Oral Losartan in Prevention of Post-ERCP Paancreatitis

NCT ID: NCT04049734

Last Updated: 2019-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

oral losatan

Intervention Type DRUG

50 mg of oral losartan one hour before the ERCP once

patients didn't receive the oral losartan

50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oral losatan

50 mg of oral losartan one hour before the ERCP once

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Shereen Abou Bakr Saleh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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689

Identifier Type: -

Identifier Source: org_study_id

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