Oral Losartan in Prevention of Post-ERCP Paancreatitis

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Drug: oral losatan

Study type: Interventional

Funder types: Other

Identifiers

NCT04049734

689

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

patients received the oral losartan

Active Comparator group

Description:

50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis

Treatment:

Drug: oral losatan

patients didn't receive the oral losartan

No Intervention group

Description:

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