Variceal band ligation for primary prophylaxis

Completed

• Conditions: Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal; Digestive System; Childhood portal hypertension

• Registration Number: ISRCTN78678155
• Lead Sponsor: British Society of Paediatric Gastroenterology Hepatology and Nutrition (BSPGHAN) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-12
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged less than or equal to 16 years, either sex
2. Large oesophageal varices
3. No previous variceal bleed
4. Variceal band ligation feasible

Exclusion Criteria

1. Previous endoscopic treatment for portal hypertension
2. Drug treatment for portal hypertension within previous 3 months
3. Anticipated need for liver transplantation or surgery for portal hypertension within 3 months
4. Presence of severe coagulopathy (international normalised ratio [INR] greater than 2.5 and/or platelets less than 50 x 10^9/L)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oesophageal variceal haemorrhage, defined as malena and/or haematemesis together with either:<br>1. Endoscopic visualization of blood emanating from oesophageal varices, or<br>2. The presence of varices together with blood in the stomach and no other source of identifiable bleeding

Secondary Outcome Measures

Name	Time	Method
1. Other causes of gastrointestinal bleeding<br>2. Death due to variceal bleeding