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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of complete surgical procedure

Outcome Description:

the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.

Outcome Time Frame:

postoperative week 4

Safety Issue:

No

Principal Investigator

jean marc regimbeau, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Amiens University Hospital

Authority:

France: Committee for the Protection of Personnes

Study ID:

PI 2012-843-0028

NCT ID:

NCT01842971

Start Date:

May 2013

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • two stage hepatectomy
  • liver metastasis
  • colorectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

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