Variceal band ligation for primary prophylaxis

ISRCTN	ISRCTN78678155
DOI	https://doi.org/10.1186/ISRCTN78678155
Secondary identifying numbers	6427

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 02/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Patrick McKiernan
Scientific

Birmingham Children's Hospital
Liver Unit
Birmingham
B4 6NH
United Kingdom

Study information

Study design	Multicentre randomised interventional prevention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please email Mrs Carla Lloyd at carla.lloyd@bch.nhs.uk to require a patient information sheet
Scientific title	A multicentre randomised variceal band ligation for primary prophylaxis of oesophageal variceal bleeding in childhood portal hypertension
Study objectives	Prophylaxis banding for oesophagael varices has been performed in children who are deemed to be at risk of bleeding. There are very little data on the use of primary prophylaxis in childhood portal hypertension. Differences in underlying pathology and baseline bleeding rates suggest that observations from adult practice should not be directly extrapolated to paediatric practice. At present there is no direct evidence to support universal primary prophylaxis for children with portal hypertension. The hypothesis is that prophylactic variceal band ligation will reduce the risk of variceal bleeding in children at significant risk of bleeding and the aim is to determine whether variceal band ligation is effective for preventing first variceal bleed in children with portal hypertension.
Ethics approval(s)	West Midlands MREC, 26/01/2006, ref: 05/MRE07/76
Health condition(s) or problem(s) studied	Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal
Intervention	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 variceal columns in the lower 5 cm of the oesophagus using up to a maximum of 6 bands. Sucralfate will be given four times a day (qds) for 5 days in age related dosing (less than 2 years, 250 mg; 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 decreased to small size. Subsequent surveillance endoscopy will be carried yearly. Recurrent varices will be treated with repeat ligation as above. 2. No prophylactic treatment: Children will be reviewed clinically after 6, 12, 18 and 24 months. Endoscopic surveillance will be according to local practice.
Intervention type	Procedure/Surgery
Primary outcome measure	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 outcome measures	1. Other causes of gastrointestinal bleeding 2. Death due to variceal bleeding
Overall study start date	01/03/2006
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	Both
Target number of participants	Planned sample size: 200
Key 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
Key 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)
Date of first enrolment	01/03/2006
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Birmingham Children's Hospital

Birmingham
B4 6NH
United Kingdom

Sponsor information

British Society of Paediatric Gastroenterology Hepatology and Nutrition (BSPGHAN) (UK)
Research organisation

Administration Office
5 Woodthorpe Drive
Stourbridge
DY9 7JX
United Kingdom

Email	administrator@bspghan.org.uk
Website	http://bspghan.org.uk/

Funders

Funder type

Charity

Children's Liver Disease Foundation (CLDF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): CLDF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

02/08/2016: No publications found, verifying study status with principal investigator.