title: Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection for Organ Preserving Surgery in Gastric Cancer: Quality Control Study for Surgical Standardization Prior to Phase III Trial.
abstract: The clinical application of sentinel node biopsies in early gastric cancer is still controversial even though it appears promising. This study was conducted as a prerequisite quality control for surgical standardization of laparoscopic sentinel basin dissection (SBD) prior to the initiation of a phase III trial.Laparoscopic SBD was performed in patients with preoperative stage T1-2N0 and tumor size <4 cm in diameter. Intraoperative endoscopic submucosal injection of a standardized dual tracer was administered. All retrieved sentinel basin nodes (SBN) were investigated with intraoperative frozen hematoxylin and eosin (H&E) staining. A strict checklist consisting of 7 essential steps was followed during laparoscopic SBD as the quality control study for a phase III trial. Completion of all essential steps in the checklist for 10 cases was used to define a qualified institution.Seven institutions participated and 112 patients were enrolled in this study. However, 4 patients were excluded owing to screening failure. The mean number of cases required for institutional qualification was 15 cases (range, 13-20 cases). Sentinel basins (SB) were detected and dissected in 100 of the 108 patients (92.6%); the median number of SB and SBN was 2 and 7, respectively. Lymph node metastases were detected in 10 patients by postoperative permanent H&E staining and they were detected by SBD in all 10 patients. Frozen results of SBN were compatible with permanent staining reports.Laparoscopic SBD is feasible and demonstrated improved sensitivity in detecting metastatic lymph nodes compared to the previous study. A future phase III randomized trial comparing laparoscopic SBD with organ-preserving gastrectomy and laparoscopic standard gastrectomy seems promising for qualified institutions.
authors.affiliation: From the Department of Surgery, Gyeongsang National University, Jinju (YJL, SHJ); Department of Surgery, Ajou University School of Medicine, Suwon (HH, S-UH); Department of Surgery, Dongnam Institute of Radiological and Medical Science, Busan (JSM); Department of Surgery, Yonsei University School of Medicine, Seoul (JYA, WJH); Department of Surgery, Soonchunhyang University College of Medicine, Bucheon (GSC, GAJ); Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun (OJ, YKP, MRJ); Gastric Cancer Branch, National Cancer Center, Goyang (Y-WK, HMY, BWE, KWR); and Department of Surgery, National Cancer Center, Goyang, Korea (JYP).
authors.forename: Young Joon
authors.initials: YJ
authors.lastname: Lee
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Jeong
authors.forename: Hoon
authors.initials: H
authors.lastname: Hur
authors.forename: Sang-Uk
authors.initials: SU
authors.lastname: Han
authors.forename: Jae Seok
authors.initials: JS
authors.lastname: Min
authors.forename: Ji Yeong
authors.initials: JY
authors.lastname: An
authors.forename: Woo Jin
authors.initials: WJ
authors.lastname: Hyung
authors.forename: Gyu Seok
authors.initials: GS
authors.lastname: Cho
authors.forename: Gui Ae
authors.initials: GA
authors.lastname: Jeong
authors.forename: Oh
authors.initials: O
authors.lastname: Jeong
authors.forename: Young Kyu
authors.initials: YK
authors.lastname: Park
authors.forename: Mi Ran
authors.initials: MR
authors.lastname: Jung
authors.forename: Young-Woo
authors.initials: YW
authors.lastname: Kim
authors.forename: Hong Man
authors.initials: HM
authors.lastname: Yoon
authors.forename: Bang Wool
authors.initials: BW
authors.lastname: Eom
authors.forename: Ji Yeon
authors.initials: JY
authors.lastname: Park
authors.forename: Keun Won
authors.initials: KW
authors.lastname: Ryu
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery*; D000328:Adult; D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D013505:Digestive System Surgical Procedures / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D059351:Organ Sparing Treatments / Q000379:methods*; D011446:Prospective Studies; D011786:Quality Control; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013274:Stomach Neoplasms / Q000601:surgery*