NCT01131962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

3.3 years

First QC Date

May 26, 2010

Last Update Submit

December 3, 2014

Conditions

HematemesisPortal Hypertension

Keywords

esophageal variceshematemesisendoscopy

Outcome Measures

Primary Outcomes (1)

  • control of hematemesis

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

    72 hours

Secondary Outcomes (1)

  • occurence of complications from the intervention

    30 days

Study Arms (2)

band ligation group

ACTIVE COMPARATOR

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

Procedure: Endoscopic control of hematemesis

sclerotherapy group

ACTIVE COMPARATOR

This group will have immediate control of hematemesis by endoscopic sclerotherapy

Procedure: Endoscopic control of hematemesis

Interventions

Endoscopic control of hematemesisPROCEDURE

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

Also known as: Six shooter band ligator, Ehanolamine oleate sclerosant material
band ligation groupsclerotherapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active hematemesis
  • esophageal varices

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematemesis unit, Alexandria Main University Hospital, Azarita

Alexandria, Egypt

Location

MeSH Terms

Conditions

HematemesisHypertension, PortalEsophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsVomitingSigns and Symptoms, DigestiveSigns and SymptomsLiver DiseasesEsophageal Diseases

Study Officials

  • Yasser Hamza, A Prof

    University of Alexandria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Study Start

May 1, 2008

Primary Completion

September 1, 2011

Study Completion

July 1, 2012

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

EG(1)