Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02863783
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-06
First Post:
2016-07-31
Brief Title:
EUS Fiducial for Pancreas Surgery
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Pilot Trial of Endoscopic Ultrasound Guided Coil Placement to Facilitate Intraoperative Assessment of Pancreas Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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:
RATIONALE Pancreas tumor localization makes minimally invasive surgical resection of pancreas tumors very challenging Recently an endoscopic ultrasound needle system has been developed which enables fiducial coils to be placed at the precise site of biopsy
INTERVENTION At time of EUS guided biopsy the fine needle fiducial device will be used to place fiducials in the tumor During surgery we will assess whether it improves tumor visualization
OBJECTIVES We aim to determine the feasibility to use EUS guided fiducials placement to mark pancreas tumors in 20 patients and to assess whether the fiducials impact tumor visualization during pancreas surgery
STUDY POPULATION Patients with pancreas adenocarcinoma or neuroendocrine lesions
STUDY ENDPOINTS The main outcome will be to assess whether the coil may be successfully placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and ANALYSIS Patients will be assessed at the time of EUS and surgery This is a pilot analysis with the intention to assess feasibility and to gather data to power larger trials
INTERVENTION At time of EUS guided biopsy the fine needle fiducial device will be used to place fiducials in the tumor During surgery we will assess whether it improves tumor visualization
OBJECTIVES We aim to determine the feasibility to use EUS guided fiducials placement to mark pancreas tumors in 20 patients and to assess whether the fiducials impact tumor visualization during pancreas surgery
STUDY POPULATION Patients with pancreas adenocarcinoma or neuroendocrine lesions
STUDY ENDPOINTS The main outcome will be to assess whether the coil may be successfully placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and ANALYSIS Patients will be assessed at the time of EUS and surgery This is a pilot analysis with the intention to assess feasibility and to gather data to power larger trials
Detailed Description:
Minimally invasive pancreatic surgery diminishes the morbidity and mortality of the potentially curative procedures However precise targeting of small adenocarcinomas and neuroendocrine tumors is challenging
Given safety precision and ease EUS guided pancreatic fiducial placement has emerged as a favored method to mark tumors for radiation therapy The experimental aspect of this procedure is gauge whether EUS guided fiducial placement improves the intraoperative assessment of pancreas tumors We will use the recently introduced FDA approved Beacon EUS guided fiducial system to perform placement The fiducial will not alter the surgical plan in this study However the relative ability to detect the marker during standard pancreatic surgery will help to inform whether this strategy may be used in improve future approaches to pancreas surgery
The study will be a prospective trial All EUS will be performed as part of standard clinical care
Conventional EUSFNA The linear array echoendoscope will be used to identify the pancreas adenocarcinoma and neuroendocrine tumors The Beacon EUS systemdelivery sheath will be passed and fine needle aspiration performed to confirm cytology This is required for standard clinical care The delivery sheath will be left in place The cytologist will perform bedside interpretation as is standard clinical care
EUS guided coil injection If adenocarcinoma or neuroendocrine tumor is confirmed by fine needle aspiration the fine needle fiducial accessory will be passed through the delivery sheath whose position on the tumor is now biopsy confirmed and 1-3 fiducials coil type will be introduced into the lesion This process will be guided by EUS which is being performed for standard clinical care Fluoroscopy not be utilized
Pancreas Surgery At time of surgery the experimental component is that it will be gauged whether the fiducial impacts the ability to assess the tumor relative to lesions of comparable size Whether the fiducial improves or does not improve assessment will be scaled on a 1-10 scale where 5 is the standard ease of detection of similarly sized tumors without fiducials based on the attending surgeons experience
However the fiducial will not be used to target the lesion or alter the surgical plan The surgical plan will be based on preoperative clinical imaging intraoperative findings and intraoperative ultrasound standard clinical care The research coordinator will be present during surgery to facilitate timely acquisition of data In some cases patient are deemed to not be resection candidates at the time of surgery if for example unexpected metastasis are found The EUS guided fiducial placement will have no bearing on whether resection is done or not
Given safety precision and ease EUS guided pancreatic fiducial placement has emerged as a favored method to mark tumors for radiation therapy The experimental aspect of this procedure is gauge whether EUS guided fiducial placement improves the intraoperative assessment of pancreas tumors We will use the recently introduced FDA approved Beacon EUS guided fiducial system to perform placement The fiducial will not alter the surgical plan in this study However the relative ability to detect the marker during standard pancreatic surgery will help to inform whether this strategy may be used in improve future approaches to pancreas surgery
The study will be a prospective trial All EUS will be performed as part of standard clinical care
Conventional EUSFNA The linear array echoendoscope will be used to identify the pancreas adenocarcinoma and neuroendocrine tumors The Beacon EUS systemdelivery sheath will be passed and fine needle aspiration performed to confirm cytology This is required for standard clinical care The delivery sheath will be left in place The cytologist will perform bedside interpretation as is standard clinical care
EUS guided coil injection If adenocarcinoma or neuroendocrine tumor is confirmed by fine needle aspiration the fine needle fiducial accessory will be passed through the delivery sheath whose position on the tumor is now biopsy confirmed and 1-3 fiducials coil type will be introduced into the lesion This process will be guided by EUS which is being performed for standard clinical care Fluoroscopy not be utilized
Pancreas Surgery At time of surgery the experimental component is that it will be gauged whether the fiducial impacts the ability to assess the tumor relative to lesions of comparable size Whether the fiducial improves or does not improve assessment will be scaled on a 1-10 scale where 5 is the standard ease of detection of similarly sized tumors without fiducials based on the attending surgeons experience
However the fiducial will not be used to target the lesion or alter the surgical plan The surgical plan will be based on preoperative clinical imaging intraoperative findings and intraoperative ultrasound standard clinical care The research coordinator will be present during surgery to facilitate timely acquisition of data In some cases patient are deemed to not be resection candidates at the time of surgery if for example unexpected metastasis are found The EUS guided fiducial placement will have no bearing on whether resection is done or not
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None