Back to resultsOral Losartan in Prevention of Post-ERCP Paancreatitis
Primary Purpose
Post-ERCP Acute Pancreatitis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
oral losatan
Sponsored by
About this trial
This is an interventional prevention trial for Post-ERCP Acute Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Any adult patient indicated for ERCP
- Patients with obstructive jaundice.
- Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.
Exclusion Criteria:
- Patients refusing to undergo the procedure or signing the informed consent
- Patients with clinically evident acute pancreatitis before the procedure
- Patients with previous endoscopic or surgical sphincterotomy
- Patients with current use of losartan
- Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions
- Patients receiving NSAIDS within a week prior to assessment
- Patients with severe co-morbid conditions as cardiovascular disease, renal failure or decompensated liver cirrhosis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
patients received the oral losartan
patients didn't receive the oral losartan
Arm Description
50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis
50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs
Outcomes
Primary Outcome Measures
Number of participants with development of acute pancreatitis
Number of participants with development of abdominal pain and elevated serum amylase and/or lipase
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04049734
Brief Title
Oral Losartan in Prevention of Post-ERCP Paancreatitis
Official Title
Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients received the oral losartan
Arm Type
Active Comparator
Arm Description
50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis
Arm Title
patients didn't receive the oral losartan
Arm Type
No Intervention
Arm Description
50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs
Intervention Type
Drug
Intervention Name(s)
oral losatan
Intervention Description
50 mg of oral losartan one hour before the ERCP once
Primary Outcome Measure Information:
Title
Number of participants with development of acute pancreatitis
Description
Number of participants with development of abdominal pain and elevated serum amylase and/or lipase
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any adult patient indicated for ERCP
Patients with obstructive jaundice.
Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.
Exclusion Criteria:
Patients refusing to undergo the procedure or signing the informed consent
Patients with clinically evident acute pancreatitis before the procedure
Patients with previous endoscopic or surgical sphincterotomy
Patients with current use of losartan
Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions
Patients receiving NSAIDS within a week prior to assessment
Patients with severe co-morbid conditions as cardiovascular disease, renal failure or decompensated liver cirrhosis.
12. IPD Sharing Statement
Learn more about this trial
Oral Losartan in Prevention of Post-ERCP Paancreatitis
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