N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 192289, Russia
NCT Number: NCT05468827
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Saint Petersburg, 192289, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics
Time frame: 30 days
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
proportion of patients facing adverse events related to ICG lymphatic mapping procedure
Time frame: duration of surgical procedure
proportion of ICG spillage affecting interpretation
Time frame: 30 days
proportion of patients with aberrant lymphatics leading to affected lymph nodes
Time frame: 30 days
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: duration of surgical procedure
proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping
N.N. Petrov National Medical Research Center of Oncology
Other
Acronym: ISCAPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07736131
Colon Cancer, Colonic Diseases
View Trial DetailsNCT05513742
Colon Cancer, Colonic Diseases
Hot Springs, Arkansas, United States
View Trial DetailsNCT07725692
Anastomotic Leak, Colon Cancer
Alexandria, Please Select, Egypt
View Trial DetailsNCT05538195
Colon Cancer, Colonic Diseases
Henan, China
View Trial Details