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Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

Primary Purpose

Hematemesis, Portal Hypertension

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Endoscopic control of hematemesis

About this trial

This is an interventional treatment trial for Hematemesis focused on measuring esophageal varices, hematemesis, endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Active hematemesis
esophageal varices

Exclusion Criteria:

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

Sites / Locations

Hematemesis unit, Alexandria Main University Hospital, Azarita

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

band ligation group

sclerotherapy group

Arm Description

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

This group will have immediate control of hematemesis by endoscopic sclerotherapy

Outcomes

Primary Outcome Measures

control of hematemesis

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

Secondary Outcome Measures

occurence of complications from the intervention

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

Full Information

NCT ID

NCT01131962

First Posted

May 26, 2010

Last Updated

December 3, 2014

Sponsor

University of Alexandria

1. Study Identification

Unique Protocol Identification Number

NCT01131962

Brief Title

Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alexandria

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematemesis, Portal Hypertension

Keywords

esophageal varices, hematemesis, endoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

band ligation group

Arm Type

Active Comparator

Arm Description

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

Arm Title

sclerotherapy group

Arm Type

Active Comparator

Arm Description

This group will have immediate control of hematemesis by endoscopic sclerotherapy

Intervention Type

Procedure

Intervention Name(s)

Endoscopic control of hematemesis

Other Intervention Name(s)

Six shooter band ligator, Ehanolamine oleate sclerosant material

Intervention Description

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

Primary Outcome Measure Information:

Title

control of hematemesis

Description

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

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

occurence of complications from the intervention

Description

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Active hematemesis esophageal varices Exclusion Criteria: Hemodynamic unstability Hepatic coma or precoma Tense ascitis Coagulopathies concomitant gastric varices

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasser Hamza, A Prof

Organizational Affiliation

University of Alexandria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hematemesis unit, Alexandria Main University Hospital, Azarita

City

Alexandria

Country

Egypt

12. IPD Sharing Statement

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Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

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