ISRCTN ISRCTN11247387
DOI https://doi.org/10.1186/ISRCTN11247387
Secondary identifying numbers DANCE-04
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Song Liu
Principal Investigator

321 Zhongshan RD
Nanjing
210008
China

ORCiD logoORCID ID 0000-0002-4780-9697
Phone +86 (0)25 83106666 60931
Email liusong@njglyy.com

Study information

Study designRandomized interventional prospective single-center clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment, Safety, Efficacy
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEfficacy and safety of subserosal carbon nanoparticles navigated radical gastrectomy
Study acronymDANCE-04
Study objectivesSubserosal 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) studiedRadical gastrectomy for patients with gastric cancer
InterventionAll 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 typeProcedure/Surgery
Primary outcome measureNumber of retrieved lymph nodes measured by pathological examination immediately after radical gastrectomy
Secondary outcome measures1. Number of metastatic lymph nodes measured by pathological examination immediately after radical gastrectomy
2. Sensitivity and specificity of carbon nanoparticles staining for the diagnosis of metastatic lymph nodes, measured by pathological examination immediately after radical gastrectomy
3. 3-year disease-free survival (DFS), 3-year relapse-free survival (RFS), 3-year overall survival (OS), measured by outpatient clinic or telephone follow-up at 3 years after surgery
4. Postoperative complications measured by Clavien-Dindo classification at 1, 3, and 7 days after surgery
Overall study start date01/09/2022
Completion date31/12/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants100
Total final enrolment99
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2023
Date of final enrolment31/12/2024

Locations

Countries of recruitment

  • China

Study participating centre

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
321 Zhongshan Rd
Nanjing
210008
China

Sponsor information

Nanjing Drum Tower Hospital
Hospital/treatment centre

321 Zhongshan Rd
Nanjing
210008
China

Phone +86 (0)25 83106666
Email irb_dth@outlook.com
Website http://www.njglyy.com/en/
ROR logo "ROR" https://ror.org/026axqv54

Funders

Funder type

Government

National Natural Science Foundation of China
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 date31/12/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe 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

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.