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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01842971
• Other study ID #: PI2012_843_0028
• Secondary ID: A41707-36
• Status: Terminated
• Phase: Phase 3
• Start date: June 7, 2013
• Est. completion date: December 13, 2016

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 13, 2016
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• two stage hepatectomy

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of complete surgical procedure	the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.	postoperative week 4
Secondary	overall mortality	the overall mortality is defined as the number of patients who are dead at one year after the surgery	one year after the two stage hepatectomy
Secondary	number of patient with hepatocellular insufficiency	the hepatocellular insufficiency is defined by a prothrombin rate below 50%	postoperative day 30
Secondary	overall morbidity	the overall morbidity is classified according to the Dindo Clavien classification	postoperative day 30
Secondary	preoperative liver volumetry	the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist	one week prior to the surgery
Secondary	quality of life	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.	the day before the first stage surgery and the day before the second stage surgery