Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

University of Alexandria

Status and phase: Completed; Phase 3

Conditions: Portal Hypertension; Hematemesis

Treatments: Procedure: Endoscopic control of hematemesis

Study type: Interventional

Funder types: Other

Identifiers

NCT01131962

egsbl1

Details and patient eligibility

About

Band ligation and injection sclerotherapy are two modalities of treatment that are applied using the endoscope. The purpose of this study is to determine which of two methods is better for controlling bleeding from the upper gut.

Full description

The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active hematemesis
• esophageal varices

Exclusion criteria

• Hemodynamic unstability
• Hepatic coma or precoma
• Tense ascitis
• Coagulopathies
• concomitant gastric varices

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

band ligation group

Active Comparator group

Description:

this group will have immediate control of the hematemesis by endoscopic band ligation.

Treatment:

Procedure: Endoscopic control of hematemesis

sclerotherapy group

Active Comparator group

Description:

This group will have immediate control of hematemesis by endoscopic sclerotherapy

Treatment:

Procedure: Endoscopic control of hematemesis