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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01842971

Enrollment

Registered

2013-04-30

Start date

2013-06-07

Completion date

2016-12-13

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

two stage hepatectomy, liver metastasis, colorectal cancer

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.

Interventions

PROCEDUREtwo stage hepatectomy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
number of patient with hepatocellular insufficiency	postoperative day 30	the hepatocellular insufficiency is defined by a prothrombin rate below 50%
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026