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Clinical Trials/NCT01842971
NCT01842971TerminatedPhase 3

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

Centre Hospitalier Universitaire, Amiens2 sites in 1 country3 target enrollmentStarted: June 7, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
3
Locations
2
Primary Endpoint
number of complete surgical procedure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

number of complete surgical procedure

Time Frame: postoperative week 4

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

Secondary Outcomes

  • overall mortality(one year after the two stage hepatectomy)
  • overall morbidity(postoperative day 30)
  • preoperative liver volumetry(one week prior to the surgery)
  • quality of life(the day before the first stage surgery and the day before the second stage surgery)
  • number of patient with hepatocellular insufficiency(postoperative day 30)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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