Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
NCT Number: NCT05235932
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 opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Fuzhou, Fujian, 350001, China
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
3.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.
5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
Exclusion criteria
Most surgical procedures are performed using the robot system.
Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
Time frame: 36 months
3-year disease free survival rate
Time frame: 30 days
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time frame: 1 day
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 30 days
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Time frame: 1 day
Total Number of Retrieved Lymph Nodes
Time frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 3, 6, 9 and 12 months
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
Contact information is provided by the study sponsor or research team.
Chang-ming Huang, MD
CONTACT
Hua-long Zheng, MD
CONTACT
Fujian Medical University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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