Status:
UNKNOWN
The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopi...
Eligibility Criteria
Inclusion
- Aged 18-75 years；
- Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
- Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
- The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
- BMI(Body Mass Index)\<30 kg/m2；
- No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
- No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
- Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
- Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
- Sufficient vital organ functions；
- Signed informed consent.
Exclusion
- Preoperative examination indicates disease stage cStage II or above；
- Women during pregnancy or lactation；
- Suffer from other malignant tumors within 5 years；
- Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
- Severe mental illness；
- Severe respiratory disease；
- Severe liver and kidney dysfunction；
- History of unstable angina or myocardial infarction within 6 months；
- History of cerebral infarction or cerebral hemorrhage within 6 months；
- Continuous application of glucocorticoid within 1 month (except for topical application)；
- Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
- The patient has participated in or is participating in other clinical studies (within 6 months).
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT04351321
Start Date
July 1 2020
End Date
August 1 2023
Last Update
April 17 2020
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