Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT05181306
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2021-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Oncologic Outcomes of Robotic Versus Laparoscopic Total Gastrectomy for Advanced Gastric Cancer
Sponsor:
Southwest Hospital, China
Organization:
Study Overview
Official Title:
Long-term Oncologic Outcomes of Robotic Versus Laparoscopic Total Gastrectomy for Advanced Gastric Cancer: A Propensity Score Matching Study
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a retrospective, single-center, controlled and observation trial comparing robotic total gastrectomy with D2 lymph nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.
Detailed Description:
Since Kitano firstly reported laparoscopy-assisted distal gastrectomy in 1994, the number of patients undergoing the laparoscopic procedure has gradually increased. The latest Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an optional treatment for cStage（clinical stage） Ⅰ gastric cancer (GC).
Based on the experience of early GC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC) especially in east world like China, Japan and Korea. Though applying laparoscopic total gastrectomy (LTG) is much more difficulty than that of distal gastrectomy (DG), there are a mount of centers reported their experiences of this procedure. A meta-analysis including seventeen studies of 2313 patients (955 in LTG and 1358 in open total gastrectomy) demonstrated that LTG can have less blood loss, fewer analgesic uses, earlier passage of flatus, quicker resumption of oral intake, earlier hospital discharge, and reduced postoperative morbidity. However, the number of harvested lymph nodes, proximal resection margin, hospital mortality, 5-year OS(overall survival) and DFS(disease-free survival) were similar in both groups. According to the existing reports, LTG is technically safety and feasibility.
To overcome the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages since Hashizume firstly reported. Yoon and Son respectively compared robot total gastrectomy (RTG) with LTG, they drew a common conclusion that the number of dissected lymph nodes and postoperative complications were similar in both groups. But Son found that the mean numbers of retrieved lymph nodes along the splenic artery from RTG was higher than LTG (2.3 vs. 1.0, p = 0.013), as was also the case at the splenic hilum and artery (3.6 vs.1.9, p = 0.014). Regretfully, most of their reported cases were early gastric cancer (EGC). Other literatures reported AGC patients under RTG or LTG together with distal gastrectomy (DG), the investigators haven't found any literature compare RTG with LTG alone for AGC retrospectively.
Since most literatures are EGC patients and retrospectively researches, the investigators can't insist that patients with AGC may benefit under RTG. Therefore, the investigators launch this retrospective, single-center, controlled observation trial comparing RTG for locally advanced gastric cancer patients with LTG. In the process of research, it will be divided into two groups according to the willing of patients or their legal representatives who choose one of the two procedures(RTG or LTG) to cure GC.
Based on the experience of early GC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC) especially in east world like China, Japan and Korea. Though applying laparoscopic total gastrectomy (LTG) is much more difficulty than that of distal gastrectomy (DG), there are a mount of centers reported their experiences of this procedure. A meta-analysis including seventeen studies of 2313 patients (955 in LTG and 1358 in open total gastrectomy) demonstrated that LTG can have less blood loss, fewer analgesic uses, earlier passage of flatus, quicker resumption of oral intake, earlier hospital discharge, and reduced postoperative morbidity. However, the number of harvested lymph nodes, proximal resection margin, hospital mortality, 5-year OS(overall survival) and DFS(disease-free survival) were similar in both groups. According to the existing reports, LTG is technically safety and feasibility.
To overcome the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages since Hashizume firstly reported. Yoon and Son respectively compared robot total gastrectomy (RTG) with LTG, they drew a common conclusion that the number of dissected lymph nodes and postoperative complications were similar in both groups. But Son found that the mean numbers of retrieved lymph nodes along the splenic artery from RTG was higher than LTG (2.3 vs. 1.0, p = 0.013), as was also the case at the splenic hilum and artery (3.6 vs.1.9, p = 0.014). Regretfully, most of their reported cases were early gastric cancer (EGC). Other literatures reported AGC patients under RTG or LTG together with distal gastrectomy (DG), the investigators haven't found any literature compare RTG with LTG alone for AGC retrospectively.
Since most literatures are EGC patients and retrospectively researches, the investigators can't insist that patients with AGC may benefit under RTG. Therefore, the investigators launch this retrospective, single-center, controlled observation trial comparing RTG for locally advanced gastric cancer patients with LTG. In the process of research, it will be divided into two groups according to the willing of patients or their legal representatives who choose one of the two procedures(RTG or LTG) to cure GC.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: