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The aim of this study is to compare two different techniques (portal vein embolization and radiofrequency assisted liver partition with portal vein ligation) for increasing liver volume prior to major liver resection.
Liver resection remains the gold standard treatment for patients with liver tumours providing them the only chance for long-term survival. In up to 45% of cases that are amenable to surgical resection, an extended hepatectomy (removal of part of the liver) is usually necessary to achieve a clear resection margin. However, there must be enough liver left behind to meet the demands of the body. Indeed, liver failure due to insufficient remnant liver volume is still the principal cause of postoperative death following a major liver resection.
The liver receives its main blood supply from two vessels (the portal vein and the hepatic artery). In order to decrease the complications and improve the safety of extensive liver surgery in patients with insufficient future liver remnant volume (FLRV), pre-operative embolization (i.e. blockage) of part of the portal vein can be undertaken.
This has the effect of inducing growth of the liver on the unaffected side. Thus, when the resection is carried out, an increased FLRV (of around 12%) reduces post-operative liver failure. An alternative technique is to perform surgical ligation of the portal vein along with splitting of the liver.
The diseased portion of liver is left in the body for 7-10 days while the healthy side is induced to grow. During this time, the diseased portion continues to support the body's requirement for liver function and reduces the risk of liver failure. FLRV has been shown to increase by around 74% with this technique.
However, there are more postoperative complications with the alternative technique such as bile leaks. The aim of this study is to test a new way of splitting the liver so that the increased FLRV can be achieved without the increased complication rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portal vein embolization (PVE) | Active Comparator | Patients allocated to the PVE group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their portal vein embolized radiologically once their pre-intervention investigations have been completed and reviewed by the clinical team. Post-intervention investigations (blood tests and CT scan) will take place 4 weeks after the completion of the PVE. At this point, they will be listed to receive their definitive surgical hepatectomy. |
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| Radiofrequency assisted liver partition and ligation (RALPP) | Experimental | Patients allocated to the RALPP group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may additionally have a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPP procedure will occur once the patient's pre-intervention investigations have been completed and reviewed by the clinical team. Post-intervention investigations (blood tests and CT scan) will take place 2 weeks after the completion of the RALPP. At this point, they will be listed to receive their definitive surgical hepatectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency assisted liver partition with portal vein ligation (RALPP) | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Liver Remnant Volume | 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. | 2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Liver Function Tests | Blood tests | Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization) |
| Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Long R Jiao, MD, FRCS | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24670841 | Background | Gall TM, Sodergren MH, Frampton AE, Fan R, Spalding DR, Habib NA, Pai M, Jackson JE, Tait P, Jiao LR. Radio-frequency-assisted Liver Partition with Portal vein ligation (RALPP) for liver regeneration. Ann Surg. 2015 Feb;261(2):e45-6. doi: 10.1097/SLA.0000000000000607. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2014 |
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| Portal vein embolization (PVE) |
| Procedure |
|
As defined by Dindo Clavien classification of surgical complications (≥grade 3b).
| Up to hospital discharge (estimated to be between 2 and 10 days) |
| FG001 | 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) |
| Underwent Procedure (PVE/RALPPS) |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Liver Remnant Volume | 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. | Posted | Mean | Standard Deviation | percentage change | 2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE) |
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| Secondary | Postoperative Liver Function Tests | Blood tests | Data not collected | Posted | Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization) |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b) | As defined by Dindo Clavien classification of surgical complications (≥grade 3b). | Posted | Count of Participants | Participants | Up to hospital discharge (estimated to be between 2 and 10 days) |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 24 | 1 | 24 | 13 | 24 |
| EG001 | 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) | 1 | 26 | 4 | 26 | 10 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative complication (Dindo Clavien ≥grade 3b) | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative complication (Dindo Clavien <grade 3b) | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Long Jiao | Imperial College London | +44 2033133937 | l.jiao@imperial.ac.uk |
| Aug 15, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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