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Completed

NCT Number: NCT01131962

Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

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.

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Key information

Conditions

Hematemesis Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hematemesis unit, Alexandria Main University Hospital, Azarita

Alexandria, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active hematemesis
  • esophageal varices

Exclusion criteria

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

Treatment and study plan

Endoscopic control of hematemesis

Procedure

Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy

Other names: Six shooter band ligator, Ehanolamine oleate sclerosant material

Primary outcomes

  1. control of hematemesis

    Time frame: 72 hours

    Success for either techniques to be able to stop the bleeding promptly and maintain that for 72 hours

Secondary outcomes

  1. occurence of complications from the intervention

    Time frame: 30 days

    the study subjects are reveiwed in 30 days to detect any complications secondary to the endoscopic intervention.

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Control of Acute Variceal Bleeding Using the Multi-shooter Band Ligator Compared to Injection Sclerotherapy.

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
May 27, 2010
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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