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

Phase 4
Completed
Conditions
Portal Hypertension
Cirrhosis
Hematemesis
Melena
Interventions
Registration Number
NCT00534677
Lead Sponsor
Aga Khan University
Brief Summary

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).

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
320
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ATerlipressin-
BOctreotide-
Primary Outcome Measures
NameTimeMethod
Safety & Efficacy5 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Aga Khan University Hospital

🇵🇰

Karachi, Sindh, Pakistan

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