NCT02646202

Brief Summary

Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

6.9 years

First QC Date

January 1, 2016

Last Update Submit

December 22, 2017

Conditions

Gastroesophageal Varices

Outcome Measures

Primary Outcomes (1)

  • Number of sessions to complete variceal obliteration

    1 year

Study Arms (3)

Sclerotherapy group

ACTIVE COMPARATOR

thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.

Procedure: Sclerotherapy

Endoscopic band ligation group

ACTIVE COMPARATOR

thirty patients treated by endoscopic banding using the Euro-Ligator system.

Procedure: Band ligation

Sclero-ligation (SL) group

EXPERIMENTAL

thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation.

Procedure: Scleroligation

Interventions

SclerotherapyPROCEDURE

Injection of varices

Sclerotherapy group
Band ligationPROCEDURE

endoscopic banding of varices

Endoscopic band ligation group
ScleroligationPROCEDURE

intra variceal endoscopic sclerotherapy combined with band ligation.

Sclero-ligation (SL) group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.

You may not qualify if:

  • Patients were excluded if they had malignancy of any origin.
  • Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
  • Other potential causes of GIT bleeding.
  • Patients with previous endoscopic or surgical intervention for varices were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical medicine dept.-Tanta university hospital

Tanta, Egypt

RECRUITING

Related Publications (1)

  • Mansour L, El-Kalla F, El-Bassat H, Abd-Elsalam S, El-Bedewy M, Kobtan A, Badawi R, Elhendawy M. Randomized controlled trial of scleroligation versus band ligation alone for eradication of gastroesophageal varices. Gastrointest Endosc. 2017 Aug;86(2):307-315. doi: 10.1016/j.gie.2016.12.026. Epub 2017 Jan 9.

    PMID: 28082116DERIVED

MeSH Terms

Interventions

Sclerotherapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Ferial El-kalla, Professor

    Head of endoscopy unit - Tropical medicine department- Tanta

    PRINCIPAL INVESTIGATOR

  • Mohamed Elhendawy, Consultant

    liver diseases dept.- Tanta university hospital

    PRINCIPAL INVESTIGATOR

  • Loai Mansour, Consultant

    liver diseases dept.-Tanta university hospital

    STUDY DIRECTOR

  • Abdelrahman kobtan, Consultant

    liver diseases dept.-Tanta university hospital

    STUDY CHAIR

  • Rehab Badawy, Consultant

    liver diseases dept.-Tanta university hospital

    STUDY CHAIR

  • Hanan Elbasat, Professor

    liver diseases dept.-Tanta university hospital

    STUDY CHAIR

  • Sherief Abd-Elsalam, Consultant

    Liver diseases and gastroenterology dept.-Tanta university hospital

    STUDY CHAIR

Central Study Contacts

Sherief M. Abd-Elsalam, Consultant

CONTACT

00201095159522sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant liver and GIT diseases- Tanta university hospital

Study Record Dates

First Submitted

January 1, 2016

First Posted

January 5, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 27, 2017

Record last verified: 2017-12

Locations

EG(1)