Gastric Cancer Clinical Trial
Official title:
Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial
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.
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.
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