NCT04049734

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

August 3, 2019

Last Update Submit

August 8, 2019

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients received the oral losartan

ACTIVE COMPARATOR

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

patients didn't receive the oral losartan

NO INTERVENTION

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

Interventions

oral losatanDRUG

50 mg of oral losartan one hour before the ERCP once

patients received the oral losartan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 3, 2019

First Posted

August 8, 2019

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

August 9, 2019

Record last verified: 2019-08