Comparison of FNB to EUS-CNB for Pancreatic Lesions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of California, Davis
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
endoscopic ultrasound guided biopsy with core needle biopsy device
DeviceThe 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.
EUS-FNB
Procedure/SurgeryBiopsy obtain via EUS-FNB
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: EUS-FNBActive comparator 1 intervention
Group B: EUS-CNBExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic specimen
The percentage of cases achieving an adequate diagnostic yield (defined as a cellularity score of ≥2) after a single needle pass with either the EndoDrill or the 22-G FNB device
Time frame
during study interventionSecondary outcomes
1
Blood contamination of the specimen
Blood contamination of the biopsy specimen obtained from the first needle pass with either the EndoDrill or 22-G FNB, assessed using the following scoring system, in which higher numerical scores correspond to a lower degree of blood contamination and, consequently, superior biopsy specimen quality: 0: Only blood 1. Blood contamination in more than 50% of the slide 2. Blood contamination from 25 to 50% of the slide 3. Blood contamination in less than 25% of the slide
Time frame
during study intervention2
cellularity score
Cellularity score of the biopsy specimen obtained from the first needle pass with either the EndoDrill or 22-G FNB, based on the following grading scale, in which higher numerical scores indicate superior biopsy specimen quality: 0: Insufficient material. The sample is inadequate for interpretation. 1. Limited cytologic interpretation. There is some material, but it is insufficient for a reliable diagnosis. 2. Adequate cytologic interpretation. Sufficient cellular material is available for a basic cytologic diagnosis. 3. Limited histologic assessment. Allows for a limited evaluation of tissue architecture. 4. Adequate histologic interpretation. The sample contains sufficient tissue to evaluate the lesion's histology. The total tissue length may be within a single microscopic field. 5. Excellent histologic interpretation. The sample contains a substantial amount of tissue core, exceeding the length of a single microscopic field.
Time frame
during study intervention3
Procedure Duration
duration in minutes of the procedure
Time frame
during study interventionSponsors and contacts
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Source ClinicalTrials.gov
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