Clinical trial NCT03647540: The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction
Official title: The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fluorescence Laparoscopy
Adenocarcinoma of the Esophagogastric Junction
Keywords: fluorescence laparoscopy
adenocarcinoma of the esophagogastric junction (AEG)
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

-

Primary outcomes:
measure: the number of the dissected lymph nodes
timeFrame: in the perioperative period
Secondary outcomes:
measure: 3-year disease-free survival
timeFrame: three years after operation]
measure: the incidence of complications
timeFrame: one month after surgery
measure: the operation time
timeFrame: in the perioperative period
measure: the blood loss during the operation
timeFrame: in the perioperative period
measure: Postoperative recovery of intestinal peristalsis
timeFrame: in the perioperative period
measure: cases converted to open surgery
timeFrame: in the perioperative period
measure: The mean postoperative hospital stay
timeFrame: in the perioperative period
Other outcomes:
Locations:
city: Ch'ang-ch'un
country: China
facility: the First Hospital of Jilin University
state: Ji Lin
Study officials:
References: