PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-hepatic Porto-systemic Sh… (NCT00593528) | Clinical Trial Compass
CompletedNot Applicable
PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)
France138 participantsStarted 2008-02-18
Plain-language summary
Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis.
The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus owing the pseudointimal hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt and thus its efficacy. Since the beginning of the 2000s, appeared stents known as "covered" by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive than the non covered stents and the cost-effectiveness ratio of the TIPS according to the type of stents used has not been assessed.
The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE but requiring regular gestures of redilatation.
Population concerned: Patients with a cirrhotic portal hypertension responsible for:
* recurrent variceal bleeding
* refractory ascite (or hydrothorax)
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of a cirrhosis as documented by previous liverbiopsy or typical clinical signs
* Indication validated of the TIPS (Bavéno IV), except not-controlled acute hemorrhagic :
* Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods
* Refractory or recurrent ascites or difficult to treat
* Refractory Hydrothorax
Exclusion Criteria:
* Non cirrhotic HTP
* CHILD C ≥12
* Complete portal vein thrombosis
* Usual contra-indication for TIPS :
* Known or suspected Hepatocarcinoma by increase of the alpha-foetoprotein \>100 UI/mL associated with the presence of at least one hepatic nodule
* Cardiac insufficiency defined by a ventricular fraction of ejection \< 40% with the echocardiography preliminary to the procedure
* Pulmonary arterial hypertension (PAP \> 40 mmHg)
* Hepatic polycystosis
* Intra-hepatic bile ducts dilatation,
* Spontaneous clinical recurrent hepatic encephalopathy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TIPS permeability rate
Timeframe: one year
2
Cost of the TIPS and patient care according to the type of stent used brought back to an indicator of effectiveness