Prevention of Post-ERC Pancreatitis
Official Title  ICMJE Diclofenac for Prevention of Post-ERC Pancreatitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Common Bile Duct Diseases
Intervention  ICMJE Drug: Diclofenac
Diclofenac rectally given before the ERCP to prevent pancreatitis
Study Arms  ICMJE
  • Active Comparator: Diclofenac
    100 mg Diclofenac rectally prior to the ERCP
    Intervention: Drug: Diclofenac
  • No Intervention: No prophylaxis
    No prophylaxis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabriel Sandblom, Ass Prof +46704158218 gabriel.sandblom@ki.se
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03595150
Other Study ID Numbers  ICMJE Post-ERCP-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gabriel Sandblom, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Uppsala University
Investigators  ICMJE
Principal Investigator: Gabriel Sandblom, Ass Prof Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP