Clinical trial · Interventional
Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy
A Prospective Randomized Controlled Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Robotic or Laparoscopic Gastrectomy
NCT05229874CI-TRIAL-00070626FUTURE-01unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon nanoparticles | Drug | — | UNRESOLVED |
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carbon nanoparticle suspension injection (CNSI) group
- description
- CNSI (50 mg/dose) was produced by Chongqing Lesmei Pharmaceutical Co., Ltd.: Carbon nanoparticles were marked in the endoscopy division 1 day before surgery, and CNSI was injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.25 ml.
- interventionNames
- Drug: carbon nanoparticles
- type
- ACTIVE_COMPARATOR
- label
- Indocyanine green (ICG) group
- description
- ICG (25 mg/dose) was produced by Dandong Yichuang Pharmaceutical. ICG was marked in the endoscopy division 1 day before surgery and injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.5 ml. Both procedures were performed by a designated medical practitioner.
- interventionNames
- Drug: Indocyanine green
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age from 18 to 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition 4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations 5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) 6. American Society of Anesthesiology score (ASA) class I, II, or III 7. Written informed consent Exclusion Criteria: 1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection 5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 6. History of other malignant disease within past five years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within past six months 9. History of cerebrovascular accident within past six months 10. History of continuous systematic administration of corticosteroids within one month 11. Requirement of simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. FEV1\<50% of predicted values 14. Diffuse; widespread; plastica
References
Publications (2)
- DERIVEDTian Y, Pang Y, Yang P, Guo S, Ma W, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Li Y, Fan L, Zhang Z, Wang D, Zhao X, Tan B, Liu Y, Zhao Q. Effect of carbon nanoparticle suspension injection versus indocyanine green tracer in guiding lymph node dissection during radical gastrectomy (FUTURE-01): a randomized clinical trial. Int J Surg. 2025 Jan 1;111(1):609-616. doi: 10.1097/JS9.0000000000001873. PMID 38954670
- DERIVEDTian Y, Pang Y, Yang P, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Li Y, Fan L, Zhang Z, Zhao X, Tan B, Wang D, Zhao Q. The safety and efficacy of carbon nanoparticle suspension injection versus indocyanine green tracer-guided lymph node dissection during radical gastrectomy (FUTURE-01): A single-center randomized controlled trial protocol. Front Oncol. 2023 Jan 6;12:1044854. doi: 10.3389/fonc.2022.1044854. eCollection 2022. PMID 36686792