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

Not Applicable

• Conditions: Adenocarcinoma of the Esophagogastric Junction; Fluorescence Laparoscopy

• 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

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-08-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17
• Primary Completion: 2020-06-30
• Study Completion: 2022-08-30

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the number of the dissected lymph nodes	in the perioperative period	It includes the total number of the dissected lymph nodes and every group of lymph nodes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Ch'ang-ch'un, Ji Lin, China