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

Dong Yang

Status: Unknown

Conditions: Fluorescence Laparoscopy; Adenocarcinoma of the Esophagogastric Junction

Treatments: Procedure: traditional laparoscopic radical gastrectomy; Procedure: fluorescent laparoscopic radical gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03647540

130020

Details and patient eligibility

About

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

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Group F

Experimental group

Description:

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

Treatment:

Procedure: fluorescent laparoscopic radical gastrectomy

Group L

Active Comparator group

Description:

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

Treatment:

Procedure: traditional laparoscopic radical gastrectomy