Trial Outcomes & Findings for Regeneration of Liver: Portal Vein Embolization Versus Radiofrequency Assisted Ligation for Liver Hypertrophy (REBIRTH) (NCT NCT02216773)
NCT ID: NCT02216773
Last Updated: 2019-11-07
Results Overview
Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)
Results posted on
2019-11-07
Participant Flow
Participant milestones
| Measure |
Portal Vein Embolization (PVE)
Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.
Portal vein embolization (PVE)
|
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
Underwent Procedure (PVE/RALPPS)
|
24
|
26
|
|
Overall Study
COMPLETED
|
16
|
24
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
| Measure |
Portal Vein Embolization (PVE)
Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.
Portal vein embolization (PVE)
|
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)
|
|---|---|---|
|
Overall Study
Disease progression
|
4
|
2
|
|
Overall Study
Insufficient FLRV
|
4
|
0
|
|
Overall Study
Abandoned
|
4
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Portal Vein Embolization (PVE)
n=24 Participants
Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.
Portal vein embolization (PVE)
|
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
n=26 Participants
Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 8.9 • n=24 Participants
|
62.4 years
STANDARD_DEVIATION 10.2 • n=26 Participants
|
63.3 years
STANDARD_DEVIATION 9.5 • n=50 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=24 Participants
|
11 Participants
n=26 Participants
|
23 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=24 Participants
|
15 Participants
n=26 Participants
|
27 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.
Outcome measures
| Measure |
Portal Vein Embolization (PVE)
n=24 Participants
Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.
Portal vein embolization (PVE)
|
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
n=26 Participants
Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)
|
|---|---|---|
|
Changes in Liver Remnant Volume
|
18.4 percentage change
Standard Deviation 9.8
|
80.7 percentage change
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization)Population: Data not collected
Blood tests
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to hospital discharge (estimated to be between 2 and 10 days)As defined by Dindo Clavien classification of surgical complications (≥grade 3b).
Outcome measures
| Measure |
Portal Vein Embolization (PVE)
n=24 Participants
Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.
Portal vein embolization (PVE)
|
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
n=26 Participants
Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)
|
|---|---|---|
|
Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)
|
1 Participants
|
4 Participants
|
Adverse Events
Portal Vein Embolization (PVE)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
Serious events: 4 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Portal Vein Embolization (PVE)
n=24 participants at risk
Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.
Portal vein embolization (PVE)
|
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
n=26 participants at risk
Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)
|
|---|---|---|
|
Surgical and medical procedures
Postoperative complication (Dindo Clavien ≥grade 3b)
|
4.2%
1/24 • Number of events 1 • 90 days
|
15.4%
4/26 • Number of events 4 • 90 days
|
Other adverse events
| Measure |
Portal Vein Embolization (PVE)
n=24 participants at risk
Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.
Portal vein embolization (PVE)
|
Radiofrequency Assisted Liver Partition and Ligation (RALPPS)
n=26 participants at risk
Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)
|
|---|---|---|
|
Surgical and medical procedures
Postoperative complication (Dindo Clavien <grade 3b)
|
54.2%
13/24 • Number of events 13 • 90 days
|
38.5%
10/26 • Number of events 10 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place