Fluorescence Lymph Node Mapping for Colon Cancer Surgery
ConditionRight Hemicolectomy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-85
SponsorPusan National University Yangsan Hospital
About this trial
Fluorescence-guided surgery using indocyanine green can visualize the complex and diverse lymph node drainage structures for each patient and help determine the extent of dissection of the D3 lymph node tailored to the patient. However, since fluorescence lymph node mapping (FLNM) is still being conducted only at some institutions for research purposes and is limited to reporting the results of small-scale studies of patients, a large-scale multi-center study was conducted to verify the clinical-oncological effects of FLNM. Research is needed.
Therefore, this study used real-time fluorescence lymph node mapping (FLNM) to determine the extent of D3 lymph node dissection when performing right hemicolectomy and D3 lymph node dissection in patients with locally advanced right-sided colon cancer and to safely remove extensive lymph nodes. We aim to evaluate whether the dissection procedure is safe and beneficial in terms of clinical oncology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who over 19 years old, Under 85 years old
Patient with locally advanced right colon cancer requiring D3 lymphadenectomy
Colon cancer patients diagnosed with clinical stage cT3-4 N0 or cTany N1-2 before surgery
Patient with right-sided colon cancer located in the cecum, ascending colon, flexure colon, and proximal transverse colon.
Disqualifiers
Patients with a history of allergy or side effects to sodium iodine
Patients with colon cancer who have distant or peritoneal metastases
Patients requiring emergency surgery due to colon obstruction or colon perforation
Patients with inflammatory bowel disease not controlled by drug treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Indocyanine green (ICG) injection for intraoperative lymph node imaging
DrugIndocyanine Green (ICG) is used to guide the extent of D3 lymph node dissection during right hemicolectomy. After informed consent, participants randomized to the experimental group undergo bowel preparation and receive an endoscopic submucosal injection of ICG (0.25 mg/ml in saline) at two sites adjacent to the tumor one day prior to surgery. During surgery, near-infrared laparoscopic or robotic imaging systems detect the fluorescence emitted by ICG, guiding targeted D3 lymph node dissection at the origins of the ileocolic artery (ICA) and middle colic artery (MCA).
Standard Right Hemicolectomy (Non-ICG)
Other interventionParticipants in the control group undergo standard right hemicolectomy with D3 lymph node dissection without the use of Indocyanine Green (ICG) or fluorescence imaging. The extent of dissection is determined by conventional anatomical landmarks and the surgeon's clinical judgment.
Treatment groups
186 Participants
are divided into 2 treatment groupsGroup A: FLNM-guided Right HemicolectomyExperimental treatment 1 intervention
Group B: Right HemicolectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pathological D3 lymph node metastasis detection rate
Time frame
From enrollment to within 4 weeks after surgerySecondary outcomes
1
Number of Harvest lymph nodes
Total lymph nodes, lymph nodes near tumor, D3 lymph nodes, ICA/RCA/MCA lymph nodes
Time frame
From enrollment to within 4 weeks after surgery.2
Lymph Node Ratio (LNR)
LNR (lymph node ratio) = number of metastatic lymph nodes / total number of lymph nodes
Time frame
From enrollment to within 4 weeks after surgery.3
Clinicopathological factors associated with FLNM success rate
Gender, age, BMI, pathological stage, tumor size, colon obstruction, etc
Time frame
From enrollment to within 8 weeks after surgery.4
The bleeding rate due to damage to major blood vessels(SMA, SMV) during surgery
Time frame
From enrollment to within 1 week after surgery.Sponsors and contacts
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Source ClinicalTrials.gov