Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893]

Abstract

BackgroundExtended systemic lymphadenectomy (D2) is standard procedure for surgical treatment of advanced gastric cancer (AGC) although less extensive lymphadenectomy (D1) can be applied to early gastric cancer. Complete D2 lymphadenectomy is the mandatory procedure for studies that evaluate surgical treatment results of AGC. However, the actual extent of D2 lymphadenectomy varies among surgeons because of a lacking consensus on the anatomical definition of each lymph node station. This study is aimed to develop a consensus for D2 lymphadenectomy and also to qualify surgeons that can perform both laparoscopic and open D2 gastrectomy.Methods/DesignThis (KLASS-02-QC) is a prospective, observational, multicenter study to qualify the surgeons that will participate in the KLASS-02-RCT, which is a prospective, randomized, clinical trial comparing laparoscopic and open gastrectomy for AGC. Surgeons and reviewers participating in the study will be required to complete a questionnaire detailing their professional experience and specific gastrectomy surgical background/training, and the gastrectomy metrics of their primary hospitals. All surgeons must submit three laparoscopic and three open D2 gastrectomy videos, respectively. Each video will be allocated to five peer reviewers; thus each surgeon’s operations will be assessed by a total of 30 reviews. Based on blinded assessment of unedited videos by experts’ review, a separate review evaluation committee will decide whether or not the evaluated surgeon will participate in the KLASS-02-RCT. The primary outcome measure is each surgeon’s proficiency, as assessed by the reviewers based on evaluation criteria for completeness of D2 lymphadenectomy.DiscussionWe believe that our study for standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC) will guarantee successful implementation of the subsequent KLASS-02-RCT study. After making consensus on D2 lymphadenectomy, we developed evaluation criteria for completeness of D2 lymphadenectomy. We also developed a unique surgical standardization and quality control system that consists of recording unedited surgical videos, and expert review according to evaluation criteria for completeness of D2 lymphadenectomy. We hope our systematic approach will set a milestone in surgical standardization that is essential for surgical clinical trials. Additionally, our methods will serve as a novel system for educating surgeons and assessing surgical proficiency.Trial registrationNCT01283893.

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.…”

Single incision gastrectomy for gastric cancer

“…For early gastric cancer, laparoscopic gastrectomy and lymph node dissection is considered safe and comparable procedure in terms of postoperative outcome even in large scale randomized clinical trial, and also expected to show promising long-term survival outcome (2)(3)(4). Technically, laparoscopic gastrectomy may be feasible and gradually standardized even for advanced gastric cancer (5).…”

Presence of cancer cells in the periarterial tissues of patients with advanced gastric cancer

“…A recent paper that described the standardization of D2 lymphadenectomy and surgical quality control used the term 'exposure of vessels' to describe suprapancreatic lymphadenectomy (15). However, previous reports have not distinguished between the preservation and removal of periarterial tissues.…”