Covered transjugular intrahepatic portosystemic stent shunt versus optimised medical treatment for the secondary prevention of variceal bleeding in cirrhosis

ISRCTN	ISRCTN16334693
DOI	https://doi.org/10.1186/ISRCTN16334693
Clinical Trials Information System (CTIS)	2005-003557-27
Protocol serial number	SA-388-4-1
Sponsor	Individual sponsor (Germany)
Funder	Deutsche Forschungsgemeinschaft (ref: DFG-AZ 60665-02-2/401/04)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Tilman Sauerbruch
Scientific

Sigmund-Freud-Str. 25
Bonn
53105
Germany

Phone	+49 (0)228 287 5216
Email	sauerbruch@uni-bonn.de

Primary study design	Interventional
Study design	Randomised controlled open multicentre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Covered transjugular intrahepatic portosystemic stent shunt versus optimised medical treatment for the secondary prevention of variceal bleeding in cirrhosis
Study objectives	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(s)	Ethics Committee of the University of Bonn, 23/01/2006, ref: 110/05
Health condition(s) or problem(s) studied	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 Applicable
Drug / device / biological / vaccine name(s)	Propanolol, isosorbide-5-mononitrate
Primary outcome measure(s)	Re-bleeding incidence
Key secondary outcome measure(s)	1. Overall survival 2. Safety 3. Quality of life 4. Direct and indirect costs
Completion date	01/09/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	186
Key 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 7. Written informed consent signed and dated by patient and investigator
Key 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
Date of first enrolment	01/03/2006
Date of final enrolment	01/09/2010

Sigmund-Freud-Str. 25

Bonn
53105
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

15/06/2017: Publication reference added.