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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Early Gastric Cancer, Indocyanine Green, Lymph Node Dissection

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) American Society of Anesthesiology score (ASA) class I, II, or III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection 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 past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer Forced expiratory volume in 1 second (FEV1)<50% of predicted values Rejection of laparoscopic resection Preoperatively confirmed tumors invading the dentate line or duodenum History of allergy to iodine agents Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Indocyanine Green Tracer<br>Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma. | Drug: Indocyanine Green<br>* Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate | The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes | One month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True positive rate | The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes | One month after surgery | 
| False positive rate | The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes | One month after surgery | 
| True negative rate | The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes | One month after surgery | 
| Total number of retrieved lymph nodes | Total number of retrieved lymph nodes | One month after surgery | 
| Lymph node noncompliance rate | 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. | One month after surgery | 
| Number of Metastasis Lymph Nodes | Number of Metastasis Lymph Nodes | One month after surgery | 
| Metastasis rate of lymph node | Metastasis rate of lymph node | One month after surgery | 
| Morbidity and mortality rates | This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery. | One month after surgery | 
| 3-year overall survival rate | 3-year overall survival rate | 36 months | 
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months | 
| 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 | 
| Intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day | 
| Time to first ambulation | Time to first ambulation in hours is used to assess the postoperative recovery course. | 30 days | 
| Time to first flatus | Time to first flatus in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first liquid diet | Time to first liquid diet in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first soft diet | Time to first soft diet in days is used to assess the postoperative recovery course. | 30 days | 
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days | 
| The variation of white blood cell count | 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. | Preoperative 3 days and postoperative 1, 3, and 5 days | 
| The variation of hemoglobin | 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. | Preoperative 3 days and postoperative 1, 3, and 5 days | 
| The variation of C-reactive protein | The variation of C-reactive protein | Preoperative 3 days and postoperative 1, 3, and 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasms, Indocyanine Green Tracer, Laparoscopic Distal Gastrectomy, Lymph Node Dissection