The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.
NCT ID: NCT04351321
Last Updated: 2020-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
560 participants
INTERVENTIONAL
2020-07-31
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Totally Laparoscopic Total Gastrectomy
Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group.
Totally Laparoscopic Total Gastrectomy
Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
Laparoscopy-Assisted Total Gastrectomy
Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group.
Laparoscopy-Assisted Total Gastrectomy
Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
Interventions
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Totally Laparoscopic Total Gastrectomy
Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
Laparoscopy-Assisted Total Gastrectomy
Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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CLASS08
Identifier Type: -
Identifier Source: org_study_id
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