Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
NCT ID: NCT04795063
Last Updated: 2021-03-12
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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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2021-03-01
2027-01-01
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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Total Robotic Distal Gastrectomy
After exploration and randomization, patients received total robotic distal gastrectomy
Total Robotic Distal Gastrectomy
All the surgical procedures are performed using the robot system.
Robotic-Assisted Distal Gastrectomy
After exploration and randomization, patients received robotic-assisted distal gastrectomy.
Robotic-Assisted Distal Gastrectomy
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
Interventions
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Total Robotic Distal Gastrectomy
All the surgical procedures are performed using the robot system.
Robotic-Assisted Distal Gastrectomy
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
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 dissection to obtain R0 resection surgicall results.
5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
6. American Society of Anesthesiology (ASA) 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 Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) 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. Forced expiratory volume in 1 second (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.
Professor
Principal Investigators
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Chang-ming Huang, MD
Role: STUDY_CHAIR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FUGES-022
Identifier Type: -
Identifier Source: org_study_id
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