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

N.N. Petrov National Medical Research Center of Oncology108 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

108

Conditions

Colon Cancer

Interventions

lymphatic mapping with indocyanine greenPROCEDURE

subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid) 2. TNM T1-4a N0-2 M0-1 3. Clinical indications to colonic resection 4. ECOG - 0-2 5. Signed informed consent. Exclusion Criteria: 1. Medical or psychiatric reasons interfering with patient's decision to participate in the study. 2. Pregnancy or breastfeeding. 3. Medical conditions contraindicating surgical procedure. 4. Acute bowel obstruction, bleeding or perforation. 5. Hypersensitivity to indocyanine green, sodium iodide or iodine 6. Hyperthyroidism or autonomic thyroid adenomas 7. Kidney failure of any aetiology 8. Hepatic failure of any aetiology 9. Poorly tolerated indocyanine injection in the past.

Locations (1)

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, Russia

Outcomes

Primary Outcomes

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+

Time frame: 30 days

Secondary Outcomes

incidence of adverse events related to ICG lymphatic mapping

proportion of patients facing adverse events related to ICG lymphatic mapping procedure

Time frame: 30 days

feasibility of ICG lymphatic mapping for colon cancer

proportion of ICG spillage affecting interpretation

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: duration of surgical procedure

Data from ClinicalTrials.gov

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