Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466902
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-14
Brief Title:
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer PhotoNodes
Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Organization:
Azienda Ospedaliero-Universitaria di Parma
Study Overview
Official Title:
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery PhotoNodes
Status:
RECRUITING
Status Verified Date:
2024-07
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:
PhotoNodes
Brief Summary:
Even after the wide introduction of chemoradiotherapy in the treatment algorithm adequate surgery remains the cornerstone of gastric cancer treatment with curative intent A proper D2 lymphadenectomy is associated with improved cancer specific survival as confirmed in Western countries by fifteen-year follow-up results of Dutch and Italian randomized trials
In clinical practice the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy nonetheless the number of retrieved nodes does not necessarily correlate with residual nodes which intuitively could represent a more reliable marker of surgical adequacy The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes
The goal of this multicentric observational prospective study is to test the reliability of a new score PhotoNodes Score created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopicrobotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection
Ideally this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer
In clinical practice the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy nonetheless the number of retrieved nodes does not necessarily correlate with residual nodes which intuitively could represent a more reliable marker of surgical adequacy The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes
The goal of this multicentric observational prospective study is to test the reliability of a new score PhotoNodes Score created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopicrobotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection
Ideally this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer
Detailed Description:
None
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