Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT03273920
Status:
UNKNOWN
Last Update Posted:
2017-09-08
First Post:
2017-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Sponsor:
Southwest Hospital, China
Organization:
Study Overview
Official Title:
Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
NOT_YET_RECRUITING
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 an investigator-initiated, randomized, controlled, parallel group, and non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.
Detailed Description:
Since the first case of laparoscopy-assisted distal gastrectomy was reported 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 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). According to the results of large-scaled retrospective studies and ongoing randomized controlled trials (RCTs), LG treating AGC can gain better short-term outcomes and comparable long-term oncologic results.
To minimize the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages. Though the feasibility and safety of robotic gastrectomy (RG) have been well accepted, the benefits of RG remain controversial. A recent meta-analysis including eleven studies of 3503 patients demonstrated that RG indicated potentially favorable outcomes in terms of blood loss compared with LG. Furthermore, it has been confirmed that robotic system could provide an advantage over LG in the dissection of the N2 area lymph nodes, especially around the splenic artery area. Our previous study demonstrated that the RG had less intraoperative blood loss and more lymph nodes dissection compared with the laparoscopic procedure. However, the only prospective study reported that RG is not superior to LG in terms of perioperative surgical outcomes. Nevertheless, the following subgroup analysis found that patients with GC undergoing D2 lymph node dissection can benefit from less blood loss when a robotic surgery system is used. Take together, RG with D2 nodal dissection may be superior laparoscopic surgery in terms of blood loss and retrieved lymph nodes. However, lack of high-level evidence-based medical researches, we can't drew a conclusion that patients with AGC may benefit from RG with D2 nodal dissection.
With regard to a new surgical approach, oncologic safety has attracted more attention. Although some retrospective studies have demonstrated that RG with lymphadenectomy for GC had non-inferior oncologic outcome relative to LG, there is no prospective RCT to evaluate the long-term outcomes of RG. Therefore, the Chinese Robotic Gastrointestinal Surgery Study (CRASS) Group launched a multicenter prospective RCT to verify the short-term and long-term outcomes of RG in AGC. The primary objective of this study is to assess whether robot-assisted distal gastrectomy is comparable to laparoscopic approach in terms of long-term oncologic outcomes without compromising relapse-free survival. The secondary research objectives are to compare robotic and laparoscopic approach in terms of morbidity, mortality, quality of life, cost-effectiveness, and overall survival.
To minimize the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages. Though the feasibility and safety of robotic gastrectomy (RG) have been well accepted, the benefits of RG remain controversial. A recent meta-analysis including eleven studies of 3503 patients demonstrated that RG indicated potentially favorable outcomes in terms of blood loss compared with LG. Furthermore, it has been confirmed that robotic system could provide an advantage over LG in the dissection of the N2 area lymph nodes, especially around the splenic artery area. Our previous study demonstrated that the RG had less intraoperative blood loss and more lymph nodes dissection compared with the laparoscopic procedure. However, the only prospective study reported that RG is not superior to LG in terms of perioperative surgical outcomes. Nevertheless, the following subgroup analysis found that patients with GC undergoing D2 lymph node dissection can benefit from less blood loss when a robotic surgery system is used. Take together, RG with D2 nodal dissection may be superior laparoscopic surgery in terms of blood loss and retrieved lymph nodes. However, lack of high-level evidence-based medical researches, we can't drew a conclusion that patients with AGC may benefit from RG with D2 nodal dissection.
With regard to a new surgical approach, oncologic safety has attracted more attention. Although some retrospective studies have demonstrated that RG with lymphadenectomy for GC had non-inferior oncologic outcome relative to LG, there is no prospective RCT to evaluate the long-term outcomes of RG. Therefore, the Chinese Robotic Gastrointestinal Surgery Study (CRASS) Group launched a multicenter prospective RCT to verify the short-term and long-term outcomes of RG in AGC. The primary objective of this study is to assess whether robot-assisted distal gastrectomy is comparable to laparoscopic approach in terms of long-term oncologic outcomes without compromising relapse-free survival. The secondary research objectives are to compare robotic and laparoscopic approach in terms of morbidity, mortality, quality of life, cost-effectiveness, and overall survival.
Study Oversight
Has Oversight DMC:
True
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?: