Clinical trial NCT04351321: The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.
Official title: A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 laparoscopic total gastrectomy.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 years；
2. 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.；
3. Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
4. 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)；
5. BMI(Body Mass Index)\<30 kg/m2；
6. No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
8. Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
9. Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
10. Sufficient vital organ functions；
11. Signed informed consent.

Exclusion Criteria:

1. Preoperative examination indicates disease stage cStage II or above；
2. Women during pregnancy or lactation；
3. Suffer from other malignant tumors within 5 years；
4. Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
5. Severe mental illness；
6. Severe respiratory disease；
7. Severe liver and kidney dysfunction；
8. History of unstable angina or myocardial infarction within 6 months；
9. History of cerebral infarction or cerebral hemorrhage within 6 months；
10. Continuous application of glucocorticoid within 1 month (except for topical application)；
11. Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
12. The patient has participated in or is participating in other clinical studies (within 6 months).

Primary outcomes:
measure: The incidence of postoperative morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Quality of life score
timeFrame: 3, 6 and 12 months
measure: Quality of life score
timeFrame: 3, 6 and 12 months
measure: Overall incidence of postoperative morbidity
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: