PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES?

NCT01893541 | Completed Phase 4 DMC

• 1 other identifier: DBONILHA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CIRRHOSIS; ESOPHAGEAL VARICES

Keywords

CIRRHOTIC; VARICEAL BLEEDING; PRIMARY PROPHYLAXIS

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be esophageal varices recurrence

  Esophageal varices recurrence will be defined as the reappearance of uninterrupted EV of any caliber, with or without red color signs in patients in which varices had been eradicated.

  Two years

Secondary Outcomes (1)

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

  two years

Study Arms (2)

EBL PLUS PROPRANOLOL

ACTIVE COMPARATOR

The EBL procedures will be performed using standard technique with a multiband ligation device. Elastic bands will be placed according to physician decision, starting at esophagogastric junction. Endoscopic band ligation sessions will be repeated at intervals of 3 to 4 weeks until all varices were obliterated. The initial propranolol dose will be orally BID 40 mg, irrespective of patient's weight. The objective of the administration of propranolol will be induce beta-adrenergic blockade evaluated by reduction in heart rate to 55 bpm or a 25% drop in baseline heart rate. A baseline electrocardiogram will be obtained from all patients. The doses will be adjusted during weekly visits until beta-adrenergic blockade. After the adequate dose will be reached, the visits will be scheduled monthly during the first 3 months (until EV eradication) and then at a 3-month interval until the end of follow-up.

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

ENDOSCOPIC BAND LIGATION

ACTIVE COMPARATOR

The procedures will be performed using standard technique with a multiband ligation device. Elastic bands will be placed according to physician decision, starting at esophagogastric junction. All varices will be treated during the same session. Endoscopic band ligation sessions will be repeated at intervals of 3 to 4 weeks until all varices will be obliterated.

Procedure: ENDOSCOPIC BAND LIGATION

Interventions

ENDOSCOPIC BAND LIGATION PROCEDURE

The procedures will be performed using standard technique with a multiband ligation device. Elastic bands will be placed according to physician decision, starting at esophagogastric junction. All varices will be treated during the same session. Endoscopic band ligation sessions will be repeated at intervals of 3 to 4 weeks until all varices will be obliterated.

EBL PLUS PROPRANOLOL; ENDOSCOPIC BAND LIGATION

PROPRANOLOL DRUG

The initial propranolol dose will be orally BID 40 mg, irrespective of patient's weight. The objective of the administration of propranolol will be induce beta-adrenergic blockade evaluated by reduction in heart rate to 55 bpm or a 25% drop in baseline heart rate. A baseline electrocardiogram will be obtained from all patients. The doses will be adjusted during weekly visits until beta-adrenergic blockade. After the adequate dose will be reached, the visits will be scheduled monthly during the first 3 months (until EV eradication) and then at a 3-month interval until the end of follow-up.

EBL PLUS PROPRANOLOL

a multiband ligation device DEVICE

EBL PLUS PROPRANOLOL

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis with esophageal varices
• Age between 18 and 78 years
• Accept to participate

You may not qualify if:

• Portal hypertension by schistosomiasis
• Contraindications for propranolol use
• Do not accept to participate

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Fibrosis; Esophageal and Gastric Varices

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Danielle Q Bonilha, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: July 9, 2013
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

BR (1)