Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
NCT ID: NCT03524300
Last Updated: 2020-02-05
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
220 participants
INTERVENTIONAL
2018-06-01
2024-11-30
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 Assisted Total Gastrectomy
Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
Robotic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
Laparoscopic Assisted Total Gastrectomy
Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.
Interventions
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Robotic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
Laparoscopic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.
Eligibility Criteria
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Inclusion Criteria
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
* The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) class I to III
* Written informed consent
Exclusion Criteria
* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* Multiple primary cancer
* History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
* Gastric multiple primary carcinoma
* Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
* History of other malignant disease within the past 5 years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within the past 6 months
* History of cerebrovascular accident within the past 6 months
* History of continuous systematic administration of corticosteroids within 1 month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* 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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Central Contacts
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Facility Contacts
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Other Identifiers
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FUGES-015
Identifier Type: -
Identifier Source: org_study_id
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