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Variceal band ligation for primary prophylaxis

A multicentre randomised variceal band ligation for primary prophylaxis of oesophageal variceal bleeding in childhood portal hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78678155
Enrollment
200
Registered
2010-05-12
Start date
2006-03-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Oral and Gastrointestinal

Interventions

Children will be randomised to: 1. Prophylactic band ligation: Ligation will be carried out under anaesthesia according to local practice using a multiband ligator. Bands will be applied to all varic
2 - 12 years, 500 mg
greater than 12 years, 1 g). Other antiacid treatment will be according to local practice. Endoscopy will be repeated after 3 months and at 6 monthly intervals until all varices are ablated or decrea

Sponsors

British Society of Paediatric Gastroenterology Hepatology and Nutrition (BSPGHAN) (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. Other causes of gastrointestinal bleeding 2. Death due to variceal bleeding

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026