Tissue Sample Comparison Between 22G FNB Needle and a New EUS Core Needle Biopsy Device for Pancreatic Lesions: A Single Center Prospective Randomized Pilot Trial
University of California, Davis
Summary
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.
Description
This study is planned as a single-blind, parallel-group randomized pilot clinical trial (RCT). After receiving informed consent, the eligible subjects will be randomly assigned to two parallel arms. The first arm will be assigned to the 22 FNB G needle with dry suction technique. The second arm will be assigned to the EUS CNB. 15 patients will be assigned to each group. Patients will be prospectively enrolled until the target sample size has been reached. Patients will be enrolled in a prospective manner at the University of California Davis Medical Center Endoscopy unit. The day of the proce…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients who require EUS and tissue sampling of pancreatic solid lesions (size\> 2.5 cm) 2. Patients who can give consent Exclusion Criteria: 1. patients without pancreatic lesions 2. Pregnant females 3. Hematologic and Coagulation disorders (platelets \< 50,000/mm3, INR \> 2, ANC \<1000) 4. Patients with acute pancreatitis in the immediate 2 weeks before the procedure (if the lesion to be biopsied is in the pancreas) 5. Cardiorespiratory dysfunction that precludes sedation 6. patients unable to provide informed consent 7. Previous chemotherapy or radiotherapy for a p…
Interventions
- Deviceendoscopic ultrasound guided biopsy with core needle biopsy device
The EUS-CBD (Endodrill, Bibb Medical, Lund Sweden) differs from currently available needles (FNB) in that it obtains tissue by drilling into target lesions rather than puncturing them.
- ProcedureEUS-FNB
Biopsy obtain via EUS-FNB
Location
- UC Davis Medical CenterSacramento, California