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Safety concerns.
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This randomized phase II trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would traditionally be considered inoperable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ALPPS) | Experimental | Patients undergo Associating Liver Partition with Portal Vein Ligation (ALPPS) step 1 surgery on day 0 and step 2 surgery 7-14 days later, based on patient's liver size. |
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| Arm II (PVO) | Active Comparator | Patients undergo portal vein occlusion (PVO) step 1 on day 0 and step 2 surgery 6-8 weeks later, based on patient's liver size. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALPPS surgery | Procedure |
| ||
| PVO surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Liver free of tumors | Assessed by two independent and blinded radiologists using dynamic MRI with liver specific contrast; proportion of patients in each treatment arm; incidence across two arms will be summarized using contingency tables and compared by 2-sample Chi-square test or Fisher's exact test. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Kaplan-Meier product limit estimator will be used to describe the distribution of overall survival (OS). The differences in OS between treatment arms will be compared using log-rank test. | Up to 3 years |
| Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion of Women and Minorities
-Both men and women and members of all races and ethnic groups are eligible for this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Strasberg, M.D. | Washington University School of Medicine | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Kaplan-Meier product limit estimator will be used to describe the distribution disease-free survival (DFS). The differences in DFS between treatment arms will be compared using log-rank test.
| Up to 3 years |
| Incidence of complications | Each patient will be categorized according to the most severe complication occurring during the two procedures of each arm; distributions across two arms will be compared by 2-sample Chi-square test or Fisher's exact test. | 3 months |
| Liver volumetric change after step 1 of ALPPS or PVO | Assessed at 1, 2, 4 and 8 weeks after step 1 using CT or MRI imaging; differences between two arms will be compared using 2-way ANOVA for repeated measurement data | 8 weeks |
| Liver synthetic and transport function | PT/INR, factor V and bilirumen are measured; differences between two treatment arms will be compared using t-test or Mann-Whitney rank-sum test as appropriate. | 3 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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