Status:
UNKNOWN
Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
Lead Sponsor:
Fujian Medical University
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
19-74 years
Phase:
NA
Brief Summary
The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.
Detailed Description
A prospective randomized comparison of HD and 4K laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the...
Eligibility Criteria
Inclusion
- (1)Age from over 19 to under 74 years
- (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
- (1)Women during pregnancy or breast-feeding
- (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
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2023
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT04010006
Start Date
July 15 2019
End Date
July 15 2023
Last Update
January 7 2020
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000