Back to resultsALPPS (Liver Partition and Portal Vein Ligation) for Two-stage Hepatectomy for Colorectal Liver Metastasis
Primary Purpose
Colorectal Cancer
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
two stage hepatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring two stage hepatectomy, liver metastasis, colorectal cancer
Eligibility Criteria
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
Sites / Locations
- Amiens University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
two stage hepatectomy
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
overall mortality
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
the hepatocellular insufficiency is defined by a prothrombin rate below 50%
overall morbidity
the overall morbidity is classified according to the Dindo Clavien classification
preoperative liver volumetry
the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist
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.
Full Information
NCT ID
NCT01842971
First Posted
April 24, 2013
Last Updated
July 31, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT01842971
Brief Title
ALPPS (Liver Partition and Portal Vein Ligation) for Two-stage Hepatectomy for Colorectal Liver Metastasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Main reason: negative echo in the literature after the first publications.
Study Start Date
June 7, 2013 (Actual)
Primary Completion Date
December 13, 2016 (Actual)
Study Completion Date
December 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
two stage hepatectomy, liver metastasis, colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
two stage hepatectomy
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
two stage hepatectomy
Primary Outcome Measure Information:
Title
number of complete surgical procedure
Description
the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.
Time Frame
postoperative week 4
Secondary Outcome Measure Information:
Title
overall mortality
Description
the overall mortality is defined as the number of patients who are dead at one year after the surgery
Time Frame
one year after the two stage hepatectomy
Title
number of patient with hepatocellular insufficiency
Description
the hepatocellular insufficiency is defined by a prothrombin rate below 50%
Time Frame
postoperative day 30
Title
overall morbidity
Description
the overall morbidity is classified according to the Dindo Clavien classification
Time Frame
postoperative day 30
Title
preoperative liver volumetry
Description
the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist
Time Frame
one week prior to the surgery
Title
quality of life
Description
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.
Time Frame
the day before the first stage surgery and the day before the second stage surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean marc regimbeau, MD, PhD
Organizational Affiliation
Amiens University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
ALPPS (Liver Partition and Portal Vein Ligation) for Two-stage Hepatectomy for Colorectal Liver Metastasis
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