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

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ClinicalTrials.gov Identifier: NCT03647540
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Wang Quan
Information provided by (Responsible Party):
Dong Yang, Jilin University

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

Condition or disease Intervention/treatment Phase
Fluorescence Laparoscopy Adenocarcinoma of the Esophagogastric Junction Procedure: fluorescent laparoscopic radical gastrectomy Procedure: traditional laparoscopic radical gastrectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction
Estimated Study Start Date : August 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.

Active Comparator: 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
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.




Primary Outcome Measures :
  1. the number of the dissected lymph nodes [ Time Frame: in the perioperative period ]
    It includes the total number of the dissected lymph nodes and every group of lymph nodes


Secondary Outcome Measures :
  1. 3-year disease-free survival [ Time Frame: three years after operation] ]
  2. the incidence of complications [ Time Frame: one month after surgery ]
  3. the operation time [ Time Frame: in the perioperative period ]
    The descriptive name of unit would be minute (min).

  4. the blood loss during the operation [ Time Frame: in the perioperative period ]
    The descriptive name of unit would be millilitre (ml).

  5. Postoperative recovery of intestinal peristalsis [ Time Frame: in the perioperative period ]
    The descriptive name of unit would be hour (h).

  6. cases converted to open surgery [ Time Frame: in the perioperative period ]
  7. The mean postoperative hospital stay [ Time Frame: in the perioperative period ]
    The descriptive name of unit would be day (d).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647540


Contacts
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Contact: Dong Yang, Master 714488468@qq.com
Contact: Quan Wang, Doctor 043181875602 wangquanjdyy@163.com

Locations
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China, JI Lin
the First Hospital of Jilin University
Ch'ang-ch'un, JI Lin, China, 130021
Sponsors and Collaborators
Dong Yang
Wang Quan

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Responsible Party: Dong Yang, Doctor, Jilin University
ClinicalTrials.gov Identifier: NCT03647540     History of Changes
Other Study ID Numbers: 130020
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

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

Keywords provided by Dong Yang, Jilin University:
fluorescence laparoscopy
adenocarcinoma of the esophagogastric junction (AEG)

Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases