The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction

Study Overview
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Brief Summary
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The fluorescent laparoscopic technique would be applied to the radical resection of gastric cancer at the junction of esophagus and stomach, and compared with the traditional laparoscopic radical resection of gastric cancer to find a better surgical method for patients

Official Title
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The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction

Conditions
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Adenocarcinoma of the Esophagogastric Junction, Fluorescence Laparoscopy

Intervention / Treatment
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* Procedure: fluorescent laparoscopic radical gastrectomy
* Procedure: traditional laparoscopic radical gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1. All cases should be diagnosed as adenocarcinoma of the esophagogastric junctionncer by histology. The tumor is within 1 cm above or 2 cm below the anatomic cardia. The clinical stage is T1-3, Nx, M0 for gastric cancer which can undergo the laparoscopic surgery. 2. Eastern Cooperative Oncology Group (ECOG) scale 0-2 3. Heart, lung, liver, and kidney function can tolerate operation 4. Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent. Exclusion Criteria: 1. history of stomach malignant disease 2. recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin) 3. patients with obstruction, perforation, bleeding requiring emergency surgery 4. a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases 5. combined stomach multiple carcinomas 6. with a history of serious mental illness 7. pregnant or lactating women 8. The researchers believe that the patients are unsuitable to participate in the researchers with other cases. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group F<br>Group F received endoscopic submucosal injection of indocyanine green (ICG) 2 hours before operation, followed by fluorescent laparoscopic radical gastrectomy. All specimens were grouped for lymph node collection, and the postoperative management was unified according to enhanced recovery after surgery (ERAS). All basic clinical and pathological data were statistically analyzed | Procedure: fluorescent laparoscopic radical gastrectomy<br>* The gastrectomy for group F would be underwent by the fluorescence laparoscopy. All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.<br>|
| Active Comparator: Group L<br>Group L received traditional laparoscopic radical gastrectomy. All specimens were grouped for lymph node collection, and the postoperative management was unified according to enhanced recovery after surgery (ERAS). All basic clinical and pathological data were statistically analyzed | Procedure: traditional laparoscopic radical gastrectomy<br>* The gastrectomy for group L would be underwent by the laparoscopy.All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of the dissected lymph nodes | It includes the total number of the dissected lymph nodes and every group of lymph nodes | in the perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival |  | three years after operation] | 
| the incidence of complications |  | one month after surgery | 
| the operation time | The descriptive name of unit would be minute (min). | in the perioperative period | 
| the blood loss during the operation | The descriptive name of unit would be millilitre (ml). | in the perioperative period | 
| Postoperative recovery of intestinal peristalsis | The descriptive name of unit would be hour (h). | in the perioperative period | 
| cases converted to open surgery |  | in the perioperative period | 
| The mean postoperative hospital stay | The descriptive name of unit would be day (d). | in the perioperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluorescence laparoscopy, adenocarcinoma of the esophagogastric junction (AEG)