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

Adenocarcinoma of the Esophagogastric Junction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647540
• Other study ID #: 130020
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2020
• Source: Jilin University
• Contact: Dong Yang, Master
• Email: 714488468[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: August 30, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagogastric Junction
• Esophageal Neoplasms
• Fluorescence Laparoscopy

Intervention

Procedure:
• fluorescent laparoscopic radical gastrectomy
The gastrectomy for group F would be underwent by the fluorescence laparoscopy. All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.
• traditional laparoscopic radical gastrectomy
The gastrectomy for group L would be underwent by the laparoscopy.All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Ch'ang-ch'un	Ji Lin

Sponsors (1)

Lead Sponsor	Collaborator
Dong Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of the dissected lymph nodes	It includes the total number of the dissected lymph nodes and every group of lymph nodes	in the perioperative period
Secondary	3-year disease-free survival		three years after operation]
Secondary	the incidence of complications		one month after surgery
Secondary	the operation time	The descriptive name of unit would be minute (min).	in the perioperative period
Secondary	the blood loss during the operation	The descriptive name of unit would be millilitre (ml).	in the perioperative period
Secondary	Postoperative recovery of intestinal peristalsis	The descriptive name of unit would be hour (h).	in the perioperative period
Secondary	cases converted to open surgery		in the perioperative period
Secondary	The mean postoperative hospital stay	The descriptive name of unit would be day (d).	in the perioperative period