Clinical trial NCT05468827: ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
Official title: ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: colon cancer
lymphatic mapping
indocyanine green
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all study participants are allocated to intraoperative ICG mapping of locoregional lymphatic collector
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution
timeFrame: 30 days
Secondary outcomes:
measure: incidence of adverse events related to ICG lymphatic mapping
timeFrame: 30 days
measure: feasibility of ICG lymphatic mapping for colon cancer
timeFrame: duration of surgical procedure
measure: incidence of lymph node metastases outside conventional resection margins (10 cm)
timeFrame: 30 days
measure: colon cancer lymphatic spread pattern
timeFrame: 30 days
measure: feasibility of ICG mapping for colon flexure tumours
timeFrame: duration of surgical procedure
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov National Medical Research Center of Oncology
Study officials:
affiliation: N.N. Petrov National Medicine Research Center of oncology
name: Aleksey Karachun, PhD
role: STUDY_DIRECTOR
References: