The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Aga Khan University

Status and phase: Completed; Phase 4

Conditions: Melena; Portal Hypertension; Cirrhosis; Hematemesis

Treatments: Drug: Octreotide; Drug: Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT00534677

297-Med/ERC-04

Details and patient eligibility

About

Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).

Full description

The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).

This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age

Exclusion criteria

• Ulcerative esophagitis,
• Mallory Weiss tear,
• Bleeding gastric or duodenal ulcers,
• Bleeding from gastric varices or portal hypertensive gastropathy and
• Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Terlipressin

B

Active Comparator group

Treatment:

Drug: Octreotide