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

Gastric Cancer Clinical Trial

— FUTURE-01  

Official title:

A Prospective Randomized Controlled Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Robotic or Laparoscopic Gastrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05229874
• Other study ID #: FUTURE-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 20, 2022
• Est. completion date: January 20, 2025

Study information

• Verified date: October 2023
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: January 20, 2025
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• carbon nanoparticles
Endoscopic injection
• Indocyanine green
Endoscopic injection

Locations

Country	Name	City	State
China	Fourth Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Retrieved Lymph Nodes	Compare total number of retrieved lymph nodes in both group.	10 days
Secondary	The rate of black-stained/fluorescence	The number of black-stained/fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group	10 days
Secondary	Positive rate	The number of positive lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group	10 days
Secondary	False positive rate	The number of negative lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group	10 days
Secondary	Negative rate	The number of negative lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group	10 days
Secondary	False negative rate	The number of positive lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group	10 days
Secondary	Number of Metastasis Lymph Nodes	Compare number of positive lymph nodes in both group.	10 days
Secondary	Morbidity and mortality rates	This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.	30 days
Secondary	3-year disease free survival rate	Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.	36 months
Secondary	3-year recurrence pattern	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.	36 months
Secondary	Intraoperative blood loss	Intraoperative blood loss	1 day
Secondary	Postoperative lymph node anatomy duration	Postoperative lymph node anatomy duration	1 day