Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
NCT ID: NCT03313700
Last Updated: 2023-06-22
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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COMPLETED
NA
300 participants
INTERVENTIONAL
2017-09-25
2023-01-13
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
NONE
Study Groups
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Robotic Distal Gastrectomy
Robotic Distal Gastrectomy will be performed for the treatment of patients assigned to this group.
Robotic Distal Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.
Laparoscopic Distal Gastrectomy
Laparoscopic Distal Gastrectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic Distal Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.
Interventions
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Robotic Distal Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.
Laparoscopic Distal Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.
Eligibility Criteria
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Inclusion Criteria
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal gastrectomy with D1+/D2 lymph node dissction to obtain R0 resection sugicall results.
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent
Exclusion Criteria
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
5. Gastric multiple primary carcinoma
6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
7. History of other malignant disease within the past 5 years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within the past 6 months
10. History of cerebrovascular accident within the past 6 months
11. History of continuous systematic administration of corticosteroids within 1 month
12. Requirement of simultaneous surgery for other disease
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
14. FEV1\<50% of the predicted values
18 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Director, Head of gastric surgery, Principal Investigator, Clinical Professor
Principal Investigators
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Changming Huang, Professor
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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References
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Lu J, Wu D, Huang JB, Lin J, Xu BB, Xue Z, Zheng HL, Lin GS, Shen LL, Li P, Wang JB, Lin JX, Chen QY, Cao LL, Xie JW, Zheng CH, Huang CM. Comparison of robotic versus laparoscopic versus open distal gastrectomy for locally advanced gastric cancer: a prospective trial-based economic evaluation. Surg Endosc. 2023 Oct;37(10):7472-7485. doi: 10.1007/s00464-023-10147-1. Epub 2023 Jul 3.
Other Identifiers
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2017-02
Identifier Type: -
Identifier Source: org_study_id
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