Health Trials

About this trial

The primary aim of this study is to compare the tissue specimen quality and diagnostic accuracy of biopsies obtained with one puncture of a regular 22 FNB G needle and the motorized EUS CNB device of pancreatic lesions. The secondary aims are to compare the rate of blood contamination in the specimens obtained from biopsies of pancreatic lesions and the overall procedure duration. The hypothesis of this study is that the proportion of cases in which a single puncture of the lesion in question delivers adequate diagnostic tissue is higher with the motorized EUS CNB than with the 22 G FNB.

Eligibility criteria

Qualifiers

Patients who require EUS and tissue sampling of pancreatic solid lesions (size> 2.5 cm)

Patients who can give consent

Disqualifiers

patients without pancreatic lesions

Pregnant females

Hematologic and Coagulation disorders (platelets < 50,000/mm3, INR > 2, ANC <1000)

Patients with acute pancreatitis in the immediate 2 weeks before the procedure (if the lesion to be biopsied is in the pancreas)

Trial design

Treatments tested in this trial

  • endoscopic ultrasound guided biopsy with core needle biopsy device
  • EUS-FNB

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1
UC Davis Medical Center95817, SacramentoCalifornia, United States

Sponsors and collaborators

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov