RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

Study Overview
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Brief Summary
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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).

Detailed Description
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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..

Official Title
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Split-in-situ Resection With Radio-frequency Ablation Instead of Liver Partition on the First Stage (RALPPS) in Patients With Hilar and Intrahepatic Cholangiocarcinoma

Conditions
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Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Procedure: RALPPS
* Procedure: portal vein embolization + major liver resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: h-CCA, type II-IV, T1-3N0-1M0, volume of FLR<40% i-CCA, T1-3N0-1M0, volume of FLR<40% Physical status 1-4 according to American Society of Anesthesiologists Physical Status Classification System BMI up to 40 kg/m2 If cirrhosis is present, class A according to Child-Turcotte-Pugh score Exclusion Criteria: h-CCA, stage 4A, B i-CCA, stage 4B i-CCA, T4N0-1M0 i-CCA, h-CCA with volume of FLR >45% acute cholangitis and/or infected fluid collections, liver abscesses, other unresolved surgical complications of biliary draining procedures. jaundice with total bilirubin >50 µmol/L prior anamnestic allergic reaction or any other sign of intolerance to iodinated contrast media Age under 18 years Age above 80 years Persons who are incapable of giving consent Pregnant or breast-feeding women Physical status >4 according to American Society of Anesthesiologists Physical Status Classification System BMI > 40 kg/m2 If cirrhosis is present, class B, C according to Child-Turcotte-Pugh score

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RALPPS<br>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 | Procedure: RALPPS<br>* 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<br>|
| Portal vein embolization (PVE)<br>Patients with initial volume of FLR < 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma | Procedure: portal vein embolization + major liver resection<br>* PVE on the first stage and major liver resection on the second stage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALPPS, RALPPS, Portal Vein Embolization, Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma