Oral Losartan in Prevention of Post-ERCP Paancreatitis

August 8, 2019 updated by: Shereen Abou Bakr Saleh, Ain Shams University

Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients received the oral losartan
50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis
Drug: oral losatan
50 mg of oral losartan one hour before the ERCP once
No Intervention: patients didn't receive the oral losartan
50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with development of acute pancreatitis
Time Frame: 24 hours
Number of participants with development of abdominal pain and elevated serum amylase and/or lipase
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 3, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 689

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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