Subserosal carbon nanoparticles for gastrectomy

Efficacy and safety of subserosal carbon nanoparticles navigated radical gastrectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11247387

Enrollment

100

Registered

2023-08-02

Start date

2023-08-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radical gastrectomy for patients with gastric cancer Cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Number of retrieved lymph nodes measured by pathological examination immediately after radical gastrectomy	—

Secondary

Measure	Time frame
1. 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	—

Measure

Time frame

1. 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

—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026