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Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study
INTRODUCTION: In the era of neoadjuvant chemotherapy in advanced gastric cancer (GC), the role of staging laparoscopy (SL) will become more established. However, despite guidelines recommendations, SL for optimal preoperative staging remains underutilized. Diagnostic value of near-infrared (NIR) / i...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10198545/ https://www.ncbi.nlm.nih.gov/pubmed/37205666 http://dx.doi.org/10.1371/journal.pone.0285758 |
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author | Rawicz-Pruszyński, Karol Sędłak, Katarzyna Pelc, Zuzanna Mlak, Radosław Litwiński, Jakub Mańko, Paweł Zinkiewicz, Krzysztof Paśnik, Iwona Cięszczyk, Katarzyna Pawlik, Timothy Märkl, Bruno Erodotou, Maria Polkowski, Wojciech P. |
author_facet | Rawicz-Pruszyński, Karol Sędłak, Katarzyna Pelc, Zuzanna Mlak, Radosław Litwiński, Jakub Mańko, Paweł Zinkiewicz, Krzysztof Paśnik, Iwona Cięszczyk, Katarzyna Pawlik, Timothy Märkl, Bruno Erodotou, Maria Polkowski, Wojciech P. |
author_sort | Rawicz-Pruszyński, Karol |
collection | PubMed |
description | INTRODUCTION: In the era of neoadjuvant chemotherapy in advanced gastric cancer (GC), the role of staging laparoscopy (SL) will become more established. However, despite guidelines recommendations, SL for optimal preoperative staging remains underutilized. Diagnostic value of near-infrared (NIR) / indocyanine green (ICG) guided sentinel node (SN) mapping in GC confirmed its technical feasibility, however no data exist regarding its potential role in pathological nodal staging. To the best of our knowledge, current study is the first to evaluate the role of ICG in nodal staging of advanced GC patients undergoing SL. MATERIALS AND METHODS: This single-arm prospective observational multicenter study was approved by the Bioethical Committee of Medical University of Lublin (Ethic Code: KE-0254/331/2018). The protocol is registered at clinicaltrial.gov (NCT05720598), and the study results will be reported according to the Strengthening of Reporting of Observational Studies in Epidemiology (STROBE) statement. The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients. The secondary endpoints include pathological and molecular assessment of retrieved SNs and other pretreatment clinical variables potentially associated with SL: pattern of perigastric ICG distribution according to patients’ pathological and clinical characteristics, neoadjuvant chemotherapy compliance, 30-day morbidity, and mortality. CONCLUSION: POLA study is the first to investigate the clinical value of ICG-enhanced sentinel node biopsy during staging laparoscopy in advanced GC patients in a Western cohort. Identifying pN status before multimodal treatment will improve GC staging process. |
format | Online Article Text |
id | pubmed-10198545 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-101985452023-05-20 Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study Rawicz-Pruszyński, Karol Sędłak, Katarzyna Pelc, Zuzanna Mlak, Radosław Litwiński, Jakub Mańko, Paweł Zinkiewicz, Krzysztof Paśnik, Iwona Cięszczyk, Katarzyna Pawlik, Timothy Märkl, Bruno Erodotou, Maria Polkowski, Wojciech P. PLoS One Study Protocol INTRODUCTION: In the era of neoadjuvant chemotherapy in advanced gastric cancer (GC), the role of staging laparoscopy (SL) will become more established. However, despite guidelines recommendations, SL for optimal preoperative staging remains underutilized. Diagnostic value of near-infrared (NIR) / indocyanine green (ICG) guided sentinel node (SN) mapping in GC confirmed its technical feasibility, however no data exist regarding its potential role in pathological nodal staging. To the best of our knowledge, current study is the first to evaluate the role of ICG in nodal staging of advanced GC patients undergoing SL. MATERIALS AND METHODS: This single-arm prospective observational multicenter study was approved by the Bioethical Committee of Medical University of Lublin (Ethic Code: KE-0254/331/2018). The protocol is registered at clinicaltrial.gov (NCT05720598), and the study results will be reported according to the Strengthening of Reporting of Observational Studies in Epidemiology (STROBE) statement. The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients. The secondary endpoints include pathological and molecular assessment of retrieved SNs and other pretreatment clinical variables potentially associated with SL: pattern of perigastric ICG distribution according to patients’ pathological and clinical characteristics, neoadjuvant chemotherapy compliance, 30-day morbidity, and mortality. CONCLUSION: POLA study is the first to investigate the clinical value of ICG-enhanced sentinel node biopsy during staging laparoscopy in advanced GC patients in a Western cohort. Identifying pN status before multimodal treatment will improve GC staging process. Public Library of Science 2023-05-19 /pmc/articles/PMC10198545/ /pubmed/37205666 http://dx.doi.org/10.1371/journal.pone.0285758 Text en © 2023 Rawicz-Pruszyński et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Study Protocol Rawicz-Pruszyński, Karol Sędłak, Katarzyna Pelc, Zuzanna Mlak, Radosław Litwiński, Jakub Mańko, Paweł Zinkiewicz, Krzysztof Paśnik, Iwona Cięszczyk, Katarzyna Pawlik, Timothy Märkl, Bruno Erodotou, Maria Polkowski, Wojciech P. Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study |
title | Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study |
title_full | Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study |
title_fullStr | Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study |
title_full_unstemmed | Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study |
title_short | Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)—Study protocol for a single-arm prospective observational multicenter study |
title_sort | staging laparoscopy to assess lymph node involvement in advanced gastric cancer (pola)—study protocol for a single-arm prospective observational multicenter study |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10198545/ https://www.ncbi.nlm.nih.gov/pubmed/37205666 http://dx.doi.org/10.1371/journal.pone.0285758 |
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