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Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Neoplasms

Thank you

Trial Information

Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking


Inclusion Criteria:



- Adult patient

- Affected of hepatic cancerous lesions whatever they are

- Requiring a one or two steps hepatectomy by laparotomy

- ECOG performance status (PS)≤ 2

- Mandatory affiliation to health security insurance

- Written informed consent

Exclusion Criteria:

- With a contraindication or hypersensitivity to ICG administration in medical history

- Having already undergone a major hepatic surgery (more than three segments) or major
biliar surgery (context of major iterative hepatic surgery)

- Unable to be followed during the duration of the study, for social, family,
geographical or psychological reasons

- Pregnant or breast-feeding woman (urinary strip must be negative at the time of the
inclusion in the study for women in age to procreate)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

First step: assess the feasibility and the acceptability of Fluobeam

Outcome Description:

The ability to detect fluorescence The ability to investigate the mobilized parenchyma The ability to use the medical device following requested asepsis procedures Surgeon satisfaction Nurse satisfaction

Outcome Time Frame:

During surgery on day 0

Safety Issue:

No

Principal Investigator

Patrice Peyrat

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard, LYON, FRANCE.

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

HEPATOFLUO

NCT ID:

NCT01738217

Start Date:

January 2013

Completion Date:

August 2014

Related Keywords:

  • Liver Neoplasms
  • Intra-operative imaging
  • NIR Fluorescence
  • Liver surgery
  • Tumoral margins
  • Neoplasms
  • Liver Neoplasms

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