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

Abstract

BACKGROUND: Extended 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/DESIGN: This (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. DISCUSSION: We

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

REGISTRATION: NCT01283893.