Scleroligation for Eradication of Gastroesophageal Varices.

NCT ID: NCT02646202

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.

Conditions

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Gastroesophageal Varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sclerotherapy group

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

Group Type ACTIVE_COMPARATOR

Sclerotherapy

Intervention Type PROCEDURE

Injection of varices

Endoscopic band ligation group

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

Group Type ACTIVE_COMPARATOR

Band ligation

Intervention Type PROCEDURE

endoscopic banding of varices

Sclero-ligation (SL) group

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

Group Type EXPERIMENTAL

Scleroligation

Intervention Type PROCEDURE

intra variceal endoscopic sclerotherapy combined with band ligation.

Interventions

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Sclerotherapy

Injection of varices

Intervention Type PROCEDURE

Band ligation

endoscopic banding of varices

Intervention Type PROCEDURE

Scleroligation

intra variceal endoscopic sclerotherapy combined with band ligation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ferial El-kalla, Professor

Role: PRINCIPAL_INVESTIGATOR

Head of endoscopy unit - Tropical medicine department- Tanta

Mohamed Elhendawy, Consultant

Role: PRINCIPAL_INVESTIGATOR

liver diseases dept.- Tanta university hospital

Loai Mansour, Consultant

Role: STUDY_DIRECTOR

liver diseases dept.-Tanta university hospital

Abdelrahman kobtan, Consultant

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Rehab Badawy, Consultant

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Hanan Elbasat, Professor

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Sherief Abd-Elsalam, Consultant

Role: STUDY_CHAIR

Liver diseases and gastroenterology dept.-Tanta university hospital

Locations

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Tropical medicine dept.-Tanta university hospital

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief M. Abd-Elsalam, Consultant

Role: CONTACT

Phone: 00201095159522

Email: [email protected]

Facility Contacts

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Sherief Abd-Elsalam

Role: primary

References

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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.

Reference Type DERIVED
PMID: 28082116 (View on PubMed)

Other Identifiers

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Scleroligation

Identifier Type: -

Identifier Source: org_study_id