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Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with biliary cancer should not be treated by ALPPS. Short-term results of ALPPS variants with reduced surgical trauma on the first stage in patients with cholangiocarcinoma were not yet estimated. The objective of the study was estimation of the short-term results of split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage (RALPPS) in patients with hilar (h-CCA) and intrahepatic (i-CCA) cholangiocarcinoma compared with portal vein embolization (PVE).
ALPPS has been recently proposed as the most effective method to induce marked and rapid hypertrophy of FLR with 95-100% completion rate of the second stage. The most common indication for ALPPS is locally advanced multiple colorectal liver metastases. Unsatisfactory immediate outcomes of ALPPS in surgery of cholangiocarcinoma (CCA) including high mortality reached 48% in patients with h-CCA suggested that patients with biliary cancer should not be treated by ALPPS.
Recently reported modifications of in situ splitting (partial ALPPS, RALPPS (radio-frequency-assisted liver partition with portal vein ligation for staged hepatectomy) and ALTPS (associating liver tourniquet and right portal vein ligation for staged hepatectomy) etc) have been aimed to minimize the operating injury on the first stage, hereby reducing postoperative morbidity.
The other important idea was to preserve all initial benefits of ALPPS in terms of liver hypertrophy and completeness of the second stage. To date, there is no evidence of the benefits of any new ALPPS modification over others in reducing the morbidity of procedure, particularly in patients with CCA..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RALPPS | Patients with initial volume of FLR < 40% which underwent RALPPS and major liver resection (as the second stage of RALPPS) for hilar and intrahepatic cholangiocarcinoma |
| |
| Portal vein embolization (PVE) | Patients with initial volume of FLR < 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RALPPS | Procedure | RALPPS: split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage and major liver resection on the second stage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Future Liver Remnant (FLR) Hypertrophy | Degree of FLR enlargement (%) with respect to initial volume of FLR [(Post-PVE FLR - Pre-PVE FLR) / (Pre-PVE FLR)] x 100 | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major morbidity after the first stage | Grade > II according to Clavien-Dindo classification | 10 days |
| Blood loss | Blood loss during second stage (major liver resection) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients refered to the Center from other hospitals and primary care clinics
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Efanov | Moscow Clinical Scientific Center | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2017 | Oct 24, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2017 | Oct 24, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| portal vein embolization + major liver resection | Procedure | PVE on the first stage and major liver resection on the second stage |
|
| intraoperative parameter |
| Major morbidity after the second stage | Grade > II according to Clavien-Dindo classification | 90 days |
| Liver failure | Liver failure after the second stage according to criteria of International Study Group of Liver Surgery | 10 days |
| D009369 | Neoplasms |