Early TIPS for Ascites Study

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01236339
• Collaborator: (none)
• Enrollment: 26
• Locations: 2
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 13
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; Portal Hypertension; Ascites	Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis; Procedure: LVP; Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TIPS TIPS with GORE® VIATORR® TIPS Endoprosthesis	Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis; TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
Active Comparator: LVP 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; Large Volume Paracentesis; Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol

Outcome Measures

Primary Outcome Measures

1. Transplant-free Survival [Through 24 months]

   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.

Secondary Outcome Measures

1. Overall Survival [Through 24 months]

   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.

2. Time to Transplant [Through 24 months]

   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.

3. Frequency of Paracentesis [Through 24 months]

   Number of paracentesis post randomization

4. Frequency of Hepatic Encephalopathy [Through 24 months]

   Number of episodes of West Haven grade 2 or greater

5. Procedural Success [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

6. Liver Disease Complications (Adverse Events) [Through 24 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States
2	University of Maryland-Baltimore	Baltimore	Maryland	United States

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: Thomas Boyer, MD, University of Arizona College of Medicine
• Principal Investigator: Ziv Haskal, MD, University of Maryland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT01236339
• Other Study ID Numbers: VTR 10-03
• First Posted: Nov 8, 2010
• Last Update Posted: Jun 3, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Ascites

Study Results

Participant Flow

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	TIPS with 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)
Period Title: Overall Study
STARTED	13	13
LVP Crossover to TIPS	0	4
COMPLETED	2	0
NOT COMPLETED	11	13

Baseline Characteristics

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)	Total
Arm/Group Description	TIPS with GORE® VIATORR® TIPS Endoprosthesis > > TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: 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).	Total of all reporting groups
Overall Participants	13	13	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.4 (6.6)	57.5 (8.0)	58.0 (7.2)
Sex: Female, Male (Count of Participants)
Female	6 46.2%	2 15.4%	8 30.8%
Male	7 53.8%	11 84.6%	18 69.2%
Region of Enrollment (participants) [Number]
United States	11 84.6%	9 69.2%	20 76.9%
Canada	2 15.4%	4 30.8%	6 23.1%

Outcome Measures

1. Primary Outcome

Title	Transplant-free Survival
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	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
Measure Participants	13	13
Number [participants]	11 84.6%	13 100%

2. Secondary Outcome

Title	Overall Survival
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	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
Measure Participants	13	13
Number [participants]	11 84.6%	13 100%

3. Secondary Outcome

Title	Time to Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	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
Measure Participants	13	13
Number [participants]	1 7.7%	1 7.7%

4. Secondary Outcome

Title	Frequency of Paracentesis
Description	Number of paracentesis post randomization
Time Frame	Through 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	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
Measure Participants	13	13
Number [Number of episodes]	25	93

5. Secondary Outcome

Title	Frequency of Hepatic Encephalopathy
Description	Number of episodes of West Haven grade 2 or greater
Time Frame	Through 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	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
Measure Participants	13	13
Number [Number of episodes]	4	2

6. Secondary Outcome

Title	Procedural Success
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	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
Measure Participants	13	4
Number [participants]	12 92.3%	4 30.8%

7. Secondary Outcome

Title	Liver Disease Complications (Adverse Events)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TIPS	LVP (Large Volume Paracentesis)
Arm/Group Description	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
Measure Participants	13	13
Total Subjects with Liver Disease Complication	5 38.5%	4 30.8%
Subjects with Variceal Bleeding	0 0%	0 0%
Subjects with Hepatic Hydrothorax	2 15.4%	1 7.7%
Subjects with Hepatoma	0 0%	1 7.7%
Subjects with Hepatorenal Syndrome Type 1	0 0%	0 0%
Subjects with Hepatorenal Syndrome Type II	0 0%	1 7.7%
Subjects with Hyponatremia	1 7.7%	1 7.7%
Subjects with Spontaneous Bacterial Peritonitis	0 0%	0 0%
Subjects with Hepatic Encephalopathy	3 23.1%	1 7.7%

Adverse Events

Arm/Group Title	TIPS		LVP (Large Volume Paracentesis)
Arm/Group Description	TIPS with GORE® VIATORR® TIPS Endoprosthesis > > TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: 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).
All Cause Mortality
	TIPS		LVP (Large Volume Paracentesis)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TIPS		LVP (Large Volume Paracentesis)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/13 (46.2%)		2/13 (15.4%)
Gastrointestinal disorders
Erosive esophagitis	1/13 (7.7%)	1	0/13 (0%)	0
Incarcerated umbilical hernia	1/13 (7.7%)	1	0/13 (0%)	0
Hepatobiliary disorders
Liver failure	1/13 (7.7%)	1	0/13 (0%)	0
Infections and infestations
Fungal sepsis	1/13 (7.7%)	1	0/13 (0%)	0
Metabolism and nutrition disorders
Hyperglycemic hyperosmolar nonketotic syndrome	1/13 (7.7%)	1	0/13 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatoma	0/13 (0%)	0	1/13 (7.7%)	1
Nervous system disorders
Hepatic encephalopathy	3/13 (23.1%)	3	1/13 (7.7%)	2
Transient ischaemic attack	2/13 (15.4%)	2	0/13 (0%)	0
Renal and urinary disorders
Hematuria	1/13 (7.7%)	1	0/13 (0%)	0
Surgical and medical procedures
Umbilical hernia repair	1/13 (7.7%)	1	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	TIPS		LVP (Large Volume Paracentesis)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/13 (23.1%)		3/13 (23.1%)
Hepatobiliary disorders
Hepatorenal syndrome	0/13 (0%)	0	1/13 (7.7%)	1
Metabolism and nutrition disorders
Hyponatremia	1/13 (7.7%)	1	1/13 (7.7%)	1
Nervous system disorders
Hepatic encephalopathy	1/13 (7.7%)	1	0/13 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax	2/13 (15.4%)	2	1/13 (7.7%)	2

Limitations/Caveats

Early termination due to very low enrollment.No subjects completed 24 month follow-up,sample size too small for adequate statistical analysis.Collected Adverse Events limited to hospitalizations and Liver Disease Complications as defined in protocol.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.