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

NCT03647540 | Unknown

• 1 other identifier: 130020
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Conditions

Fluorescence Laparoscopy; Adenocarcinoma of the Esophagogastric Junction

Keywords

fluorescence laparoscopy; adenocarcinoma of the esophagogastric junction (AEG)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 3-year disease-free survival

  three years after operation]

• the incidence of complications

  one month after surgery

• the operation time

  in the perioperative period

• the blood loss during the operation

  in the perioperative period

• Postoperative recovery of intestinal peristalsis

  in the perioperative period

Study Arms (2)

Group F

EXPERIMENTAL

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

Procedure: fluorescent laparoscopic radical gastrectomy

Group L

ACTIVE COMPARATOR

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

Procedure: traditional laparoscopic radical gastrectomy

Interventions

fluorescent laparoscopic radical gastrectomy PROCEDURE

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.

Group F

traditional laparoscopic radical gastrectomy PROCEDURE

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.

Group L

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Dong Yang: lead

Study Sites (1)

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, 130021, China

RECRUITING

Central Study Contacts

Dong Yang, Master

CONTACT

714488468@qq.com

Quan Wang, Doctor

CONTACT

043181875602; wangquanjdyy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: August 30, 2018
• Primary Completion: June 30, 2020
• Study Completion: August 30, 2022
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)