Scleroligation for Eradication of Gastroesophageal Varices.
Phase 3
- Conditions
- Gastroesophageal Varices
- Interventions
- Procedure: ScleroligationProcedure: Band ligationProcedure: Sclerotherapy
- Registration Number
- NCT02646202
- Lead Sponsor
- Sherief Abd-Elsalam
- 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.
- Detailed Description
Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sclero-ligation (SL) group Scleroligation thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation. Endoscopic band ligation group Band ligation thirty patients treated by endoscopic banding using the Euro-Ligator system. Sclerotherapy group Sclerotherapy thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.
- Primary Outcome Measures
Name Time Method Number of sessions to complete variceal obliteration 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tropical medicine dept.-Tanta university hospital
🇪🇬Tanta, Egypt