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

Not Applicable
Conditions
Adenocarcinoma of the Esophagogastric Junction
Fluorescence Laparoscopy
Interventions
Procedure: fluorescent laparoscopic radical gastrectomy
Procedure: traditional laparoscopic radical gastrectomy
Registration Number
NCT03647540
Lead Sponsor
Dong Yang
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
164
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.
  1. 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group Ffluorescent laparoscopic radical gastrectomyGroup 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
Group Ltraditional laparoscopic radical gastrectomyGroup 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
Primary Outcome Measures
NameTimeMethod
the number of the dissected lymph nodesin the perioperative period

It includes the total number of the dissected lymph nodes and every group of lymph nodes

Secondary Outcome Measures
NameTimeMethod
3-year disease-free survivalthree years after operation]
cases converted to open surgeryin the perioperative period
the operation timein the perioperative period

The descriptive name of unit would be minute (min).

the incidence of complicationsone month after surgery
the blood loss during the operationin the perioperative period

The descriptive name of unit would be millilitre (ml).

Postoperative recovery of intestinal peristalsisin the perioperative period

The descriptive name of unit would be hour (h).

The mean postoperative hospital stayin the perioperative period

The descriptive name of unit would be day (d).

Trial Locations

Locations (1)

the First Hospital of Jilin University

🇨🇳

Ch'ang-ch'un, Ji Lin, China

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