Endoscopic sclerotherapy compared with no specific treatment for the primary prevention of bleeding from oesophageal varices: a randomised controlled multicentre trial
| ISRCTN | ISRCTN03215899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03215899 |
| Secondary identifying numbers | 90/006 |
- Submission date
- 06/08/2003
- Registration date
- 13/08/2003
- Last edited
- 18/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Henk R. van Buuren
Scientific
Scientific
Erasmus MC
University Medical Centre Rotterdam
PO BOX 3000
Rotterdam
2040 CA
Netherlands
| Phone | +31 (0)10 463 3041 |
|---|---|
| h.vanbuuren@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To compare endoscopic sclerotherapy (ES) with no specific treatment for the primary prevention of bleeding from oesophageal varices in patients with cirrhosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Liver cirrhosis |
| Intervention | Prophylactic sclerotherapy versus no specific treatment. For more information, please contact the College voor Zorgverzekeringen (Health Care Insurance Board) on infoSBA@cvz.nl. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/1986 |
| Completion date | 31/05/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 166 |
| Key inclusion criteria | 1. Adults with endoscopically documented grade II, III or IV oesophageal varices 2. Absence of prior bleeding from varices 3. Evidence of active and/or progressive liver disease (e.g. as indicated by repeatedly elevated serum transaminases or increasing serum bilirubin levels or development of ascites within the past year) 4. Documented increase in the size of oesophageal varices 5. All patients gave informed consent |
| Key exclusion criteria | 1. Use of beta-blockers and nitrates 2. Malignancy 3. Haemophilia 4. Age older than 70 - 75 years 5. No opportunity for follow-up visits |
| Date of first enrolment | 01/05/1986 |
| Date of final enrolment | 31/05/1993 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC
Rotterdam
2040 CA
Netherlands
2040 CA
Netherlands
Sponsor information
Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (The Netherlands)
Government
Government
PO Box 320
Diemen
1110 AH
Netherlands
| Phone | +31 (0)20 7978555 |
|---|---|
| Info@cvz.nl |
Funders
Funder type
Government
Dutch Health Care Insurance Board (College Voor Zorgverzekeringen) (The Netherlands) (ref: OG 90/006)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 15/08/2003 | Yes | No |
