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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
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 pha...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985421/ https://www.ncbi.nlm.nih.gov/pubmed/26512607 http://dx.doi.org/10.1097/MD.0000000000001894 |
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author | 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 |
author_facet | 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 |
author_sort | Lee, Young Joon |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4985421 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-49854212016-08-26 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 Medicine (Baltimore) 7100 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. Wolters Kluwer Health 2015-10-30 /pmc/articles/PMC4985421/ /pubmed/26512607 http://dx.doi.org/10.1097/MD.0000000000001894 Text en Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an open access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0, where it is permissible to download, share and reproduce the work in any medium, provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0 |
spellingShingle | 7100 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | 7100 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985421/ https://www.ncbi.nlm.nih.gov/pubmed/26512607 http://dx.doi.org/10.1097/MD.0000000000001894 |
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