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

Phase 3

Terminated

• Conditions: Colorectal Cancer
• Interventions: Procedure: two stage hepatectomy

• Registration Number: NCT01842971
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-30
• Study Start: 2013-06-07
• Primary Completion: 2016-12-13
• Study Completion: 2016-12-13
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
two stage hepatectomy	two stage hepatectomy	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

Primary Outcome Measures

Name	Time	Method
number of complete surgical procedure	postoperative week 4	the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, France