Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional | Experimental | lymphatic mapping by indocyanine green |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lymphatic mapping with indocyanine green | Procedure | subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aleksey Karachun, PhD | N.N. Petrov National Medicine Research Center of oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Petrov National Medical Research Center of Oncology | Saint Petersburg | 192289 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41099883 | Derived | Panaiotti L, Karachun A, Muravtseva A, Golovanova T, Khaetskaya M, Shkatov M, Petrov A. Indocyanine green (ICG) fluorescence guided lymph node mapping for determination of resection margins in colon cancer - ISCAPE trial. Tech Coloproctol. 2025 Oct 16;29(1):179. doi: 10.1007/s10151-025-03222-3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
all study participants are allocated to intraoperative ICG mapping of locoregional lymphatic collector
Not provided
Not provided
Not provided
Not provided
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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |