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

Aga Khan University320 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

320

Conditions

Portal Hypertension Cirrhosis Hematemesis Melena

Interventions

TerlipressinDRUG

2 mg stat \& then 1 mg q6h iv and Placebo of Octreotide

OctreotideDRUG

Octreotide 50mcg/hr infusion \& a placebo of Terlipressin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Aga Khan University Hospital

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Safety & Efficacy

Time frame: 5 days

Data from ClinicalTrials.gov

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