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

NCT ID: NCT01842971

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-07

Study Completion Date

2016-12-13

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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

two stage hepatectomy

Intervention Type PROCEDURE

Interventions

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two stage hepatectomy

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jean marc regimbeau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amiens University Hospital

Locations

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Amiens University Hospital

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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A41707-36

Identifier Type: OTHER

Identifier Source: secondary_id

PI2012_843_0028

Identifier Type: -

Identifier Source: org_study_id

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