Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
NCT ID: NCT04010006
Last Updated: 2020-01-07
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
502 participants
INTERVENTIONAL
2019-07-15
2023-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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4K Laparoscopic Surgery
4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
4K Laparoscopic Surgery
4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
HD Laparoscopic Surgery
HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
HD Laparoscopic Surgery
HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Interventions
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4K Laparoscopic Surgery
4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
HD Laparoscopic Surgery
HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Eligibility Criteria
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Inclusion Criteria
* (2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* (3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications
* (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
* (5)American Society of Anesthesiology (ASA) score class I, II, or III
* (6)Written informed consent
Exclusion Criteria
* (2)Severe mental disorder
* (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
* (5)History of unstable angina or myocardial infarction within past six months
* (6)History of cerebrovascular accident within past six months
* (7)History of continuous systematic administration of corticosteroids within one month
* (8)History of previous neoadjuvant chemotherapy or radiotherapy
* (9)T4b tumors
* (10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* (11)FEV1(Forced expiratory volume in one second)#50% of predicted values
19 Years
74 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Director, Head of gastric surgery, Principal Investigator, Clinical Professor
Principal Investigators
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Changming Huang Huang
Role: STUDY_CHAIR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Other Identifiers
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FUGES-017
Identifier Type: -
Identifier Source: org_study_id
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