A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG
NCT ID: NCT04423354
Last Updated: 2020-06-09
Study Results
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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UNKNOWN
NA
94 participants
INTERVENTIONAL
2019-03-25
2024-03-31
Brief Summary
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Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.
Primary study endpoints: The incidences of early postoperative complications and mortality.
The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.
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Detailed Description
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2. Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Research group
Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy.
Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.
Interventions
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Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.
Eligibility Criteria
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Inclusion Criteria
* The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
* The endoscopic biopsy was diagnosed with adenocarcinoma;
* Preoperative clinical staging was cT1-4aNanyM0
* No distant metastasis and invasion of surrounding organs were found;
* ECOG score ranged from 0 to 1;
* ASA score ranged from I to III.
Exclusion Criteria
* Have a severe mental illness
* History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
* History of other malignant tumors within 5 years
* History of unstable angina pectoris or myocardial infarction within 6 months
* FEV1% of pulmonary function test was less than 50% of expected value
* History of cerebral infarction or cerebral hemorrhage within 6 months
* Have severe liver and kidney damage
18 Years
78 Years
ALL
No
Sponsors
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Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Wei Wang
Chief physician
Principal Investigators
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wei wang, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Guangdong PHTCM
Locations
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Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WWang
Identifier Type: -
Identifier Source: org_study_id
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