An interventional study of TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis and LVP in Liver Cirrhosis, Portal Hypertension and Ascites, sponsored by W.L.Gore & Associates. Terminated at 2 sites in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2014-06-03.
Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Treatment
The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 26 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →W.L.Gore & Associates is the lead sponsor of 95 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
> Patient has cirrhosis of the liver with portal hypertension
> Patient has difficult to treat ascites
> Patient is 18 years or older and \<70 years old at randomization
> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.
Exclusion Criteria:
> Patient has more than 6 large volume paracenteses within 90 days prior to randomization
> Patient is contraindicated for TIPS placement
> Patient has had previous TIPS placement
TIPS with GORE® VIATORR® TIPS Endoprosthesis
Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
Large Volume Paracentesis \*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure).
Procedure: LVP · Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
Large Volume Paracentesis
Transplant-free Survival
Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up. * Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination.
Time frame: Through 24 months
Overall Survival
Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. \> \*Note: Outcome measure entered below is number of subjects alive at time of study termination.
Time frame: Through 24 months
Time to Transplant
Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant. \*Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination.
Time frame: Through 24 months
Frequency of Paracentesis
Number of paracentesis post randomization
Time frame: Through 24 months
Frequency of Hepatic Encephalopathy
Number of episodes of West Haven grade 2 or greater
Time frame: Through 24 months
Procedural Success
Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein \*Note: Control (LVP) arm includes only subjects who crossed over to TIPS
Time frame: Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)
Liver Disease Complications (Adverse Events)
Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (\<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding.
Time frame: Through 24 months
| Milestone | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Started | 13 | 13 |
| Lvp crossover to tips | 0 | 4 |
| Completed | 2 | 0 |
| Not completed | 11 | 13 |
| Withdrew: Termination of study by sponsor | 11 | 13 |
Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up. * Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination.
| participants | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Transplant-free Survival | 11 | 13 |
Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. \> \*Note: Outcome measure entered below is number of subjects alive at time of study termination.
| participants | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Overall Survival | 11 | 13 |
Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant. \*Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination.
| participants | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Time to Transplant | 1 | 1 |
Number of paracentesis post randomization
| Number of episodes | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Frequency of Paracentesis | 25 | 93 |
Number of episodes of West Haven grade 2 or greater
| Number of episodes | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Frequency of Hepatic Encephalopathy | 4 | 2 |
Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein \*Note: Control (LVP) arm includes only subjects who crossed over to TIPS
| participants | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Procedural Success | 12 | 4 |
Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (\<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding.
| participants | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Total Subjects with Liver Disease Complication | 5 | 4 |
| Subjects with Variceal Bleeding | 0 | 0 |
| Subjects with Hepatic Hydrothorax | 2 | 1 |
| Subjects with Hepatoma | 0 | 1 |
| Subjects with Hepatorenal Syndrome Type 1 | 0 | 0 |
| Subjects with Hepatorenal Syndrome Type II | 0 | 1 |
| Subjects with Hyponatremia | 1 | 1 |
| Subjects with Spontaneous Bacterial Peritonitis | 0 | 0 |
| Subjects with Hepatic Encephalopathy | 3 | 1 |
Non-serious events are listed at a 5.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TIPS | — | 6/13 (46.2%) | 3/13 (23.1%) |
| LVP (Large Volume Paracentesis) | — | 2/13 (15.4%) | 3/13 (23.1%) |
| Event | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Hepatic encephalopathyNervous system disorders | 3/13 | 1/13 |
| Transient ischaemic attackNervous system disorders | 2/13 | 0/13 |
| Erosive esophagitisGastrointestinal disorders | 1/13 | 0/13 |
| Incarcerated umbilical herniaGastrointestinal disorders | 1/13 | 0/13 |
| Liver failureHepatobiliary disorders | 1/13 | 0/13 |
| Fungal sepsisInfections and infestations | 1/13 | 0/13 |
| Hyperglycemic hyperosmolar nonketotic syndromeMetabolism and nutrition disorders | 1/13 | 0/13 |
| HepatomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/13 | 1/13 |
| HematuriaRenal and urinary disorders | 1/13 | 0/13 |
| Umbilical hernia repairSurgical and medical procedures | 1/13 | 1/13 |
| Event | TIPS | LVP (Large Volume Paracentesis) |
|---|---|---|
| Hepatic hydrothoraxRespiratory, thoracic and mediastinal disorders | 2/13 | 1/13 |
| Hepatorenal syndromeHepatobiliary disorders | 0/13 | 1/13 |
| HyponatremiaMetabolism and nutrition disorders | 1/13 | 1/13 |
| Hepatic encephalopathyNervous system disorders | 1/13 | 0/13 |
Patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites
| Age, Continuous(years) | TIPS | LVP (Large Volume Paracentesis) | Total |
|---|---|---|---|
| Mean | 58.4 ± 6.6 | 57.5 ± 8.0 | 58.0 ± 7.2 |
| Sex: Female, Male(Participants) | TIPS | LVP (Large Volume Paracentesis) | Total |
|---|---|---|---|
| Female | 6 | 2 | 8 |
| Male | 7 | 11 | 18 |
| Region of Enrollment(participants) | TIPS | LVP (Large Volume Paracentesis) | Total |
|---|---|---|---|
| United States | 11 | 9 | 20 |
| Canada | 2 | 4 | 6 |
This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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W.L.Gore & Associates