NCT02327481CompletedNot Applicable
Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
Fujian Medical University0 sites438 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 438
- Primary Endpoint
- Operating time
Study Overview
Brief Summary
The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.
Detailed Description
A prospective randomized comparison of 3D and 2D 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 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1)Age from over 19 to under 74 years
- •(2)cT1-4a(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 the main abdominal 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 the past six months
- •(6)History of cerebrovascular accident within the 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
Outcomes
Primary Outcomes
Operating time
Time Frame: 1 day
Operating time
Secondary Outcomes
- Intraoperative situation(1 day)
- Postoperative recovery course(10 days)
- The postoperative pathology(7 days)
- Inflammatory and immune response(7 days)
- 5-year overall survival rate(60 months)
- 3-year disease free survival rate(36 months)
- Recurrence patterns(60 months)
- Complication(30 days;36 months)
- Morbidity and mortality(30 days;36 months)
- 3-year overall survival rate(36 months)
- 5-year disease free survival rate(60 months)
- Hospitalization expenses(1 months)
Investigators
Chang-Ming Huang, Prof.
Fujian Medical University Union Hospital
Fujian Medical University
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