Right HemicolectomyPhase 2CONSTELLARENCT07060443
Fluorescence Lymph Node Mapping for Colon Cancer Surgery
A Phase 2 study testing Indocyanine green (ICG) injection for intraoperative lymph node imaging and Standard Right Hemicolectomy (Non-ICG) in people with Right Hemicolectomy, run by Pusan National University Yangsan Hospital at 13 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Right Hemicolectomy
- What is being tested?
- Indocyanine green (ICG) injection for intraoperative lymph node imaging and Standard Right Hemicolectomy (Non-ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 23 Jul 2025to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.)
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
South Korea13 sites, 13 recruiting
- Not yet recruiting
Keimyung University Dongsan Medical Center
Daegu
Clinical Research Coordinator, +82-55-360-4835, nasooky1@naver.com
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu
Clinical Research Coordinator, +82-55-360-4835, poison3938@knuh-ext.kr
- Recruiting
Chungnam National University Hospital
Daejeon
Clinical Research Coordinator, +82-42-280-7026, lku111@naver.com
- Not yet recruiting
National Cancer Center Korea
Goyang
Clinical Research Coordinator, +82-55-360-4835, 73454@ncc.re.kr
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun
Clinical Research Coordinator, +82-55-360-4835, pink0869@hanmail.net
- Recruiting
Gachon University Gil Medical Center
Incheon
Clinical Research Coordinator, +82-55-360-4835, jybcolor@gilhospital.com
- Recruiting
Jeonbuk National University Hospital
Jeonju
Clinical Research Coordinator, +82-10-9155-4627, yujin1178@gmail.com
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam
Clinical Research Coordinator, +82-55-360-4835, guswjd531@naver.com
- Recruiting
Asan Medical Center
Seoul
Clinical Research Coordinator, +82-10-2243-2786, ug10124@naver.com
- Not yet recruiting
Korea University Guro Hospital
Seoul
Sub-Investigator, +82-55-360-4835, amsterdam0911@gmail.com
- Not yet recruiting
Kyung Hee University Hospital
Seoul
Sub-Investigator, +82-55-360-4835, ejay.p2018@gmail.com
- Recruiting
St. Vincent's Hospital, The Catholic University of Korea
Suwon
Clinical Research Coordinator, +82-10-2610-2768, moonier0@naver.com
- Recruiting
Pusan National University Yangsan Hospital
Yangsan
Clinical Research Coordinator, +82-55-360-4835, vmffkdl38@naver.com
About this study
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
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.
- Conditions
- Right Hemicolectomy
- Being tested
- Indocyanine green (ICG) injection for intraoperative lymph node imaging, Standard Right Hemicolectomy (Non-ICG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG) injection for intraoperative lymph node imagingDrug
Also called Fluorescence-guided Lymph Node Mapping
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 the origins of the ileocolic artery (ICA) and middle colic artery (MCA).
Standard Right Hemicolectomy (Non-ICG)Other
Also called Conventional Right Hemicolectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| FLNM-guided Right Hemicolectomy | Experimental | FLNM-guided Right Hemicolectomy Receives: Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging |
| Right Hemicolectomy | Active comparator | Standard Right Hemicolectomy without FLNM Receives: Other: Standard Right Hemicolectomy (Non-ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological D3 lymph node metastasis detection rate
Measured: From enrollment to within 4 weeks after surgery
Secondary outcomes (16)
Number of Harvest lymph nodes
Total lymph nodes, lymph nodes near tumor, D3 lymph nodes, ICA/RCA/MCA lymph nodes
Measured: From enrollment to within 4 weeks after surgery.
Lymph Node Ratio (LNR)
LNR (lymph node ratio) = number of metastatic lymph nodes / total number of lymph nodes
Measured: From enrollment to within 4 weeks after surgery.
Clinicopathological factors associated with FLNM success rate
Gender, age, BMI, pathological stage, tumor size, colon obstruction, etc
Measured: From enrollment to within 8 weeks after surgery.
The bleeding rate due to damage to major blood vessels(SMA, SMV) during surgery
Measured: From enrollment to within 1 week after surgery.
Assessment of mesenteric dissection surface quality (3-point scale)
A 3-point scoring system will be used to evaluate the quality of the mesenteric dissection surface following surgery. A higher score reflects a well-preserved mesenteric dissection surface with minimal or no damage.
- 3 points: Complete mesenteric dissection (the dissection surface is intact, with no visible damage, and the peritoneal surface is well preserved)
- 2 points: Nearly complete mesenteric dissection (the dissection surface shows some damage, but there is no exposure of tumor tissue)
- 1 point: Incomplete mesenteric dissection (the dissection surface is damaged, with exposure of tumor tissue within the colonic wall.)
Measured: From enrollment to within 1 week after surgery
Proximal and distal lengths(cm)
Proximal and distal resection lengths
Measured: From enrollment to within 1 week after surgery
Estimated Blood loss(ml)
Measured: On the day of surgery
Operation time(min)
Measured: On the day of surgery
Complications
This outcome measure assesses postoperative complications occurring within 30 days after surgery. Complications are classified according to the Clavien-Dindo classification system, which grades adverse events based on their severity and the type of intervention required. Trained clinical staff will record and categorize complications during the postoperative follow-up period.
Measured: Within 30 days after surgery
Readmission
This outcome measure records whether patients are readmitted to the hospital within 30 days after surgery. In cases of readmission, the reason for readmission will be documented, including complications, treatment-related issues, or other causes as determined by clinical evaluation.
Measured: Within 30 Days After Surgery
Reoperation
This outcome measure records whether patients undergo reoperation within 30 days after the initial surgery. The reasons for reoperation, such as complications or surgical site issues, will be documented based on clinical evaluation.
Measured: Within 30 Days After Surgery
Completeness score of D3 lymph node dissection (3-point scale)
A 3-point scoring system will be used intraoperatively to assess the completeness of D3 lymph node dissection using real-time fluorescence imaging.
Higher scores indicate a more complete lymph node dissection.
- 1 point: Residual fluorescent lymph nodes are present in the D3 area (justification required).
- 2 points: Residual fluorescent lymph nodes are present but resection is deemed unnecessary by the surgeon (e.g., outside D3 area; justification required).
- 3 points: No residual fluorescent lymph nodes remain in the D3 area.
Measured: Assessed on the day of surgery
3year disease-free survival rate
Measured: From enrollment to 3 years after surgery
overall survival rate
Measured: From enrollment to 5 years after surgery
local and systemic recurrence rate
Measured: From enrollment to 3 years after surgery
Surgeon perceptions of FLNM-guided D3 lymphadenectomy
- A custom survey developed by the research team will assess surgeons' perceptions of the usefulness, safety, and potential future application of Fluorescence lymph node mapping (FLNM) guided D3 lymphadenectomy in colorectal cancer surgery. The survey includes Likert-type questions (e.g., "Strongly agree" to "Strongly disagree") and multiple-choice items (e.g., "For which patients is FLNM used?").
- Responses will be reported as the proportion of participants selecting each option for key questions, such as:
- Is FLNM helpful for determining the lymph node dissection range?
- Do you plan to use FLNM in future surgeries?
- Do you believe FLNM helps reduce complications?
- For which patient groups is FLNM currently used?
- The survey will be conducted at two time points: (1) before enrollment of the first subject (after IRB approval), and (2) after enrollment of all subjects has been completed.
Measured: - Before enrollment of the first subject (after IRB approval) - At the end of enrollment of all subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start23 Jul 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right HemicolectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyung Mo Son, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060443
- Sponsor's protocol ID
- 13-2024-001
- Acronym
- CONSTELLARE
- Status last verified
- Jul 2025
- First submitted
- 22 May 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07060443
- Acronym / sponsor ID
- CONSTELLARE / 13-2024-001
- Conditions
- Right Hemicolectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 23 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLNM-guided Right Hemicolectomy | Experimental | Drug: Indocyanine green (ICG) injection for intraoperative lymph node imagingFLNM-guided Right Hemicolectomy |
| Right Hemicolectomy | Active comparator | Other: Standard Right Hemicolectomy (Non-ICG)Standard Right Hemicolectomy without FLNM |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green (ICG) injection for intraoperative lymph node imagingAlso: Fluorescence-guided Lymph Node MappingIndocyanine 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). | Drug | FLNM-guided Right Hemicolectomy |
| Standard Right Hemicolectomy (Non-ICG)Also: Conventional Right HemicolectomyParticipants 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. | Other | Right Hemicolectomy |
Primary outcome
Pathological D3 lymph node metastasis detection rate
Time frame: From enrollment to within 4 weeks after surgery
16 secondary outcomes
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
3year disease-free survival rate
Time frame: From enrollment to 3 years after surgery
overall survival rate
Time frame: From enrollment to 5 years after surgery
local and systemic recurrence rate
Time frame: From enrollment to 3 years after surgery
Surgeon perceptions of FLNM-guided D3 lymphadenectomy
Time frame: - Before enrollment of the first subject (after IRB approval) - At the end of enrollment of all subjects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine green (ICG) injection for intraoperative lymph node imaging and Standard Right Hemicolectomy (Non-ICG) in people with Right Hemicolectomy, run by Pusan National University Yangsan Hospital at 13 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator, PhD (+82-10-7523-8056, skm171@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological D3 lymph node metastasis detection rate (time frame: From enrollment to within 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.