Clinical Trials Directory

Trials / Completed

CompletedNCT00888784

Secondary Prophylaxis Gastric Variceal Bleed

Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Govind Ballabh Pant Hospital · Other Government
Sex
All
Age
10 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic Cyanoacrylate injectionEndoscopic Cyanoacrylate injection in gastric varix
DRUGbeta-blocker (propranolol)Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \>90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \<90 mm Hg or pulse rate \<55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.

Timeline

Start date
2006-08-01
Primary completion
2009-01-01
Completion
2009-01-01
First posted
2009-04-28
Last updated
2009-04-28

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT00888784. Inclusion in this directory is not an endorsement.