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NCT04049734 Clinical Trial

Oral Losartan in Prevention of Post-ERCP Paancreatitis

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:
Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04049734
Other study ID # 689
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2015
Est. completion date March 2017

Study information
Verified date August 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• oral losatan
50 mg of oral losartan one hour before the ERCP once

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with development of acute pancreatitis Number of participants with development of abdominal pain and elevated serum amylase and/or lipase 24 hours
See also
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