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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Keimyung University Dongsan Medical Center
NOT_YET_RECRUITING
Daegu
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Chungnam National University Hospital
RECRUITING
Daejeon
National Cancer Center Korea
NOT_YET_RECRUITING
Goyang
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Gachon University Gil Medical Center
RECRUITING
Incheon
Jeonbuk National University Hospital
RECRUITING
Jeonju
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Kyung Hee University Hospital
NOT_YET_RECRUITING
Seoul
St. Vincent's Hospital, The Catholic University of Korea
RECRUITING
Suwon
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Contact Information
Primary
Principal Investigator, PhD
skm171@naver.com
+82-10-7523-8056
Backup
Principal Investigator, PhD
skm171@naver.com
+82-55-360-4835
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 186
Treatments
Experimental: FLNM-guided Right Hemicolectomy
FLNM-guided Right Hemicolectomy
Active_comparator: Right Hemicolectomy
Standard Right Hemicolectomy without FLNM
Related Therapeutic Areas
Sponsors
Leads: Pusan National University Yangsan Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials