ALPPS (Liver Partition and Portal Vein Ligation) for Two-stage Hepatectomy for Colorectal Liver Metastasis

Study Overview
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Brief Summary
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The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.

Detailed Description
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In France, each year around 36,000 new cases of colorectal cancers are registered responsible in 16,000 deaths because of liver metastasis. In case of bilobar metastasis, classic two-stage hepatectomy with portal embolization could be performed. An alternative to the classic surgery, early two stage hepatectomy, could be proposed to simplify the patient's management and to improve the resectability.

Official Title
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Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: two stage hepatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: potentially resectable liver metastasis from colorectal cancer portal embolisation required older than 18 years old Exclusion Criteria: synchronous surgery on the colon or the rectum extra hepatic metastasis history of hepatectomy pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: two stage hepatectomy<br>the two stage hepatectomy is defined as a two step procedure: first step: hepatotomy with ligature of the right branch of the portal vein second step (one week after the first step): right hepatectomy | Procedure: two stage hepatectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complete surgical procedure | the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete. | postoperative week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall mortality | the overall mortality is defined as the number of patients who are dead at one year after the surgery | one year after the two stage hepatectomy | 
| number of patient with hepatocellular insufficiency | the hepatocellular insufficiency is defined by a prothrombin rate below 50% | postoperative day 30 | 
| overall morbidity | the overall morbidity is classified according to the Dindo Clavien classification | postoperative day 30 | 
| preoperative liver volumetry | the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist | one week prior to the surgery | 
| quality of life | the quality of life is evaluated thanks to the EORTC QLQ C30 LMC 21 form the day before the first stage surgery and the day before the second stage surgery. | the day before the first stage surgery and the day before the second stage surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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two stage hepatectomy, liver metastasis, colorectal cancer