Scleroligation for Eradication of Gastroesophageal Varices.

Sherief Abd-Elsalam

Status and phase: Unknown; Phase 3

Conditions: Gastroesophageal Varices

Treatments: Procedure: Band ligation; Procedure: Sclerotherapy; Procedure: Scleroligation

Study type: Interventional

Funder types: Other

Identifiers

NCT02646202

Scleroligation

Details and patient eligibility

About

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.

Full description

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Sclerotherapy group

Active Comparator group

Description:

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

Treatment:

Procedure: Sclerotherapy

Endoscopic band ligation group

Active Comparator group

Description:

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

Treatment:

Procedure: Band ligation

Sclero-ligation (SL) group

Experimental group

Description:

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

Treatment:

Procedure: Scleroligation