SharkCore Versus Acquire FNB

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
Subjects will come to a pre‐procedure room on the day of the procedure. The investigator will again go over the risk and benefit of procedure and indication of the procedure. Once the consent form is signed, a large bore IV cannula is placed and the subject will be taken to the DHC procedure room. Once all the team members required to perform the procedure are in the room we will do a time‐out to make sure current patient and procedure are performed. A time‐out is done by asking the subject to tell his full name with date of birth and describe in his own words what procedure is planned for subject today. If all the things match the investigator will go ahead and start the sedation. All EUS‐FNB will be performed in the standard manner using linear echoendoscopes. All EUS‐FNB procedures were performed by 1 of 2 highly experienced endosonographers (Henning Gerke or Rami EL‐Abiad). The needle to be used (SharkCore vs Acquire) will be decided based on randomization software. The needle will then be used to puncture the target lesion in standard fashion. Aspirated cellular materials will be expressed into the slide by advancing the stylet. The remainder will be expressed onto filter paper and submitted for cell block preparation. The subject's medical information including diagnosis, date of diagnosis, date of admission, blood test results, and medications received will be reviewed for analysis.
Epistemonikos ID: 03eff44464bbe01e79a38556b8876d4968d59f9f
First added on: May 21, 2024