Condition category
Digestive System
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
21/09/2007
Prospective/Retrospective
Prospectively 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 F.H.D. Sebus

ORCID ID

Contact details

Erasmus Medical Centre
Department of Radiology
’s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 4632277
f.sebus@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Transjugular Intrahepatic Porto-systemic Shunt (TIPS) using covered stents will be equally or more effective, cost-effective and safe as/safer than endoscopic treatment in the secondary prevention of gastro-oesophageal variceal bleeding.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, multicentre, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Gastro-oesophageal variceal bleeding

Intervention

Transjugular Intrahepatic Porto-systemic Shunt (TIPS)(intervention group):
A shunt is made between the portal vein and the systemic veins, which decreases blood pressure in the portal vein to normal. This decreases the risk of re-bleeding. The procedure takes approximately two hours.

Endoscopic treatment (control group):
The bleeding varices are ligated or sclerosed. The pressure in the portal vein remains too high. This procedure has to be repeated several times until the varices are completely obliterated.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Recurrence of variceal bleeding

Secondary outcome measures

1. Occurrence of treatment failure (either switch to other therapy -“cross-over”- or death)
2. Incidence of encephalopathy, defined as occurrence of grade II, III or IV encephalopathy
3. Liver function (according to Child-Pugh class)
4. Mortality
5. Quality of life
6. Costs

Overall trial start date

01/06/2007

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients presenting with a first or second episode of oesophageal or gastric variceal bleeding, as documented by endoscopy and meeting accepted diagnostic criteria
2. Initial stabilisation (absence of evidence of continued bleeding)
3. Informed consent
4. Aged more than 18 and less than 76 years

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

124

Participant exclusion criteria

1. History of serious or refractory encephalopathy, unrelated to gastrointestinal bleeding
2. History of significant heart failure (New York Heart Association [NYHA] class III & IV)
3. Portal hypertension due to other causes than liver disease (e.g. portal vein or splenic vein thrombosis)
4. Previous TIPS placement
5. Advanced hepatocellular carcinoma
6. Severely compromised liver function (Child-Pugh score greater than 13)
7. Sepsis and/or multiorgan failure

Recruitment start date

01/06/2007

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3015 CE
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Radiology
Dr. Molewaterplein 50
Rotterdam
3015 GE
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm#http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

Publication citations

Additional files

Editorial Notes