Clinical trial NCT01795066: Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Pancreatic Masses
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: For 12 months after approvement by the University of Yonsei institutional review board, of the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies with need of histologic tissue confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the following: cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study. Patients undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued treatment at least 5 days before the endoscopic procedure. Written informed consent was obtained from all patients for the procedures performed and participation in the study, and the study protocol was approved by the University of Yonsei institutional review board. All patients were underwent the procedure under conscious sedation with propofol and midazolam according to the current guidelines.8 After procedure, the patients were monitored for at least six hours in order to immediately detect post-procedural complications and were followed for up to 7 days in order to detect late complications.


Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years referred to our medical center for EUS-FNA or FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies

Exclusion Criteria:

* cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.

Primary outcomes:
measure: accessing the rate for procurement of the histologic core
timeFrame: up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy
Secondary outcomes:
measure: the percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation of 25-gauge biopsy needle
timeFrame: up to 5 minuites after after endoscopic ultrasound-guided fine needle biopsy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
Study officials:
References:
citation: Park SW, Chung MJ, Lee SH, Lee HS, Lee HJ, Park JY, Park SW, Song SY, Kim H, Chung JB, Bang S. Prospective Study for Comparison of Endoscopic Ultrasound-Guided Tissue Acquisition Using 25- and 22-Gauge Core Biopsy Needles in Solid Pancreatic Masses. PLoS One. 2016 May 5;11(5):e0154401. doi: 10.1371/journal.pone.0154401. eCollection 2016.