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Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)

Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)

Indocyanine green tracer is used to guide laparoscopic D2 lymph node dissection for gastric cancer

ICG near-infrared imaging

Chang-Ming Huang, Pro.

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.

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.

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

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)

Disease-free survival is calculated from the day of surgery to the day of recurrence or death

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.

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 positive lymph nodes in Group A (positive rate)

Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)

Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)

Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)

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.

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.

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

Postoperative nutritional status and quality of life

Fujian Medical University

Professor

Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection

Indocyanine Green Tracer Using in Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection

3D 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

Mi Lin

Hua-Long Zheng

Chang-ming Huang

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.

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.

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

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

Noncompliance rate of lymph node dissection

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 positive lymph nodes in Group B (positive rate)

Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)

Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)

Postoperative quality of life (measured by EQ-5D)

Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma.

Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer

Indocyanine Green

Chang-Ming Huang, MD

Zu-Kai Wang, MD

Chang-Ming Huang, Huang

This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.

After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.

Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer

The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes

The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes

The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes

The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes

Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.

This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

Time to first ambulation in hours is used to assess the postoperative recovery course.

Time to first flatus in days is used to assess the postoperative recovery course.

Time to first liquid diet in days is used to assess the postoperative recovery course.

Time to first soft diet in days is used to assess the postoperative recovery course.

Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.

Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.

Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer

Indocyanine Green Tracer

Changming Huang, Professor

The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma.

On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.

Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer

Compare total number of retrieved lymph nodes in both group.

The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group

The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group

The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group

Compare number of positive lymph nodes in both group.

Compare metastasis rate of lymph node in both group

disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.

The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.

The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.

The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

Overall survival was defined as the time from surgery to death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Indocyanine Green Tracer Using in Laparoscopic Radical Gastrectomy for Locally Advanced Gastric Cancer	NCT04593615	Gastric Cancer Surgery	ICG near-infrar...	18 Years - 75 Years	Fujian Medical University
3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer	NCT06161207	Gastric Cancer Surgery	Indocyanine Gre...	18 Years - 75 Years	Fujian Medical University
Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer	NCT04973475	Early Gastric C... Indocyanine Gre... Lymph Node Diss...	Indocyanine Gre...	18 Years - 75 Years	Fujian Medical University
Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer	NCT04973475	Early Gastric C... Indocyanine Gre... Lymph Node Diss...	Indocyanine Gre...	18 Years - 75 Years	Fujian Medical University
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection	NCT03050879	Stomach Neoplas... Indocyanine Gre...	Indocyanine Gre...	18 Years - 75 Years	Fujian Medical University
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection	NCT03050879	Stomach Neoplas... Indocyanine Gre...	Indocyanine Gre...	18 Years - 75 Years	Fujian Medical University

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