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

Primary Purpose

Fluorescence Laparoscopy, Adenocarcinoma of the Esophagogastric Junction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fluorescent laparoscopic radical gastrectomy
traditional laparoscopic radical gastrectomy
Sponsored by
Dong Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluorescence Laparoscopy focused on measuring fluorescence laparoscopy, adenocarcinoma of the esophagogastric junction (AEG)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • the First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group F

Group L

Arm Description

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

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

Outcomes

Primary Outcome Measures

the number of the dissected lymph nodes
It includes the total number of the dissected lymph nodes and every group of lymph nodes

Secondary Outcome Measures

3-year disease-free survival
the incidence of complications
the operation time
The descriptive name of unit would be minute (min).
the blood loss during the operation
The descriptive name of unit would be millilitre (ml).
Postoperative recovery of intestinal peristalsis
The descriptive name of unit would be hour (h).
cases converted to open surgery
The mean postoperative hospital stay
The descriptive name of unit would be day (d).

Full Information

First Posted
August 23, 2018
Last Updated
April 15, 2020
Sponsor
Dong Yang
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1. Study Identification

Unique Protocol Identification Number
NCT03647540
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dong Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluorescence Laparoscopy, Adenocarcinoma of the Esophagogastric Junction
Keywords
fluorescence laparoscopy, adenocarcinoma of the esophagogastric junction (AEG)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group F
Arm Type
Experimental
Arm Description
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
Arm Title
Group L
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
fluorescent laparoscopic radical gastrectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
traditional laparoscopic radical gastrectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
the number of the dissected lymph nodes
Description
It includes the total number of the dissected lymph nodes and every group of lymph nodes
Time Frame
in the perioperative period
Secondary Outcome Measure Information:
Title
3-year disease-free survival
Time Frame
three years after operation]
Title
the incidence of complications
Time Frame
one month after surgery
Title
the operation time
Description
The descriptive name of unit would be minute (min).
Time Frame
in the perioperative period
Title
the blood loss during the operation
Description
The descriptive name of unit would be millilitre (ml).
Time Frame
in the perioperative period
Title
Postoperative recovery of intestinal peristalsis
Description
The descriptive name of unit would be hour (h).
Time Frame
in the perioperative period
Title
cases converted to open surgery
Time Frame
in the perioperative period
Title
The mean postoperative hospital stay
Description
The descriptive name of unit would be day (d).
Time Frame
in the perioperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Yang, Master
Email
714488468@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Wang, Doctor
Phone
043181875602
Email
wangquanjdyy@163.com
Facility Information:
Facility Name
the First Hospital of Jilin University
City
Ch'ang-ch'un
State/Province
Ji Lin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Wang, Professor
Email
18844097668@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

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

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