Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy

NCT ID: NCT05229874

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2025-01-20

Brief Summary

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

Detailed Description

Da Vinci robot surgery XI system has fluorescence imaging function, which can realize indocyanine green lymph node tracking navigation technology in the operation. At the same time, the lymph node tracking effect of nano carbon suspension injection is not affected by equipment. The flexible mechanical arm of Da Vinci robot combined with the application of lymph node tracing technology makes the lymph node dissection of gastric cancer surgery more thorough, and also reduces the difficulty of surgery. Indocyanine green navigational lymphadenectomy can also be performed by fluorescence laparoscopy. By comparing the two tracer techniques, the lymph node tracer technique which is more suitable for robot or laparoscopic surgery system is selected to provide help and choice for clinical surgeons.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carbon nanoparticle suspension injection (CNSI) group

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.

Group Type: EXPERIMENTAL

carbon nanoparticles

Intervention Type: DRUG

Endoscopic injection

Indocyanine green (ICG) group

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.

Group Type: ACTIVE_COMPARATOR

Indocyanine green

Intervention Type: DRUG

Endoscopic injection

Interventions

carbon nanoparticles

Endoscopic injection

Intervention Type: DRUG

Indocyanine green

Endoscopic injection

Intervention Type: DRUG

Other Intervention Names

carbon nanoparticle suspension injection; ICG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qun Zhao

Role: STUDY_CHAIR

Departments of Third Surgery, Fourth Hospital of Hebei Medical University

Locations

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

References

Tian 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.

Reference Type: DERIVED

PMID: 38954670 (View on PubMed)

Tian 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.

Reference Type: DERIVED

PMID: 36686792 (View on PubMed)

Other Identifiers

FUTURE-01

Identifier Type: -

Identifier Source: org_study_id