Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720598
Status:
RECRUITING
Last Update Posted:
2023-02-09
First Post:
2023-01-19
Brief Title:
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer
Sponsor:
Medical University of Lublin
Organization:
Medical University of Lublin
Study Overview
Official Title:
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLA
Brief Summary:
Staging LaParscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer POLA study aims to investigate the safety and feasibility of ICG-guided SN retrieval in GC patients undergoing multimodal treatment The pretreatment clinical variables potentially associated with the procedure will also be analyzed
To the best of our knowledge the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment
To the best of our knowledge the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment
Detailed Description:
Comprehensive lymph node assessment seems to be critical for proper treatment strategy and survival prediction particularly in advanced GC Recent data on the sentinel node SN concept in early GC has shown favorable results regarding LN detection rate and clinical status determination Staging laparoscopy SL with lavage cytology provides an additional value to the clinical staging of GC particularly in detecting occult peritoneal disease The role of Indocyanine green ICG guided SN mapping in GC confirmed its technical feasibility ICG can be safely used to identify SN determine the surgical resection line improve the LN harvest and reduce noncompliance in patients undergoing D2 lymphadenectomy
The majority of the studies focused on the aspect of the increase in LN harvest At the same time no data exist regarding its potential role in GC nodal staging To the best of our knowledge the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment
The majority of the studies focused on the aspect of the increase in LN harvest At the same time no data exist regarding its potential role in GC nodal staging To the best of our knowledge the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None