Trial Outcomes & Findings for Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE (NCT NCT03170869)
NCT ID: NCT03170869
Last Updated: 2022-01-12
Results Overview
For the outcome of local recurrence rate (LRR) we will test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type using a Fisher's exact test.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
6 months
Results posted on
2022-01-12
Participant Flow
Participant milestones
| Measure |
DEB-TACE Procedure With Surefire Precision Infusion System
The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.
The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.
The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.
The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
DEB-TACE Procedure With Surefire Precision Infusion System
The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.
The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.
The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.
The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.
|
|---|---|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Early study termination
|
3
|
Baseline Characteristics
Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE
Baseline characteristics by cohort
| Measure |
DEB-TACE Procedure With Surefire Precision Infusion System
n=11 Participants
The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.
The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.
The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.
The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60.27 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Zero participants analyzed as the study was terminated prior to data for outcome measures to be assessed. No data was collected or analyzed for this outcome measure.
For the outcome of local recurrence rate (LRR) we will test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type using a Fisher's exact test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Zero participants analyzed as the study was terminated prior to data for outcome measures to be assessed. No data was collected or analyzed for this outcome measure.
For the outcome of tumor response measured as the change in enhancing tumor size (pretreatment - post treatment) we will evaluate changes at 1 month and 6 month separately.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 months through 24 monthsPopulation: Zero participants analyzed as the study was terminated. No data was collected or analyzed for this outcome measure.
For the outcome of time to progression, we will quantify the number of weeks from treatment until tumor progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 months through 24 monthsPopulation: Zero participants analyzed as the study was terminated prior to data for outcome measures to be assessed. No data was collected or analyzed for this outcome measure.
For the outcome of survival time, we will quantify the number of weeks from treatment until death.
Outcome measures
Outcome data not reported
Adverse Events
DEB-TACE Procedure With Surefire Precision Infusion System
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DEB-TACE Procedure With Surefire Precision Infusion System
n=11 participants at risk
The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.
The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.
The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.
The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.
|
|---|---|
|
Hepatobiliary disorders
Abdominal pain
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Infection
|
9.1%
1/11 • Number of events 2 • 6 months from the baseline procedure with the Surefire device
|
Other adverse events
| Measure |
DEB-TACE Procedure With Surefire Precision Infusion System
n=11 participants at risk
The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.
The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.
The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.
The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.
|
|---|---|
|
Hepatobiliary disorders
Flow limiting dissection of the anterior right hepatic artery
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Abdominal pain
|
54.5%
6/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Nausea
|
45.5%
5/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Fatigue
|
45.5%
5/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Chest pain during sleep
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Elevated AFP levels
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Occasional hot flashes
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Mild groin paint post re-treatment
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Elevated Hep C Quantitative PCR
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Muscle wasting
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Abdominal distention
|
27.3%
3/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Edema
|
27.3%
3/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Admission for infection
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Increased AFib
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Blood bilirubin increased
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Hypoalbuminemia
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Elevated INR levels
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Headaches
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Fever and chills
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Post embolization sydrome
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Difficulty with pain control
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Elevated lactate whole blood venous levels
|
27.3%
3/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Cough and chest tightness
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Platelet count decreased
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Encephalopathy
|
18.2%
2/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Elevated ammonia levels
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Dizziness
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Acute kidney injury
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Hyperkalemia
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Constipation
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Depression
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
|
General disorders
Ascites
|
9.1%
1/11 • 6 months from the baseline procedure with the Surefire device
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place