NCT03647540UnknownNot Applicable
The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction
Dong Yang2 sites in 1 country164 target enrollmentStarted: August 30, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 164
- Locations
- 2
- Primary Endpoint
- the number of the dissected lymph nodes
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Eastern Cooperative Oncology Group (ECOG) scale 0-2
- •Heart, lung, liver, and kidney function can tolerate operation
- •Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
Exclusion Criteria
- •history of stomach malignant disease
- •recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
- •patients with obstruction, perforation, bleeding requiring emergency surgery
- •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
- •combined stomach multiple carcinomas
- •with a history of serious mental illness
- •pregnant or lactating women
- •The researchers believe that the patients are unsuitable to participate in the researchers with other cases.
Outcomes
Primary Outcomes
the number of the dissected lymph nodes
Time Frame: in the perioperative period
It includes the total number of the dissected lymph nodes and every group of lymph nodes
Secondary Outcomes
- 3-year disease-free survival(three years after operation])
- cases converted to open surgery(in the perioperative period)
- the incidence of complications(one month after surgery)
- the blood loss during the operation(in the perioperative period)
- the operation time(in the perioperative period)
- Postoperative recovery of intestinal peristalsis(in the perioperative period)
- The mean postoperative hospital stay(in the perioperative period)
Investigators
Dong Yang
Doctor
Jilin University
Study Sites (2)
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