Condition category
Digestive System
Date applied
06/08/2003
Date assigned
13/08/2003
Last edited
18/07/2008
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 Henk R. van Buuren

ORCID ID

Contact details

Erasmus MC
University Medical Centre Rotterdam
PO BOX 3000
Rotterdam
2040 CA
Netherlands
+31 (0)10 463 3041
h.vanbuuren@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

90/006

Study information

Scientific title

Acronym

Study hypothesis

To compare endoscopic sclerotherapy (ES) with no specific treatment for the primary prevention of bleeding from oesophageal varices in patients with cirrhosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1986

Overall trial end date

31/05/1993

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

166

Participant 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

Recruitment start date

01/05/1986

Recruitment end date

31/05/1993

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC
Rotterdam
2040 CA
Netherlands

Sponsor information

Organisation

Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (The Netherlands)

Sponsor details

PO Box 320
Diemen
1110 AH
Netherlands
+31 (0)20 7978555
Info@cvz.nl

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Dutch Health Care Insurance Board (College Voor Zorgverzekeringen) (The Netherlands) (ref: OG 90/006)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results on http://www.ncbi.nlm.nih.gov/pubmed/12919638

Publication citations

  1. Results

    van Buuren HR, Rasch MC, Batenburg PL, Bolwerk CJ, Nicolai JJ, van der Werf SD, Scherpenisse J, Arends LR, van Hattum J, Rauws EA, Schalm SW, Endoscopic sclerotherapy compared with no specific treatment for the primary prevention of bleeding from esophageal varices. A randomized controlled multicentre trial [ISRCTN03215899]., BMC Gastroenterol, 2003, 3, 22, doi: 10.1186/1471-230X-3-22.

Additional files

Editorial Notes