A pilot study of safety and adequacy of pancreatic lesion biopsy (Spy Bite)

Purpose

The purpose of this study is to determine the safety and effectiveness of an experimental technique to obtain biopsies of pancreatic lesions. This technique uses biopsy forceps, which are small jaw-like devices that open and close, to also obtain tissue samples for examination and diagnosis. The biopsy forceps will pass through the endoscope that is already in place for the endoscopic ultrasound guided fine needle aspiration procedure, and an additional biopsy will be taken. This technique is experimental because biopsy forceps are routinely used in gastrointestinal endoscopy, but are not routinely used to obtain biopsies of the pancreas.

Keywords: pancreatic cancer, colon cancer, cancer, pancreas, colon

Study Sites

Keck Hospital of USC 90033

 
  • Men & Women
Age icon
18+
 
 
OR
 

What's involved?

Study length

  • 1 visit

Number of visits

  • 1

Prescription

  • None

Procedures

  • Biopsy

Compensation

  • None

Medical cost coverage

  • All tests and procedures provided to you for this study are being paid for by the sponsor.

Why participate?

Medical advances are impossible without volunteers.

Eligibility

Must have

  • Consent to undergo the experimental procedure and allow use of the tissue for experimental purposes.
  • Pancreatic mass by imaging (presence of mass in other organs does not exclude the subject from the study).
  • Appropriate candidate for endoscopic evaluation of the mass as assessed by the gastroenterologist of record.
  • Acceptable PT and PTT within 30 days before procedure, off all anticoagulation medications as per standard of care.

Can't have

  • Bleeding disorder
  • INR > 1.5 uncorrected
  • Pregnant and breast-feeding women

Study Team

Lhn6rvlsekqwsjwhfjft Collaborate with the PI

For questions about this study, contact:

  • IRB number: HS-14-00315
  • Study posted on: February 28, 2017
  • Recruitment period: 2/21/17-2/20/18

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