Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)-Study protocol for a single-arm prospective observational multicenter study.
<h4>Introduction</h4>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...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2023-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0285758 |
| _version_ | 1827923595783831552 |
|---|---|
| author | Karol Rawicz-Pruszyński Katarzyna Sędłak Zuzanna Pelc Radosław Mlak Jakub Litwiński Paweł Mańko Krzysztof Zinkiewicz Iwona Paśnik Katarzyna Cięszczyk Timothy Pawlik Bruno Märkl Maria Erodotou Wojciech P Polkowski |
| author_facet | Karol Rawicz-Pruszyński Katarzyna Sędłak Zuzanna Pelc Radosław Mlak Jakub Litwiński Paweł Mańko Krzysztof Zinkiewicz Iwona Paśnik Katarzyna Cięszczyk Timothy Pawlik Bruno Märkl Maria Erodotou Wojciech P Polkowski |
| author_sort | Karol Rawicz-Pruszyński |
| collection | DOAJ |
| description | <h4>Introduction</h4>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.<h4>Materials and methods</h4>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.<h4>Conclusion</h4>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. |
| first_indexed | 2024-03-13T04:59:57Z |
| format | Article |
| id | doaj.art-a74c6f52b8a84957a26d3eecb51b27c6 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-03-13T04:59:57Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-a74c6f52b8a84957a26d3eecb51b27c62023-06-17T05:31:13ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01185e028575810.1371/journal.pone.0285758Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)-Study protocol for a single-arm prospective observational multicenter study.Karol Rawicz-PruszyńskiKatarzyna SędłakZuzanna PelcRadosław MlakJakub LitwińskiPaweł MańkoKrzysztof ZinkiewiczIwona PaśnikKatarzyna CięszczykTimothy PawlikBruno MärklMaria ErodotouWojciech P Polkowski<h4>Introduction</h4>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.<h4>Materials and methods</h4>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.<h4>Conclusion</h4>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.https://doi.org/10.1371/journal.pone.0285758 |
| spellingShingle | Karol Rawicz-Pruszyński Katarzyna Sędłak Zuzanna Pelc Radosław Mlak Jakub Litwiński Paweł Mańko Krzysztof Zinkiewicz Iwona Paśnik Katarzyna Cięszczyk Timothy Pawlik Bruno Märkl Maria Erodotou Wojciech P Polkowski Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)-Study protocol for a single-arm prospective observational multicenter study. PLoS ONE |
| 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 |
| url | https://doi.org/10.1371/journal.pone.0285758 |
| work_keys_str_mv | AT karolrawiczpruszynski staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT katarzynasedłak staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT zuzannapelc staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT radosławmlak staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT jakublitwinski staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT pawełmanko staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT krzysztofzinkiewicz staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT iwonapasnik staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT katarzynacieszczyk staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT timothypawlik staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT brunomarkl staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT mariaerodotou staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy AT wojciechppolkowski staginglaparoscopytoassesslymphnodeinvolvementinadvancedgastriccancerpolastudyprotocolforasinglearmprospectiveobservationalmulticenterstudy |