NCT04010006
Unknown
Not Applicable
Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)
Fujian Medical University1 site in 1 country502 target enrollmentJuly 15, 2019
ConditionsStomach Neoplasms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stomach Neoplasms
- Sponsor
- Fujian Medical University
- Enrollment
- 502
- Locations
- 1
- Primary Endpoint
- operating time
- Last Updated
- 6 years ago
Overview
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 extensive application of the 4K laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
Investigators
Chang-Ming Huang, Prof.
Director, Head of gastric surgery, Principal Investigator, Clinical Professor
Fujian Medical University
Eligibility Criteria
Inclusion Criteria
- •(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 Criteria
- •(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
Outcomes
Primary Outcomes
operating time
Time Frame: 1 day
day
Secondary Outcomes
- Time to first soft diet(10 days)
- intracavitary anastomosis time(1 day)
- the number of positive lymph nodes(1 day)
- intraoperative lymph node dissection time(1 day)
- intraoperative blood loss(1 day)
- the amount of use of titanium clip(1 day)
- duration of postoperative hospital stay(10 days)
- 3-year overall survival rate(36 months)
- Time to first ambulation(10 days)
- Time to first flatus(10 days)
- Complication(30 days;36 months)
- The number of lymph node dissection(1 day)
- intraoperative injury(1 day)
- Hospitalization expenses(1 months)
- Time to first liquid diet(10 days)
- the rate of conversion to laparotomy(1 day)
- The daily highest body temperature before discharge(7 days)
- Overall postoperative morbidity and mortality rates(30 days)
- 3-year disease free survival rate(36 months)
Study Sites (1)
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