Variceal band ligation for primary prophylaxis
| ISRCTN | ISRCTN78678155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78678155 |
| Protocol serial number | 6427 |
| Sponsor | British Society of Paediatric Gastroenterology Hepatology and Nutrition (BSPGHAN) (UK) |
| Funder | Children's Liver Disease Foundation (CLDF) (UK) |
- 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
Scientific
Birmingham Children's Hospital
Liver Unit
Birmingham
B4 6NH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional prevention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Oesophageal variceal haemorrhage, defined as malena and/or haematemesis together with either: |
| Key secondary outcome measure(s) |
1. Other causes of gastrointestinal bleeding |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
B4 6NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/08/2016: No publications found, verifying study status with principal investigator.
