the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
1 other identifier
interventional
570
1 country
1
Brief Summary
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable gastric-cancer
Started Feb 2022
Longer than P75 for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
February 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2027
ExpectedFebruary 11, 2022
February 1, 2022
2 years
February 10, 2022
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease free survival rate
3-year disease free survival rate
36 months
Secondary Outcomes (9)
Morbidity rates
30 days
3-year overall survival rate
36 months
3-year recurrence pattern
36 months
intraoperative morbidity rates
1 day
overall postoperative serious morbidity rates
30 days
- +4 more secondary outcomes
Study Arms (2)
Robotic radical total gastrectomy with D2 lymphadenectomy
EXPERIMENTALAfter exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy
Laparoscopic radical total gastrectomy with D2 lymphadenectomy
ACTIVE COMPARATORAfter exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy
Interventions
Most surgical procedures are performed using the robot system.
Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
Eligibility Criteria
You may qualify if:
- Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.
- Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.
- American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
You may not qualify if:
- Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy(except for ESD/EMR for gastric cancer )
- Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
- History of other malignant disease within the past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1 (forced expiratory volume in one second)\<50% of predicted values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fujian Medical Universitylead
- Chinese PLA General Hospitalcollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Lanzhou Military Region General Hospitalcollaborator
- Gansu Provincial Hospitalcollaborator
- Southwest Hospital, Chinacollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Second Xiangya Hospital of Central South Universitycollaborator
- Hebei Medical University Fourth Hospitalcollaborator
- The Affiliated Hospital of Qingdao Universitycollaborator
- The Second Affiliated Hospital of Dalian Medical Universitycollaborator
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chang-ming Huang, MD
Fujian Medical University Union Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2022
First Posted
February 11, 2022
Study Start
February 20, 2022
Primary Completion
February 20, 2024
Study Completion (Estimated)
February 20, 2027
Last Updated
February 11, 2022
Record last verified: 2022-02