Status:
COMPLETED
Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
Lead Sponsor:
Fujian Medical University
Conditions:
Stomach Neoplasm
Robotic Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.
Detailed Description
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The stu...
Eligibility Criteria
Inclusion
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- expected to perform distal gastrectomy with D1+/D2 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
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- 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
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03313700
Start Date
September 25 2017
End Date
January 13 2023
Last Update
June 22 2023
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000