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

Young Joon Lee, Sang Ho Jeong, Hoon Hur, Sang Uk Han, Jae Seok Min, Ji Yeong An, Woo Jin Hyung, Gyu Seok Cho, Gui Ae Jeong, Oh Jeong, Young Kyu Park, Mi Ran Jung, Young Woo Kim, Hong Man Yoon, Bang Wool Eom, Ji Yeon Park, Keun Won Ryu

Research output: Contribution to journalArticle

15 Citations (Scopus)

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.

Original languageEnglish
Article numbere1894
JournalMedicine (United States)
Volume94
Issue number43
DOIs
Publication statusPublished - 2015 Jan 1

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Feasibility Studies
Quality Control
Multicenter Studies
Stomach Neoplasms
Dissection
Gastrectomy
Staining and Labeling
Checklist
cyhalothrin
Lymph Nodes
Hematoxylin
Eosine Yellowish-(YS)
Neoplasm Metastasis
Biopsy

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Lee, Young Joon ; Jeong, Sang Ho ; Hur, Hoon ; Han, Sang Uk ; Min, Jae Seok ; An, Ji Yeong ; Hyung, Woo Jin ; Cho, Gyu Seok ; Jeong, Gui Ae ; Jeong, Oh ; Park, Young Kyu ; Jung, Mi Ran ; Kim, Young Woo ; Yoon, Hong Man ; Eom, Bang Wool ; Park, Ji Yeon ; Ryu, Keun Won. / 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. In: Medicine (United States). 2015 ; Vol. 94, No. 43.
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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.",
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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. / Lee, Young Joon; Jeong, Sang Ho; Hur, Hoon; Han, Sang Uk; Min, Jae Seok; An, Ji Yeong; Hyung, Woo Jin; Cho, Gyu Seok; Jeong, Gui Ae; Jeong, Oh; Park, Young Kyu; Jung, Mi Ran; Kim, Young Woo; Yoon, Hong Man; Eom, Bang Wool; Park, Ji Yeon; Ryu, Keun Won.

In: Medicine (United States), Vol. 94, No. 43, e1894, 01.01.2015.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Prospective multicenter feasibility study of laparoscopic sentinel basin dissection for organ preserving surgery in gastric cancer

T2 - Quality control study for surgical standardization prior to phase III trial

AU - Lee, Young Joon

AU - Jeong, Sang Ho

AU - Hur, Hoon

AU - Han, Sang Uk

AU - Min, Jae Seok

AU - An, Ji Yeong

AU - Hyung, Woo Jin

AU - Cho, Gyu Seok

AU - Jeong, Gui Ae

AU - Jeong, Oh

AU - Park, Young Kyu

AU - Jung, Mi Ran

AU - Kim, Young Woo

AU - Yoon, Hong Man

AU - Eom, Bang Wool

AU - Park, Ji Yeon

AU - Ryu, Keun Won

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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.

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