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PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES?

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: CIRRHOSIS; ESOPHAGEAL VARICES

Intervention: ENDOSCOPIC BAND LIGATION (Procedure); PROPRANOLOL (Drug); a multiband ligation device (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Danielle Q Bonilha, MD, Principal Investigator, Affiliation: Federal University of São Paulo

Summary

This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patients with high-risk varices.

Clinical Details

Official title: PROPRANOLOL ASSOCIATED WITH ENDOSCOPIC BAND LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES FOR PRIMARY PROPHYLAXIS OF VARICEAL BLEEDING?: A RANDOMIZED CONTROLLED TRIAL

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: The primary outcome of this study will be esophageal varices recurrence

Secondary outcome: The secondary outcomes of this study will be variceal eradication, bleeding before eradication, mortality and complications.

Detailed description: BACKGROUND AND AIMS Bleeding from esophagogastric varices (EV) is a major complication of portal hypertension. Beta-blockers are a well-established cornerstone of portal hypertension treatment. Band ligation is the best endoscopic treatment to prevent EV bleeding. The exact benefit of beta-blocker association to band ligation remains to be defined, especially for primary prophylaxis. This prospective randomized controlled trial will compare EBL with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patients with high-risk varices. PATIENTS AND METHODS: The patients with high-risk varices will be randomly allocated to EBL plus propranolol (Group I) or EBL alone (Group II). EBL will be performed at 3-week interval till obliteration of varices. In Group I, incremental dosage of propranolol (sufficient to reduce heart rate to 55 beats/min or 25% reduction from baseline) will be administered and will be continued after obliteration of varices until the end of the study. The follow-up of patients will be 2 years. The primary outcome of this study will be EV recurrence during two years of follow-up. The secondary outcomes will be EV eradication, bleeding before eradication, mortality and complications during the same follow-up.

Eligibility

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Liver cirrhosis with esophageal varices

- Age between 18 and 78 years

- Accept to participate

Exclusion Criteria:

- Portal hypertension by schistosomiasis

- Contraindications for propranolol use

- Do not accept to participate

Locations and Contacts

Federal University of São Paulo, São Paulo 04024-002, Brazil
Additional Information

Starting date: June 2008
Last updated: July 8, 2013

Page last updated: August 23, 2015

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