Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Study Overview
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Brief Summary
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Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.

Detailed Description
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Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer 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 remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, 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 remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

Official Title
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Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Indocyanine Green Tracer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 75 years Remnant gastric cancer (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 the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Rejection of laparoscopic resection History of allergy to iodine agents Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within the past six months History of unstable angina or myocardial infarction within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for another disease Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of the predicted values Linitis plastica, Widespread

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG<br>Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group) | Drug: Indocyanine Green Tracer<br>* Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer<br>|
| Active Comparator: Non-ICG<br>Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group) | Drug: Indocyanine Green Tracer<br>* Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Retrieved Lymph Nodes | Total Number of Retrieved Lymph Nodes | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node noncompliance rate | Lymph node noncompliance rate | 30 days | 
| Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group | Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group | 30 days | 
| Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate) | Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate) | 30 days | 
| Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate) | Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate) | 30 days | 
| Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate) | Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate) | 30 days | 
| Number of Metastasis Lymph Nodes | Number of Metastasis Lymph Nodes | 30 days | 
| Metastasis rate of lymph node | Metastasis rate of lymph node | 30 days | 
| Postoperative morbidity rate | Postoperative morbidity rate | 30 days | 
| Postoperative mortality rate | Postoperative mortality rate | 30 days | 
| 3-year overall survival rate | 3-year overall survival rate | 3 years | 
| 3-year disease-free survival rate | 3-year disease-free survival rate | 3 years | 
| 3-year recurrence pattern | 3-year recurrence pattern | 3 years | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay | 30 days | 
| Intraoperative situation | Operation time, intraoperative blood loss, and intraoperative morbidity rate | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine Green Tracer, Laparoscopic Gastrectomy, Remnant Gastric Cancer