Fluorescence-guided lymphatic mapping in colorectal cancer
| ISRCTN | ISRCTN16454797 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16454797 |
| Secondary identifying numbers | 2018PHB052-01 |
- Submission date
- 17/06/2025
- Registration date
- 17/06/2025
- Last edited
- 17/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Colorectal cancer is one of the most common types of cancer around the world. During surgery to remove the cancer, doctors also take out nearby lymph nodes to check if the cancer has spread. This helps guide further treatment. The study looked at whether using a special fluorescent dye called indocyanine green (ICG) during surgery could help doctors find and remove more lymph nodes compared to standard surgery without the dye.
Who can participate?
Patients who were diagnosed with left-sided colorectal cancer and were scheduled for planned (elective) surgery at Peking University People’s Hospital between April 2018 and January 2020 were eligible to take part.
What does the study involve?
Participants had one of two types of surgery:
-One group had standard keyhole (laparoscopic) surgery.
-The other group had the same surgery, but with the addition of ICG dye. The dye made the lymphatic system glow under a special camera, helping surgeons see and remove lymph nodes more clearly.
Doctors then compared the number of lymph nodes removed and other surgical outcomes between the two groups.
What are the possible benefits and risks of participating?
Using ICG may help surgeons remove more lymph nodes accurately, which could improve cancer treatment and outcomes. The dye is generally very safe, with only a small chance of allergic reactions or other side effects. All procedures were part of standard medical care.
Where is the study run from?
Peking University People’s Hospital in Beijing, China.
When is the study starting and how long is it expected to run for?
August 2018 to January 2020.
Who is funding the study?
The study was supported by the National Natural Science Foundation of China, along with other institutional and regional funding sources.
Who is the main contact?
Dr Yudi Bao, ydbao@pku.edu.cn
Contact information
Public, Scientific
Xizhimen#11, Xicheng District
Beijing
100044
China
 ORCID ID |
0000-0002-1914-371X |
|---|---|
| Phone | +86 13810355879 |
| ydbao@pku.edu.cn |
Principal Investigator
Xizhimen#11, Xicheng District
Beijing
100044
China
| Phone | +86 88326600 |
|---|---|
| shenzhanlong@pkuph.edu.cn |
Study information
| Study design | Prospective comparative cohort study with propensity score matching |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Scientific title | Indocyanine green fluorescence-guided lymphatic mapping and navigated lymphadenectomy in colorectal cancer |
| Study objectives | We hypothesize that indocyanine green (ICG) fluorescence-guided lymphatic mapping and navigated lymphadenectomy improves the accuracy and completeness of lymph node dissection in left-sided colorectal cancer surgery compared to conventional laparoscopic approaches, potentially leading to improved oncological outcomes and more precise anatomical localization of lymphatic drainage. |
| Ethics approval(s) |
Approved 28/02/2018, Ethical Review Committee of Peking University People’s Hospital (Xizhimen #11, Xicheng District, Beijing, 100044, China; +86 88324516; rmyyllwyh@163.com), ref: 2018PHB052-01 |
| Health condition(s) or problem(s) studied | ICG-guided lymphadenectomy in left-sided colorectal cancer |
| Intervention | • ICG-Guided Group (Experimental Arm): Patients received real-time indocyanine green (ICG) near-infrared fluorescence imaging-guided central lymph nodes mapping and dissection during laparoscopic radical resection. ICG was injected into the submucosa around the tumor one day before surgery via colonoscopy. Lymphatic drainage was visualized intraoperatively with a fluorescence camera. • Control Group (Standard Arm): Patients underwent conventional laparoscopic radical resection without the use of ICG guidance. • Intervention Duration: The surgery was conducted as a one-time procedure. • Follow-up: All patients were followed up for a minimum of 36 months postoperatively to monitor recurrence and survival outcomes. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Indocyanine green fluorescence mapping |
| Primary outcome measure | Number of central lymph nodes harvested, measured by pathological examination of surgical specimens postoperatively at day 0 |
| Secondary outcome measures | 1. Total number of lymph nodes retrieved, measured via pathological analysis (postoperative day 0) 2. Surgical safety, assessed by intraoperative and postoperative complication rate within 30 days, based on clinical records and follow-up visits 3. 3-year disease-free survival (DFS), measured by clinical and radiological follow-up at regular intervals (every 3–6 months) 4. 3-year overall survival (OS), assessed through hospital records and follow-up calls at 36 months |
| Overall study start date | 01/08/2018 |
| Completion date | 31/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 251 |
| Key inclusion criteria | 1. Age between 18 and 85 years 2. Pathologically confirmed left-sided colon or rectal adenocarcinomas 3. Legal competence |
| Key exclusion criteria | 1. Coexisting untreated malignancies 2. Medically contraindications to laparoscopic surgery 3. Known allergy to ICG or iodine 4. Impaired liver function |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 31/01/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100044
China
Sponsor information
Hospital/treatment centre
Xizhimen#11, Xicheng District
Beijing
100044
China
| Phone | +86 88326600 |
|---|---|
| shenzhanlong@pkuph.edu.cn | |
| Website | http://www.pkuph.cn/ |
"ROR" |
https://ror.org/035adwg89 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. ydbao@pku.edu.cn |
Editorial Notes
17/06/2025: Trial's existence confirmed by Ethical Review Committee of Peking University People’s Hospital.
