Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05069766
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2021-09-15
Brief Title:
Preoperative Marking of the Oral Resection Margin in Esophageal Cancer With a Surgical Fiducial Marker - First Experiences
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Preoperative Marking of the Oral Resection Margin in Esophageal Cancer With a Surgical Fiducial Marker - First Experiences
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
This study aims to evaluate if BioXmark a surgical marker may efficiently and safely be used to preoperatively mark the proximal and distal resection line 5 cm proximal and distal to the tumor margin of gastroesophageal-junction adenocarcinoma GEJ AC
Furthermore to determine if placing the resection margin according to the resection margin defined by BioXmark is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings
Furthermore to determine if placing the resection margin according to the resection margin defined by BioXmark is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings
Detailed Description:
In Denmark the national guidelines for GEJ AC surgery are an R0 resection with a minimum 5 cm proximal and distal resection margin measured in vivo During the operation the primary surgeon sets the resection margin according to the guidelines with 5 cm on either side
The Danish national guidelines are clear but the literature behind them is not and the recommendations for resection margins vary worldwide With the lack of a strong literature-backed guideline and a surgical approach that is heavily dependent on the individual surgeons estimate the risk of a microscopic positive resection margin R1 resection increases Both problems namely resectability at the definitive surgery and the incidence of microscopic positive resection margins after resection may be improved by preoperatively marking the tumor margins in vivo This could be achieved with an endoscopically placed surgical marker
One such surgical marker is BioXmark a liquid injectable and adherent fiducial marker that has shown promising results for image-guided adaptive radiotherapy in lung bladder and esophageal cancer BioXmark is implanted during endoscopy and has appropriate visibility with good positional stability on CT CBCT and MRI Furthermore no adverse reactions or events have been reported yet
The study will be performed as a feasibility study of BioXmark at the Department of Surgery Transplantation Centre of Cancer and Organ Diseases The investigators plan to include 10 patients who are scheduled to undergo curatively intended surgery for GEJ AC The patients will be drawn from the existing operating program
The Danish national guidelines are clear but the literature behind them is not and the recommendations for resection margins vary worldwide With the lack of a strong literature-backed guideline and a surgical approach that is heavily dependent on the individual surgeons estimate the risk of a microscopic positive resection margin R1 resection increases Both problems namely resectability at the definitive surgery and the incidence of microscopic positive resection margins after resection may be improved by preoperatively marking the tumor margins in vivo This could be achieved with an endoscopically placed surgical marker
One such surgical marker is BioXmark a liquid injectable and adherent fiducial marker that has shown promising results for image-guided adaptive radiotherapy in lung bladder and esophageal cancer BioXmark is implanted during endoscopy and has appropriate visibility with good positional stability on CT CBCT and MRI Furthermore no adverse reactions or events have been reported yet
The study will be performed as a feasibility study of BioXmark at the Department of Surgery Transplantation Centre of Cancer and Organ Diseases The investigators plan to include 10 patients who are scheduled to undergo curatively intended surgery for GEJ AC The patients will be drawn from the existing operating program
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