Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.

N/ACompletedNCT01982227

Centre Hospitalier Universitaire de Saint Etienne10 enrolled

Overview

Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm. Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries. The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated. This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer Metastatic

Interventions

indocyanine greenDRUG

intravenous injection (0.25mg/kg) of the indocyanine green 24h before the surgery.

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection + / - Chemotherapy Hyperthermic Intraperitoneal * Aged 18 to 70 inclusive * Signature information form and consent by the patient Exclusion Criteria: * Pregnant women, a urine pregnancy test or blood will be realized within 72 hours before surgery * Contraindication to surgery * Diagnosis not confirmed colorectal adenocarcinoma * Persons major subject of legal protection or unable to consent

Outcomes

Primary Outcomes

Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo

Time frame: At the end of the surgery

Secondary Outcomes

Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo peritoneal cancer index (PCI) score with and without fluorescence

Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence