3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

— 3D-4K-ICG  

Official title:

Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06161207
• Other study ID #: FUGES-31
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2024
• Est. completion date: January 1, 2029

Study information

• Verified date: December 2023
• Source: Fujian Medical University
• Contact: Mi Lin
• Phone: 13459152658
• Email: silihuala[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.

Description:

1. Research purpose: Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.

2. Research design: Prospective, single-center, randomized controlled, open-control, parallel assignment, superiority test.

2.1 Case group Group A (Study Group 1, 234 cases): ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group B (Study Group 2, 234 cases): ICG near-infrared imaging tracing in ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group C (Control Group 2, 234 cases) 3D laparoscopic gastrectomy with lymph node dissection

2.2 Estimate Sample Size The three-year disease-free survival (DFS) was the main effectiveness evaluation index in this study. The study implemented a superiority test (unilateral), assuming that both the study group's three-year DFS would be better than that of control group, according to previous research results of laparoscopic surgery for locally advanced GC in which the three-year DFS was 65.2%; therefore, the 3-year DFS of the control group would be 65.2%, assuming that the 3-year DFS of the experimental group could be increased by 12% to 77.2%. With an inspection level 0.0125 (unilateral) and an inspection efficiency of 0.8 and using PASS 11 log-rank tests (Lakatos) [Proportion surviving] the calculated sample size was N=211; namely, each group needed 211 people, considering cases of possible exclusion and loss to follow-up (10% drop out rate). The final sample size for each group was 234 cases, for a total of 702 cases.

2.3 randomization After laparoscopic exploration and confirmation that the cases complied with the standards, they were included in the randomized groups in this study. SAS 9.2 was used to produce a serial number ranging from 0001 - 702 corresponding to the treatment allocation, which was reserved in the data center and research center.

2.4 Blinding Method: This research adopts an open design.

2.5 Research cycle: Estimated enrollment cycle: complete enrollment within 2 years. Follow-up period: the enrollment of the first case was the starting point for follow-up. And the enrollment of last case to the postoperative pathology report (generally 2 weeks after surgery) was the endpoint of follow-up for secondary outcomes. Three years after the last case was enrolled was the follow-up endpoint for the main outcomes.

Estimated time: 2023.12-2025.12 (complete enrollment) to 2028.12 (complete follow-up)

Study Objects All patients who meet the inclusion criteria and do not conform to the exclusion criteria are qualified for this study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 702
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2026
• 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. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition

4. No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations

5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale

6. ASA (American Society of Anesthesiology) class I to 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 for laparoscopic cholecystectomy)

4. History of previous gastric surgery (including ESD/EMR for gastric cancer)

5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging

6. Other malignant disease within the past 5 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 for simultaneous surgery for other disease

12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

13. FEV1 (forced expiratory volume in one second)<50% of predicted values

14. Diffuse invasive gastric cancer

15. History of an iodine allergy

16. Patients who declined laparoscopic surgery

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms
• Surgery

Intervention

Procedure:
• Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
Indocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	Disease-free survival is calculated from the day of surgery to the day of recurrence or death	3 years
Secondary	Operation time	Operation time	1 day
Secondary	Total number of retrieved lymph nodes	Total number of retrieved lymph nodes	1 day
Secondary	Noncompliance rate of lymph node dissection	Noncompliance rate of lymph node dissection	1 day
Secondary	Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A	Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A	1 day
Secondary	Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)	Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)	1 day
Secondary	Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)	Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)	1 day
Secondary	Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)	Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)	1 day
Secondary	Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)	Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)	1 day
Secondary	Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B	Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B	1 day
Secondary	Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)	Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)	1 day
Secondary	Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)	Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)	1 day
Secondary	Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)	Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)	1 day
Secondary	Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)	Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)	1 day
Secondary	Number of metastatic lymph nodes	Number of metastatic lymph nodes	1 day
Secondary	Metastasis rate of lymph nodes	Metastasis rate of lymph nodes	1 day
Secondary	Morbidity and mortality rates	Morbidity and mortality rates	30 day
Secondary	3-year overall survival rate	3-year overall survival rate	3 years
Secondary	3-year recurrence pattern	3-year recurrence pattern	3 years
Secondary	Postoperative recovery course	Postoperative recovery course	30 days
Secondary	Intraoperative situation	Intraoperative situation	30 days
Secondary	Postoperative nutritional status	Postoperative nutritional status	3 years
Secondary	Inflammatory and immune response	Inflammatory and immune response	30 days
Secondary	Postoperative quality of life (measured by EQ-5D)	Postoperative quality of life (measured by EQ-5D)	preoperative, postoperative 1 month and postoperative 1 year