CirrhosisNCT00222014
TIPS With Coated Stents for Refractory Ascites in Patients With Cirrhosis
A study testing TIPS and Paracenthese in people with Cirrhosis, run by University Hospital, Toulouse at 4 sites in France.
Trial summary
The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- TIPS and Paracenthese
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 4 sitesFrance
- Study dates
- May 2005to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of both sexes, with cirrhosis, as documented by previous liver-biopsy or usual clinical and biochemical stigmata
- with refractory or recurrent ascites as defined in chapter IV
- who signed the informed consent form
Who cannot join
- patients not fulfilling inclusion criteria
- patients having needed more than 6 paracenteses within the last 3 months
- patients expected to be transplanted within the next 6 months
- usual contra-indication for TIPS : congestive heart failure NYHA>III or medical history of pulmonary hypertension, portal vein thrombosis, hepatic polycystosis, intra-hepatic bile ducts dilatation, spontaneous clinical recurrent hepatic encephalopathy
- hepatocarcinoma on the expected tract of the shunt
- severe liver failure as defined by : Prothrombin index < 35 % or total bilirubin > 100 micromol/l or Child Pugh Score >12
Show all 11Show fewer
- serum creatinine > 250 micromol/l
- uncontrolled sepsis
- known allergy to albumin
- pregnant or breast feeding women
- refusal to participate or patient unable to receive informations or to sign written informed consent
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital
Angers, 49000
University Hospital
Lille, 59000
Hôpital de la Pitié-Salpétrière
Paris, 75000
Service d'Hépato-Gastro-Entérologie, Hôpital Purpan
Toulouse, 31059
About this study
Official title: TIPS (With Coated Stents) OR PARACENTESIS + ALBUMIN ADMINISTRATION FOR THE TREATMENT OF REFRACTORY ASCITES IN PATIENTS WITH CIRRHOSIS : A RANDOMIZED TRIAL COMPARING SURVIVAL, QUALITY OF LIFE AND NUTRITIONAL STATUS
The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion.
Read the detailed description
Diagnostic evaluation before randomisation includes assessment of clinical hepatic encephalopathy, usual blood tests, and Doppler-ultrasonography of the abdomen. Inclusion and exclusion criteria will be checked during the inclusion visit. Informations concerning the trial will also be given. After the investigator receives written informed consent, randomisation will be performed online. Randomisation will be centralized, equilibrated for each center, stratified according to whether cirrhosis is alcoholic or not and adjusted every ten patients.
I Treatments
- TIPS : TIPS will be performed under sedation or general anesthesia with tracheal intubation according to the usual policy of participating centers. Pre-tips portosystemic pressure gradient and diameter of the shunt must be notified. However, for homogeneity reasons the following will be adhered: A 10 mm Viator stent will be used, that will be dilated to 8 or 10 mm according to the hemodynamic response. The aim will be to reduce portal pressure gradient (PPG) below 12 mmHg. Ideal PPG should be 7-8 mmHg.
- Paracentesis + albumin infusion :
After a paracentesis > 3 liters, 8 g of Albumin per liter of extracted ascites must be infused.
If possible, analysis of ascitic fluid will be performed after each paracentesis for biochemical, cytological and bacterial analyses.
II Follow up
- In all patients: Low salt diet (2 - 4 g/j). Follow up of the patient is as usual. Patients will have a clinical examination at 1 month and then every 3 months up to 1 year. At each visit, clinical and biochemical variables needed to calculate Child-Pugh score will be recorded. Doppler ultrasonography will be performed at the beginning, 6 and 12 months. Patients will be followed 1 year or until liver transplantation or death.
- Nutritional status evaluation:
- Weight: M0, M3, M6, M9, M12
- Anthropometrics measurements: M0, M3, M6, M12: they will include : triceps skinfold thickness, biceps skinfold thickness, brachial circumference.
- Biochemical parameters: M0, M3, M6, M12: they will include : albumin, pre-albumin, orosomucoïde, C-reactive protein, haptoglobin, natriuresis, 24 hour urinary excretion of creatinine. Four blood samples will be collected and conserved for a posteriori analysis if required (transferrin, retinol binding protein, leptin, hormonal dosages). These analyses will be centralized in Toulouse (Toulouse center will be charged for the shipment of those blood samples).
- Physical parameters: dual energy x-ray absorptiometry M0, M12
- Grip test M0, M6, M12 [16, 17].
- Quality of Life : SF-36 (Short Form 36 (SF-36) Health Survey Questionnaire) at inclusion and then every three months [18, 19].
- Paracentesis + albumin infusion group: Patients included in this group will be treated by paracentesis whenever required. Eight grams of albumin per liter of ascites extracted will be infused when more than 3 liters of ascitic fluid will be removed.
- TIPS group :
When shunt dysfunction will be suspected because of relapse of ascites or incomplete response 2 months after the procedure, an angiography and PPG measurement will be performed. If shunt dysfunction is confirmed, angioplasty or PTFE re-stenting will aim at reducing PPG below 12 mmHg.
III Definition of treatment failure:
After TIPS: relapse of ascites requiring at least 2 paracenteses or persistence after 2 months will be considered as treatment failure. A hemodynamic and angiographic control will be performed. Patients will be treated by refection of the shunt. If severe encephalopathy occurs and persists despite treatment, the diameter of the shunt should be decreased or the TIPS occluded. Total occlusion of the shunt or relapse of ascites after the reduction of its diameter will be also considered treatment failures.
In the group treated by paracentesis + albumin infusion, patients having more than 6 paracenteses within 3 months will be considered for alternative treatment (TIPS, transplantation). Technical impossibility or refusal of the patient to proceed with paracenteses will be also considered treatment failure. In these cases, a TIPS could also be proposed.
All these patients with treatment failure must be followed up to one year after inclusion
- Conditions
- Cirrhosis
- Being tested
- TIPS, Paracenthese
- Keywords
- Refractory ascites, Cirrhosis, Paracentesesis
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPSProcedure or surgery
Transjugular intrahepatic portosystemic shunt with covered PTFE
ParacentheseProcedure or surgery
Paracenthese
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TIPS réalisé avec prothèse couverte de PTFE Receives: Procedure: TIPS |
| 2 | Active comparator | Paracenthese and albumine perfusion Receives: Procedure: Paracenthese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at one year
Measured: one year
Secondary outcomes (1)
Quality of life, nutritional status, occurrence of complications (other than ascites) secondary to portal hypertension.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, GORE Laboratory
- Responsible party
- Sponsor
- Investigators
- BUREAU Christophe, MD, Principal investigator, University Hospital, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222014
- Sponsor's protocol ID
- 0402308
- Other IDs
- PHRC
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2005
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Peron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75. doi: 10.1053/j.gastro.2003.11.016.
PubMed 14762784Gonzalez-Garay AG, Serralde-Zuniga AE, Velasco Hidalgo L, Flores Garcia NC, Aguirre-Salgado MI. Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome. Cochrane Database Syst Rev. 2024 Jan 18;1(1):CD011039. doi: 10.1002/14651858.CD011039.pub2.
PubMed 38235907Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Peron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20.
PubMed 27663604
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIPS (With Coated Stents) OR PARACENTESIS + ALBUMIN ADMINISTRATION FOR THE TREATMENT OF REFRACTORY ASCITES IN PATIENTS WITH CIRRHOSIS : A RANDOMIZED TRIAL COMPARING SURVIVAL, QUALITY OF LIFE AND NUTRITIONAL STATUS
- ClinicalTrials.gov ID
- NCT00222014
- Acronym / sponsor ID
- 0402308
- Conditions
- Cirrhosis
- Keywords
- Refractory ascites, Cirrhosis, Paracentesesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Ministry of Health, France, GORE Laboratory
- Study start
- May 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion.
Detailed description
Diagnostic evaluation before randomisation includes assessment of clinical hepatic encephalopathy, usual blood tests, and Doppler-ultrasonography of the abdomen. Inclusion and exclusion criteria will be checked during the inclusion visit. Informations concerning the trial will also be given. After the investigator receives written informed consent, randomisation will be performed online. Randomisation will be centralized, equilibrated for each center, stratified according to whether cirrhosis is alcoholic or not and adjusted every ten patients.
I Treatments
- TIPS : TIPS will be performed under sedation or general anesthesia with tracheal intubation according to the usual policy of participating centers. Pre-tips portosystemic pressure gradient and diameter of the shunt must be notified. However, for homogeneity reasons the following will be adhered: A 10 mm Viator stent will be used, that will be dilated to 8 or 10 mm according to the hemodynamic response. The aim will be to reduce portal pressure gradient (PPG) below 12 mmHg. Ideal PPG should be 7-8 mmHg.
- Paracentesis + albumin infusion :
After a paracentesis > 3 liters, 8 g of Albumin per liter of extracted ascites must be infused.
If possible, analysis of ascitic fluid will be performed after each paracentesis for biochemical, cytological and bacterial analyses.
II Follow up
- In all patients: Low salt diet (2 - 4 g/j). Follow up of the patient is as usual. Patients will have a clinical examination at 1 month and then every 3 months up to 1 year. At each visit, clinical and biochemical variables needed to calculate Child-Pugh score will be recorded. Doppler ultrasonography will be performed at the beginning, 6 and 12 months. Patients will be followed 1 year or until liver transplantation or death.
- Nutritional status evaluation:
- Weight: M0, M3, M6, M9, M12
- Anthropometrics measurements: M0, M3, M6, M12: they will include : triceps skinfold thickness, biceps skinfold thickness, brachial circumference.
- Biochemical parameters: M0, M3, M6, M12: they will include : albumin, pre-albumin, orosomucoïde, C-reactive protein, haptoglobin, natriuresis, 24 hour urinary excretion of creatinine. Four blood samples will be collected and conserved for a posteriori analysis if required (transferrin, retinol binding protein, leptin, hormonal dosages). These analyses will be centralized in Toulouse (Toulouse center will be charged for the shipment of those blood samples).
- Physical parameters: dual energy x-ray absorptiometry M0, M12
- Grip test M0, M6, M12 [16, 17].
- Quality of Life : SF-36 (Short Form 36 (SF-36) Health Survey Questionnaire) at inclusion and then every three months [18, 19].
- Paracentesis + albumin infusion group: Patients included in this group will be treated by paracentesis whenever required. Eight grams of albumin per liter of ascites extracted will be infused when more than 3 liters of ascitic fluid will be removed.
- TIPS group :
When shunt dysfunction will be suspected because of relapse of ascites or incomplete response 2 months after the procedure, an angiography and PPG measurement will be performed. If shunt dysfunction is confirmed, angioplasty or PTFE re-stenting will aim at reducing PPG below 12 mmHg.
III Definition of treatment failure:
After TIPS: relapse of ascites requiring at least 2 paracenteses or persistence after 2 months will be considered as treatment failure. A hemodynamic and angiographic control will be performed. Patients will be treated by refection of the shunt. If severe encephalopathy occurs and persists despite treatment, the diameter of the shunt should be decreased or the TIPS occluded. Total occlusion of the shunt or relapse of ascites after the reduction of its diameter will be also considered treatment failures.
In the group treated by paracentesis + albumin infusion, patients having more than 6 paracenteses within 3 months will be considered for alternative treatment (TIPS, transplantation). Technical impossibility or refusal of the patient to proceed with paracenteses will be also considered treatment failure. In these cases, a TIPS could also be proposed.
All these patients with treatment failure must be followed up to one year after inclusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: TIPSTIPS réalisé avec prothèse couverte de PTFE |
| 2 | Active comparator | Procedure: ParacentheseParacenthese and albumine perfusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients of both sexes, with cirrhosis, as documented by previous liver-biopsy or usual clinical and biochemical stigmata
- with refractory or recurrent ascites as defined in chapter IV
- who signed the informed consent form
Key exclusion criteria (11 listed)
- patients not fulfilling inclusion criteria
- patients having needed more than 6 paracenteses within the last 3 months
- patients expected to be transplanted within the next 6 months
- usual contra-indication for TIPS : congestive heart failure NYHA>III or medical history of pulmonary hypertension, portal vein thrombosis, hepatic polycystosis, intra-hepatic bile ducts dilatation, spontaneous clinical recurrent hepatic encephalopathy
- hepatocarcinoma on the expected tract of the shunt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIPSTransjugular intrahepatic portosystemic shunt with covered PTFE | Procedure or surgery | 1 |
| ParacentheseParacenthese | Procedure or surgery | 2 |
Primary outcome
Survival at one year
Time frame: one year
1 secondary outcome
Quality of life, nutritional status, occurrence of complications (other than ascites) secondary to portal hypertension.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Background: PubMed 14762784Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Peron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75. doi: 10.1053/j.gastro.2003.11.016.
- Derived from this study: PubMed 38235907Gonzalez-Garay AG, Serralde-Zuniga AE, Velasco Hidalgo L, Flores Garcia NC, Aguirre-Salgado MI. Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome. Cochrane Database Syst Rev. 2024 Jan 18;1(1):CD011039. doi: 10.1002/14651858.CD011039.pub2.
- Derived from this study: PubMed 27663604Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Peron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BUREAU Christophe, MD principal investigator
University Hospital, Toulouse, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS and Paracenthese in people with Cirrhosis, run by University Hospital, Toulouse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at one year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222014, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.