Subserosal carbon nanoparticles for gastrectomy
| ISRCTN | ISRCTN11247387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11247387 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | DANCE-04 |
| Sponsor | Nanjing Drum Tower Hospital |
| Funder | National Natural Science Foundation of China |
- Submission date
- 29/07/2023
- Registration date
- 02/08/2023
- Last edited
- 21/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Lymph node metastasis (tumour spreading into lymph nodes) is common in gastric (stomach) cancer. Extensive lymph node dissection is the fundamental step in radical gastrectomy (complete or near-complete removal of the stomach). Improving the visualization of lymph nodes can help surgeons identify and dissect lymph nodes during surgery. Carbon nanoparticles are an approved drug for visualization. However, it is unclear which approach of administration is best (subserosal injection or submucosal injection, i.e. injected under different layers of tissue). This study is designed to compare the effectiveness and safety of these two approaches in radical gastrectomy.
Who can participate?
Patients between 18 and 75 years old with gastric cancer
What does the study involve?
This study involves radical gastrectomy and the administration of carbon nanoparticles. Participants will be randomly allocated into two groups: Group 1: Subserosal injection of carbon nanoparticles for lymph node visualization. Group 2: Submucosal injection of carbon nanoparticles for lymph node visualization.
What are the possible benefits and risks of participating?
Participants may benefit from an increased number of retrieved lymph nodes from the surgery, which will help with the precise staging of the tumour. Any risks related to the surgery itself (such as bleeding, obstruction, or anastomotic leakage) might occur during this study. There is a very limited risk of participating since this is a safe and approved drug for surgery.
Where is the study run from?
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University (China)
When is the study starting and how long is it expected to run for?
September 2022 to December 2025
Who is funding the study?
National Natural Science Foundation of China
Who is the main contact?
Dr Song Liu, liusong@njglyy.com
Contact information
Principal investigator
321 Zhongshan RD
Nanjing
210008
China
 ORCID ID |
0000-0002-4780-9697 |
|---|---|
| Phone | +86 (0)25 83106666 60931 |
| liusong@njglyy.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized interventional prospective single-center clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy and safety of subserosal carbon nanoparticles navigated radical gastrectomy |
| Study acronym | DANCE-04 |
| Study objectives | Subserosal carbon nanoparticles is safer and more efficient than submucosal carbon nanoparticles in radical gastrectomy |
| Ethics approval(s) |
Approved 08/12/2022, Ethics committee of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School (321 Zhongshan Rd, Nanjing, 210008, China; +86 (0)25 83106666; irb_dth@outlook.com), ref: 2023-372-02 |
| Health condition(s) or problem(s) studied | Radical gastrectomy for patients with gastric cancer |
| Intervention | All participants will be randomized into two groups. Group 1: Subserosal injection of carbon nanoparticles for lymph node visualization. Group 2: Submucosal injection of carbon nanoparticles for lymph node visualization. Method of randomization: simple randomization method using a computer-generated random number to assign each participant to a specific group. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Number of retrieved lymph nodes measured by pathological examination immediately after radical gastrectomy |
| Key secondary outcome measure(s) |
1. Number of metastatic lymph nodes measured by pathological examination immediately after radical gastrectomy |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 99 |
| Key inclusion criteria | 1. Between 18 and 75 years old 2. cT1-4a, cNany, cM0 according to the AJCC classification (version 7.0) before surgery 3. Absence of adjacent organ invasion 4. Performance status (ECOG score) 0 or 1, ASA I-III 5. Consent of participation 6. Distal or total radical gastrectomy |
| Key exclusion criteria | 1. Pregnancy or lactation period 2. Severe mental illness 3. Previous upper abdomen surgery excluding laparoscopic cholecystectomy 4. Previous gastric ESD or EMR history 5. Refusal to laparoscopy 6. Previous iodine allergy 7. Peri-gastric LNs larger than 3cm in preoperative CT or MR 8. Other malignancy in recent 5 years 9. Neoadjuvant therapy for gastric cancer 10. Unstable angina pectoris or myocardial infarction in recent 6 months 11. FEV1 less than 50% of predicted value 12. Systemic corticosteroid therapy in recent 1 month 13. Emergent surgery due to acute bleeding, perforation or obstruction 14. Convert to open surgery 15. Concomitant surgery excluding appendectomy or cholecystectomy |
| Date of first enrolment | 01/08/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Nanjing
210008
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during this study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/05/2025 | 21/05/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/05/2025: Publication reference and total final enrolment added.
01/08/2023: Study's existence confirmed by the ethics committee of Nanjing Drum Tower Hospital.
