Suspended

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

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What is being tested

two stage hepatectomy

Procedure
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire, Amiens
Last updated: August 2, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: June 7, 2013

Actual date on which the first participant was enrolled.

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.

NCT01842971
Principal SponsorCentre Hospitalier Universitaire, Amiens
Last updated: August 2, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

3 inclusion criteria required to participate
older than 18 years old
portal embolisation required
potentially resectable liver metastasis from colorectal cancer
4 exclusion criteria prevent from participating
extra hepatic metastasis
history of hepatectomy
pregnancy or breastfeeding
synchronous surgery on the colon or the rectum

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Amiens University Hospital

Amiens, FranceOpen Amiens University Hospital in Google Maps
SuspendedOne Study Center