EUS Fiducial for Pancreas Surgery
Status unconfirmed · Not applicable
Conditions studied: Pancreatic Neoplasms
In brief
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.
Key facts
- Study ID
- NCT02863783
- Run by
- University of Southern California
- People needed
- 20
- Starts
- 2016-11-23
- Expected to finish
- 2024-02-01
- Last updated by the study team
- 2023-03-06
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing endoscopic ultrasound for preoperative evaluation before planned pancreatic surgery for suspected adenocarcinoma and neuroendocrine tumors will be eligible. Rapid onsite evaluation is performed for all pancreas EUS as part of standard procedures. In this process the cytologist examines the cells and makes a determination whether the aspirate contains malignant or benign tissue. Fiducials will only be placed if cytologic confirmation of malignancy at the site is obtained.
- Tumors of sizes 5mm-4cm will be eligible as there may be benefit in marking small tumors given difficulty finding them with intraoperative ultrasound. Moderately large pancreas tumors may also cause fibrosis which makes identification for resection difficult. Coil placement in regions of cytologically confirmed malignant cells may be helpful. Fiducial markers will only be placed if the initial evaluation (abdominal computed tomography or magnetic resonance imaging) indicates resectability. If finding of nonresectability (i.e. liver metastasis) are seen on EUS then fiducials will not be placed.
You may not qualify if…
- 1) Patients with INR >1.5 2) Platelet county <100 3) Metal allergy 4) Pregnant 5) <18 years of age 6) Patients with pancreatic lymphoma will also be excluded as this is treated with chemotherapy.
Where it is running
- Los Angeles County Hospital — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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