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

NCT ID: NCT03647540

Last Updated: 2020-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2022-08-30

Brief Summary

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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

Detailed Description

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Conditions

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Fluorescence Laparoscopy Adenocarcinoma of the Esophagogastric Junction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group F

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 Type EXPERIMENTAL

fluorescent laparoscopic radical gastrectomy

Intervention Type 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 L

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

Group Type ACTIVE_COMPARATOR

traditional laparoscopic radical gastrectomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong Yang

OTHER

Sponsor Role lead

Responsible Party

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Dong Yang

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Yang, Master

Role: CONTACT

Quan Wang, Doctor

Role: CONTACT

043181875602

Facility Contacts

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Quan Wang, Professor

Role: primary

Other Identifiers

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130020

Identifier Type: -

Identifier Source: org_study_id

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