Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001)

Abstract

PurposeLaparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer.Materials and MethodsPatients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopy-assisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation.DiscussionOncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer.Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).

Evaluation of laparoscopic total gastrectomy for advanced gastric cancer: results of a comparison with laparoscopic distal gastrectomy

“…Among the less invasive operations noted in recent years, laparoscopic gastrectomy for gastric cancer has become popular due to advances in surgical techniques. As experience with LG for early gastric cancer has accumulated, some centers have attempted to expand the indication of LG to AGC, and a few studies have already demonstrated that surgeons can safely perform laparoscopic gastrectomy in these cases and that the patients had less postoperative pain, faster recoveries, shorter hospital stays, and better qualities of life than those who underwent conventional open surgery [20,21]. Unfortunately, the majority of studies conducted on laparoscopic gastrectomy have been confined to the outcomes of LDG, and thus, LTG has not been adequately addressed.…”

Comparison of laparoscopic versus open gastrectomy for advanced gastric cancer: an updated meta-analysis

“…Among the remaining articles, 19 studies [37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55] were excluded because EGC cases were mixed with AGCs in the cohort studies and data on AGCs were not extractable. Eight studies were further deleted for the following reasons: 2 studies were ongoing randomized controlled trials (RCTs) that only described study design and patient enrollment criteria without results reported [56,57]; 2 studies had overlapped enrollments with former research [58,59]; 1 study reported incomplete data that were not suitable for analysis [60]; and 3 studies discussed other issues irrelevant to the topic of this meta-analysis [61][62][63]. Finally, a total of 26 studies that compared the short-term and/or long-term results of AGCs treated by LG with those of OG were included .…”

“…Laparoscopic gastrectomy has long been used to treat EGC, and in the past decade, attention has been paid to the feasibility and safety of LG for AGC. Although several clinical trials have been initiated to evaluate the effectiveness of LG [9,10,56,57], currently we do not have enough evidence to support this surgical procedure in AGC management. To this end, we conducted this meta-analysis trying to find some clues.…”

Laparoscopic gastrectomy for gastric cancer: Current evidences

“…Therefore, the non-compliance rate of clearing the defined N2 area was selected by the authors as the most important factor for the technical feasibility of the laparoscopic procedureapproach. This study is underway and the first results will offer promising and exciting evidence of the oncologic feasibility and safety of laparoscopic-assisted distal gastrectomy for patients with advanced gastric cancer, which is the main matter of debate today in Eastern patients [34].…”

“…As for advanced gastric cancer, a prospective randomized controlled multicenter trial in order to evaluate the safety and feasibility of laparoscopic-assisted D2 gastrectomy for advanced gastric cancer was conducted by Nam BH. et al and was published recently [34]. This study enrolled patients with distal gastrectomy for advanced gastric cancer staged by endoscopy and computed tomography.…”