Condition category
Digestive System
Date applied
26/01/2006
Date assigned
22/03/2006
Last edited
20/09/2007
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

Prof Tilman Sauerbruch

ORCID ID

Contact details

Sigmund-Freud-Str. 25
Bonn
53105
Germany
+49 (0)228 287 5216
sauerbruch@uni-bonn.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SA-388-4-1

Study information

Scientific title

Acronym

Study hypothesis

The objective of this trial is to show that an intrahepatic shunt by insertion of a small-diameter polytetrafluoroethylene (PTFE) covered stent (cTIPS) is the superior method for secondary prevention of variceal bleeding in cirrhosis when compared to an optimised standard treatment that includes hemodynamically monitored drug treatment (propranolol and isosorbide-5-mononitrate [IsMn]) or endoscopic banding ligation in haemodynamic non-responders.

Ethics approval

Ethics approval received from the Ethical Committee of the University of Bonn on the 23rd January 2006 (ref: 110/05).

Study design

Randomised, controlled, open multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Liver cirrhosis

Intervention

PTFE-coated TIPS versus optimized medical treatment including drug treatment with propanolol and isosorbide-5-mononitrate with or without ligation

Intervention type

Drug

Phase

Not Specified

Drug names

Propanolol, isosorbide-5-mononitrate

Primary outcome measures

Re-bleeding incidence.

Secondary outcome measures

1. Overall survival
2. Safety
3. Quality of life
4. Direct and indirect costs

Overall trial start date

01/03/2006

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Liver cirrhosis (histological or clinical diagnosis)
2. Child-Pugh score less than 12
3. Serum bilirubin less than 3 mg/dl
4. Significant variceal bleeding greater than 5 days prior to randomisation
5. Clinical indication for re-bleeding prophylaxis (i.e. presence of esophageal varices greater than or equal to grade 2)
6. Age 18 to 75 years
7. Written informed consent signed and dated by patient and investigator

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

186 (93 per group)

Participant exclusion criteria

1. Overt hepatic encephalopathy independent from bleeding
2. Pre-hepatic portal hypertension
3. Type II gastric varices as exclusive bleeding site
4. Established chronic drug treatment with beta-blockers and/or nitrates against portal hypertension
5. Listing for liver transplantation on T2 status
6. Existing porto-systemic shunt (TIPS or surgical shunt)
7. Heart failure according to the New York Heart Association (NYHA) classification greater than 2 or ejection fraction less than 40%
8. Contraindication against propanolol or nitrates
9. Platelet count less than 30 g/l, prothrombin index less than 30%, disseminated intravascular coagulation
10. Advanced malignancy or severe infection
11. Females of child bearing potential not using a safe contraceptive measure during the study or females with a positive pregnancy test prior to study or nursing women

Recruitment start date

01/03/2006

Recruitment end date

01/09/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Sigmund-Freud-Str. 25
Bonn
53105
Germany

Sponsor information

Organisation

Individual sponsor (Germany)

Sponsor details

Prof Dr Büttner
Dean of the Medical Faculty
University of Bonn
Sigmund-Freud-Str. 25
Bonn
53127
Germany
+49 (0)228 287 9200
med-deka@ukb.uni-bonn.de

Sponsor type

Research organisation

Website

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: DFG-AZ 60665-02-2/401/04)

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