Trial Outcomes & Findings for Early TIPS for Ascites Study (NCT NCT01236339)
NCT ID: NCT01236339
Last Updated: 2014-06-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Through 24 months
Results posted on
2014-06-03
Participant Flow
Participant milestones
| Measure |
TIPS
TIPS with GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
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)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
LVP Crossover to TIPS
|
0
|
4
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
TIPS
TIPS with GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
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)
|
|---|---|---|
|
Overall Study
Termination of study by sponsor
|
11
|
13
|
Baseline Characteristics
Early TIPS for Ascites Study
Baseline characteristics by cohort
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 Participants
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).
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 24 monthsTime 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.
Outcome measures
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 Participants
LVP: Large Volume Paracentesis
|
|---|---|---|
|
Transplant-free Survival
|
11 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Through 24 monthsTime 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.
Outcome measures
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 Participants
LVP: Large Volume Paracentesis
|
|---|---|---|
|
Overall Survival
|
11 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Through 24 monthsTime 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.
Outcome measures
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 Participants
LVP: Large Volume Paracentesis
|
|---|---|---|
|
Time to Transplant
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Through 24 monthsNumber of paracentesis post randomization
Outcome measures
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 Participants
LVP: Large Volume Paracentesis
|
|---|---|---|
|
Frequency of Paracentesis
|
25 Number of episodes
|
93 Number of episodes
|
SECONDARY outcome
Timeframe: Through 24 monthsNumber of episodes of West Haven grade 2 or greater
Outcome measures
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 Participants
LVP: Large Volume Paracentesis
|
|---|---|---|
|
Frequency of Hepatic Encephalopathy
|
4 Number of episodes
|
2 Number of episodes
|
SECONDARY outcome
Timeframe: Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)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
Outcome measures
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=4 Participants
LVP: Large Volume Paracentesis
|
|---|---|---|
|
Procedural Success
|
12 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Through 24 monthsOverall 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.
Outcome measures
| Measure |
TIPS
n=13 Participants
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 Participants
LVP: Large Volume Paracentesis
|
|---|---|---|
|
Liver Disease Complications (Adverse Events)
Total Subjects with Liver Disease Complication
|
5 participants
|
4 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Variceal Bleeding
|
0 participants
|
0 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Hepatic Hydrothorax
|
2 participants
|
1 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Hepatoma
|
0 participants
|
1 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Hepatorenal Syndrome Type 1
|
0 participants
|
0 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Hepatorenal Syndrome Type II
|
0 participants
|
1 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Hyponatremia
|
1 participants
|
1 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Spontaneous Bacterial Peritonitis
|
0 participants
|
0 participants
|
|
Liver Disease Complications (Adverse Events)
Subjects with Hepatic Encephalopathy
|
3 participants
|
1 participants
|
Adverse Events
TIPS
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
LVP (Large Volume Paracentesis)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TIPS
n=13 participants at risk
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Erosive esophagitis
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Hepatobiliary disorders
Liver failure
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Fungal sepsis
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hyperglycemic hyperosmolar nonketotic syndrome
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatoma
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
23.1%
3/13 • Number of events 3
|
7.7%
1/13 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
15.4%
2/13 • Number of events 2
|
0.00%
0/13
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Surgical and medical procedures
Umbilical hernia repair
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
TIPS
n=13 participants at risk
TIPS with GORE® VIATORR® TIPS Endoprosthesis \>
\> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
|
LVP (Large Volume Paracentesis)
n=13 participants at risk
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).
|
|---|---|---|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax
|
15.4%
2/13 • Number of events 2
|
7.7%
1/13 • Number of events 2
|
Additional Information
Arthur Scott / Clinical Study Manager
W.L. Gore and Associates, Inc.
Phone: 623.234.5263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER