EUS Fiducial Placement for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults with pancreatic cancer who are set to have surgery. They must be undergoing an endoscopic ultrasound as part of their pre-surgery evaluation and have tumors between 5mm-4cm in size. It's not for those with blood clotting issues, metal allergies, pregnancy, under 18 years old, or diagnosed with pancreatic lymphoma.

Inclusion Criteria

Having coils placed in areas with confirmed cancer cells could be useful.

Fiducial markers will only be placed if the initial evaluation indicates resectability

You are having a special type of ultrasound to check for tumors in your pancreas before surgery.

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Exclusion Criteria

Pregnant

<18 years of age

Your blood's ability to clot is too high.

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Treatment Details

Interventions

EUS with Fiducial (Other)

Trial OverviewThe study tests if placing tiny markers called fiducials into the tumor using a special needle during an endoscopic ultrasound helps surgeons see the tumor better during removal. This will be tried on 20 patients to see if it's feasible and useful for future larger studies.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Fiducial PlacementExperimental Treatment1 Intervention

EUS with Fiducial Placement into Tumor