Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      This study is a prospective, single-center, non-randomized, controlled, non-blind, and
      non-inferiority observation trial comparing robotic-assisted 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 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-assisted total gastrectomy (LATG)
      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 LATG and 1358 in open total gastrectomy) demonstrated that LATG 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 and
      DFS were similar in both groups. According to the existing reports, LATG 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-assisted total gastrectomy (RATG) with LATG, 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 LNs along the
      splenic artery from RATG was higher than LATG (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 RATG or
      LATG together with distal gastrectomy (DG), we haven't found any literature compare RATG with
      LATG alone for AGC retrospectively.

      Since most literatures are EGC patients and retrospectively researches, we can't insist that
      patients with AGC may benefit under RATG. Therefore, we launch this prospective,
      single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial
      comparing RATG for locally advanced gastric cancer patients with LATG.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(RATG or LATG) to cure GC.The
      primary objective of this study is to assess whether RATG is comparable to laparoscopic
      approach in terms of overall postoperative morbidity rates. The secondary research objectives
      are to compare robotic with laparoscopic approach in terms of surgical outcomes,
      postoperative recovery courses.
    

Intervention name(s): Robotic-assisted Total Gastrectomy; Laparoscopic-assisted Total Gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Robotic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose robotic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.; Laparoscopic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose laparoscopic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with gastric cancer who need to received total gastrectomy with D2
        lymphadenectomy.
      
Keywords: Laparoscopic; Robotic; Total Gastrectomy; AGC