Indocyanine Green Tracer Using in Laparoscopic Radical Gastrectomy for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— CLASS-11  

Official title:

Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer (CLASS-11)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04593615
• Other study ID #: CLASS-11
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: August 17, 2028

Study information

• Verified date: April 2024
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with locally advanced gastric adenocarcinoma (CT2-4a N0/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer by comparing injection ICG group and non-injection ICG group.

Description:

1. Research purpose Patients with locally advanced gastric adenocarcinoma (cT2-4a, N0/+, M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 LND for GC by comparing an injection ICG group and a non-injection ICG group.

2. Research design Prospective, multicenter, randomized controlled, open-control, parallel assignment, superiority test. ClinicalTrials.gov: NCT04593615. IRB number: 2020YF028-01 2.1 multicenter This study was conducted in 15 centers, including Fujian Medical University Union Hospital; Peking University Cancer Hospital and Institute; Zhongshan Hospital, Fudan University; Teaching Hospital of Putian First Hospital of Fujian Medical University; Zhangzhou Affiliated Hospital of Fujian Medical University; The First Hospital of Jilin University; Southern Medical University Nanfang Hospital; The First Affiliated Hospital of Nanjing Medical University; Affiliated Hospital of Qinghai University; Qilu Hospital of Shandong University; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tangdu Hospital, Fourth Military Medical University; Tianjin Medical University Cancer Institute and Hospital; Cancer Hospital, Chinese Academy of Medical Sciences; and Sun Yat-Sen University Cancer Center.

2.2 Case Group Group A (Study Group, 535 cases): Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group) Group B (Control Group, 535 cases): Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group) 2.3 Estimate Sample Size The three-year disease-free survival (DFS) was this study's main effectiveness evaluation index. The study implemented a superiority test (unilateral), assuming that the study group's three-year DFS would be better than that of the control group,23, 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 9% to 74.2%. With an inspection level of 0.025 (unilateral) and an inspection efficiency of 0.9 and using PASS 11 log-rank tests (Lakatos) [Proportion surviving] the calculated sample size was N=428; namely, each group needed 428 people, considering cases of possible exclusion and loss to follow-up (20% drop out rate). The final sample size for each group was 535 cases, for 1070 cases. Approximately 62-63 cases were initially assigned to each center.

2.4 randomization After laparoscopic exploration and confirmation that the cases complied with the standards, they were included in the randomized groups in this study. We adopted the central dynamic layered segment randomization method, with control factors including age, gender, tumor location, clinical staging, research center of the given seed number, and segment length. SAS 9.2 produced a serial number ranging from 0001 - 1070 corresponding to the treatment allocation, which was reserved in the data center and research center. Each center had a specialist who sent the patients' information (age, sex, tumor location, clinical staging, and research center) to the randomization implementation department of the data center via email, telephone call, or text message, and the central randomization department analyzed this information to determine the case enrollment and inform the research center.

2.5 Blinding Method: This research adopts an open design. 2.6 Research cycle: Estimated enrollment cycle: complete enrollment within 2 years. Follow-up period: Enrolling the first case was the starting point for follow-up. and the enrollment of the last case to the postoperative pathology report (generally 2 weeks after surgery) was the endpoint of follow-up for secondary outcomes. The follow-up endpoint for the main outcomes was three years after the last case was enrolled.

Estimated time: 2020.11-2022.10 (complete enrollment) to 2025.10 (complete follow-up)

3. 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: Active, not recruiting
• Enrollment: 1070
• Est. completion date: August 17, 2028
• Est. primary completion date: August 17, 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 including enlarged or bulky No.10 lymph nodes

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. Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum

16. History of an iodine allergy

17. Patients who declined laparoscopic surgery

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms
• Surgery

Intervention

Procedure:
• ICG near-infrared imaging
Indocyanine green tracer is used to guide laparoscopic D2 lymph node dissection for gastric cancer

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

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	Total number of retrieved lymph nodes	Total number of retrieved lymph nodes	30 days
Secondary	Noncompliance rate of lymph node dissection	The LN dissection rate was determined by the number of patients in whom a LN station was harvested divided by the total number of patients who required retrieval at the corresponding LN station. Within the scope of D2 dissection, LN noncompliance was defined as the absence of LNs that should have been resected from > 1 LN station.	30 days
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	30 days
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)	30 days
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)	30 days
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)	30 days
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)	30 days
Secondary	Number of metastatic lymph nodes	Number of metastatic lymph nodes	30 days
Secondary	Metastasis rate of lymph nodes	Metastasis rate of lymph nodes	30 days
Secondary	Postoperative complications	Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.	30 days
Secondary	Mortality rates	Patient died during hospitalization.	30 days
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	Time to first flatus after surgery, time to first ambulation after surgery, time to first liquid diet after surgery, time to first semi-liquid diet after surgery, length of hospital stay after surgery.	30 days
Secondary	The incidence of intraoperative complications	Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications	30 days
Secondary	Postoperative nutritional status and quality of life	Postoperative nutritional status and quality of life	3 years
Secondary	Inflammatory and immune response	Inflammatory and immune response	3 years