Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222014
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2005-09-13
Brief Title:
TIPS With Coated Stents for Refractory Ascites in Patients With Cirrhosis
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
1 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
2 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
1 In all patients
Low salt diet 2 - 4 gj 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
1 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
2 Quality of Life
SF-36 Short Form 36 SF-36 Health Survey Questionnaire at inclusion and then every three months 18 19
2 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
3 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
I Treatments
1 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
2 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
1 In all patients
Low salt diet 2 - 4 gj 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
1 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
2 Quality of Life
SF-36 Short Form 36 SF-36 Health Survey Questionnaire at inclusion and then every three months 18 19
2 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
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC | None | None | None |