Condition category
Digestive System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
02/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patrick McKiernan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6427

Study information

Scientific title

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

Acronym

Study hypothesis

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

West Midlands MREC, 26/01/2006, ref: 05/MRE07/76

Study design

Multicentre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please email Mrs Carla Lloyd at carla.lloyd@bch.nhs.uk to require a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2006

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned sample size: 200

Participant 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)

Recruitment start date

01/03/2006

Recruitment end date

01/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

Administration Office
5 Woodthorpe Drive
Stourbridge
DY9 7JX
United Kingdom
-
administrator@bspghan.org.uk

Sponsor type

Research organisation

Website

http://bspghan.org.uk/

Funders

Funder type

Charity

Funder name

Children's Liver Disease Foundation (CLDF) (UK)

Alternative name(s)

CLDF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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