The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed
Information source: Aga Khan University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Portal Hypertension; Cirrhosis; Hematemesis; Melena
Intervention: Terlipressin (Drug); Octreotide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Aga Khan University Official(s) and/or principal investigator(s):
Shahab Abid, FCPS, FACG, Principal Investigator, Affiliation: The Aga Khan University
Wasim Jafri, FRCP, FACG, Study Director, Affiliation: The Aga Khan University
Saeed S Hamid, FRCP, FACG, Study Director, Affiliation: The Aga Khan University
Salih Mohammad, FCPS; MACG, Study Director, Affiliation: The Aga Khan University
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).
Clinical Details
Official title: Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety & Efficacy
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
The Aga Khan University Hospital, Karachi, Sindh 74800, Pakistan
Additional Information
Starting date: May 2004
Ending date: July 2005
Last updated: December 4, 2007
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