Status:
UNKNOWN
Study to Evaluate a High Intensity Focused Ultrasound (HIFU) Procedure in Patient With Liver Metastases
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
National Cancer Institute, France
Cancéropôle Lyon Auvergne Rhône-Alpes
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the feasibility, safety and efficacy of High Intensity Focused Ultrasound (HIFU) patients undergoing hepatectomy for colorectal liver metastases. This is a phase...
Detailed Description
Justification and interest of the study: Colorectal liver metastases (CLM) are a major public health issue (16 000 deaths each year in France). To date, complete resection of CLM offers the only pote...
Eligibility Criteria
Inclusion
- 18 years old or more patient,
- Affected of hepatic metastasis of a colorectal cancer,
- Who must undergo a hepatectomy by laparotomy with the aim of the resection of hepatic metastasis,
- ECOG performance status (PS) = 1,
- Mandatory affiliation to a health security insurance,
- Written informed consent.
Exclusion
- Having already undergone a major hepatic surgery (more than three segments) or biliary major (context of major iterative hepatic surgery),
- Having already undergone a major abdominal surgery with the exception of a colorectal surgery for the treatment of its primitive tumor (the surgery of the gall-bladder by laparoscopy for the deadline upper to 6 months do not constitute a criterion of not inclusion),
- Unable to be followed during the duration of the study,
- Pregnant or breast-feeding woman (a pregnancy test must be negative at the time of the inclusion in the study for the women in age to procreate; a method of reliable contraception must be used during the duration of the study).
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01489787
Start Date
March 1 2010
End Date
December 1 2019
Last Update
January 29 2018
Active Locations (1)
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1
Centre Léon Bérard
Lyon, France, 69373