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Recruiting NCT07060443

Fluorescence Lymph Node Mapping for Colon Cancer Surgery

Phase II Interventional Right Hemicolectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indocyanine green (ICG) injection for intraoperative lymph node imaging, Standard Right Hemicolectomy (Non-ICG).
Who it may be relevant to
Registry conditions: Right Hemicolectomy. Basic parameters: 19 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinico-oncological Safety and Efficacy of Real-time Fluorescence Lymph Node Mapping (FLNM) in Laparoscopic and Robotic Right Hemicolectomy for Patients With Locally Advanced Right-sided Colon Cancer; Multicenter Phase II Open Labelled Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Indocyanine green (ICG) injection for intraoperative lymph node imaging
    Indocyanine 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
  • Other Standard Right Hemicolectomy (Non-ICG)
    Participants 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.

Primary outcome measures

  • Pathological D3 lymph node metastasis detection rate [Time frame: From enrollment to within 4 weeks after surgery]
Secondary outcome measures (12)
  • Number of Harvest lymph nodes [Time frame: From enrollment to within 4 weeks after surgery.]
  • Lymph Node Ratio (LNR) [Time frame: From enrollment to within 4 weeks after surgery.]
  • Clinicopathological factors associated with FLNM success rate [Time frame: From enrollment to within 8 weeks after surgery.]
  • The bleeding rate due to damage to major blood vessels(SMA, SMV) during surgery [Time frame: From enrollment to within 1 week after surgery.]
  • Assessment of mesenteric dissection surface quality (3-point scale) [Time frame: From enrollment to within 1 week after surgery]
  • Proximal and distal lengths(cm) [Time frame: From enrollment to within 1 week after surgery]
  • Estimated Blood loss(ml) [Time frame: On the day of surgery]
  • Operation time(min) [Time frame: On the day of surgery]
  • Complications [Time frame: Within 30 days after surgery]
  • Readmission [Time frame: Within 30 Days After Surgery]
  • Reoperation [Time frame: Within 30 Days After Surgery]
  • Completeness score of D3 lymph node dissection (3-point scale) [Time frame: Assessed on the day of surgery]

Eligibility criteria

Inclusion criteria

  • 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.
  • Patients with American Society of Anesthesiology (ASA) I-III
  • Patients who agreed to the research purpose and voluntarily gave informed consent

Exclusion criteria

  • 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
  • Patients with concurrent cancer in other areas other than colon cancer
  • Patients with a history of hereditary disease or coagulopathy at risk of bleeding
  • Women who are pregnant or may be pregnant and lactating women
  • Patients with chronic renal failure (e-GFR < 15) or patients receiving dialysis at the time of screening
  • Patients diagnosed with liver failure or with decreased consciousness due to hepatic encephalopathy
  • Patients judged to have difficulty in smooth lymph perfusion due to heart disease (acute myocardial infarction, acute and chronic heart failure) within the past 6 months
  • Patients unable to undergo general anesthesia
  • Patients with American Society of Anesthesiology (ASA) IV or V
  • Patients who do not wish to participate in this study
  • Patients who are judged by the researcher to be unsuitable for participation in this clinical trial (Example: People with a life expectancy of less than 6 months, people expected to have low compliance with clinical trials, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

South Korea · 13 centers
  • Keimyung University Dongsan Medical Center — Daegu
  • Kyungpook National University Chilgok Hospital — Daegu
  • Chungnam National University Hospital — Daejeon
  • National Cancer Center Korea — Goyang
  • Chonnam National University Hwasun Hospital — Hwasun
  • Gachon University Gil Medical Center — Incheon
  • Jeonbuk National University Hospital — Jeonju
  • Seoul National University Bundang Hospital — Seongnam
  • … and 5 more centers

Identifiers

NCT: NCT07060443 · 13-2024-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗