ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer

Study Overview
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Brief Summary
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The study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination

Detailed Description
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In this study 2.5 mg/ml indocyanine green solution is injected subserosally into colonic wall near the tumour in 4 points (1 ml each). The fluorescence is assessed before specimen removal (at least 30 min after injection) and its mesenteric distribution is marked by surgeon on the specimen. Proximal and distal colonic resection margins are chosen to be at least 10 cm long and to include the whole area of fluorescence. After removal, lymphatic node groups according JSCCR are also marked on fresh specimen. During pathological examination each lymph node is assessed not only for presence of metastases but also for its exact location in relation to margins of indocyanine distribution.

Official Title
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ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: lymphatic mapping with indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid) TNM T1-4a N0-2 M0-1 Clinical indications to colonic resection ECOG - 0-2 Signed informed consent. Exclusion Criteria: Medical or psychiatric reasons interfering with patient's decision to participate in the study. Pregnancy or breastfeeding. Medical conditions contraindicating surgical procedure. Acute bowel obstruction, bleeding or perforation. Hypersensitivity to indocyanine green, sodium iodide or iodine Hyperthyroidism or autonomic thyroid adenomas Kidney failure of any aetiology Hepatic failure of any aetiology Poorly tolerated indocyanine injection in the past.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: all study participants are allocated to intraoperative ICG mapping of locoregional lymphatic collector
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional<br>lymphatic mapping by indocyanine green | Procedure: lymphatic mapping with indocyanine green<br>* subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution | number of patients with affected lymph nodes located within ICG distribution margins divided by the number of all patients with pN+ | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events related to ICG lymphatic mapping | proportion of patients facing adverse events related to ICG lymphatic mapping procedure | 30 days | 
| feasibility of ICG lymphatic mapping for colon cancer | proportion of ICG spillage affecting interpretation | duration of surgical procedure | 
| incidence of lymph node metastases outside conventional resection margins (10 cm) | proportion of patients with aberrant lymphatics leading to affected lymph nodes | 30 days | 
| colon cancer lymphatic spread pattern | descriptive data on incidence of D1, D2 and D3 lymphatic collector metastases and frequences of D1 collector metastases depending on distance from primary tumour | 30 days | 
| feasibility of ICG mapping for colon flexure tumours | proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping | duration of surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, lymphatic mapping, indocyanine green