CompletedNCT04049734Updated Aug 9, 2019

Oral Losartan in Prevention of Post-ERCP Paancreatitis

A Phase 1 interventional study of oral losatan in Post-ERCP Acute Pancreatitis, sponsored by Ain Shams University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-09.

Sponsored by Ain Shams University · Phase 1, Interventional, and Prevention

From the registry’s dates

Registered 4 years 7 months after the study started (first participant enrolled Jan 2015, registered Aug 2019).

Phase: Phase 1
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Post-ERCP Acute Pancreatitis

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Pancreatitis 752

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.

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Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 100 participants (actual)

Study arms

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
No intervention
patients didn't receive the oral losartan
50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs

Interventions

Drugoral losatan
50 mg of oral losartan one hour before the ERCP once

What researchers measure

Primary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04049734
Lead sponsor: Ain Shams University
Responsible party: Shereen Abou Bakr Saleh (Assistant Professor, Ain Shams University) — Principal investigator
First posted: Aug 8, 2019
Start date: Jan 2015
Primary completion: Jan 2017
Completion: Mar 2017
Last update: Aug 9, 2019

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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