Pancreatic tumors Pancreatic Neoplasms
Conditions
Interventions
The order of puncture needles to be used will be randomly assigned in endoscopic ultrasound-guided tissue sampling (EUS-TA) of pancreatic mass lesions as follows:
(1) 1st: novel puncture needle (Centu
Sponsors
Hiroshi Ohyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following conditions are eligible 1) Persons who are 20 years of age or older at the time of obtaining consent 2) Patients with pancreatic mass lesions eligible for EUS-TA 3) Patients who have been fully informed of the study and given written consent of their own free will based on a thorough understanding of the study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions are not eligible 1) ECOG Performance Status 3 or higher 2) Bleeding risk with HAS-BLED score of 3 or higher or platelet count less than 50,000/mm3 3) Receiving two or more antithrombotic agents 4) Presence of a pancreatic mass undetectable by EUS 5) Pregnancy 6) Refusal to participate 7) Patients deemed by the study investigator or sub-investigator to be unsuitable for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of tissue scores of 5 for both conventional and novel puncture needle specimens, following a previous report that defined a tissue score of 5 as one of high quality and sufficient for histological assessment (total tissue sample > x10 power field in length) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Tissue area of each specimen obtained with the conventional and novel puncture needle -Percentage of tumor cells in each of the conventional and novel puncture needles -Blood contamination rate of conventional and novel puncture needles -Puncture performance of the conventional and novel puncture needles -Treatment time for the conventional and novel puncture needles -Frequency of adverse events after testing with the conventional and novel puncture needles | — |
Contacts
Public ContactOhyama Hiroshi
Chiba University Hospital
Outcome results
None listed