Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses

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.

Study Overview

• Status: Completed
• Conditions: Solid Pancreatic Masses
• Intervention / Treatment: Device: EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-FNB with 25-gauge	Device: EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland); Other Names: EUS-FNA with the use of Wilson-Cook procore 25-gauge needles (Echotip, Wilson-Cook, Winston Salem, NC, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accessing the rate for procurement of the histologic core	The tissue samples were immediately fixed in formalin. The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core. If the histologic core was present, the specimen was graded as optimal or suboptimal. Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings. Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture. When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10	up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation of 25-gauge biopsy needle	The tissue samples were immediately fixed in formalin. The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core. If the histologic core was present, the specimen was graded as optimal or suboptimal. Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings. Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture. When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10	up to 5 minuites after after endoscopic ultrasound-guided fine needle biopsy

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 22, 2015
• Study Completion (Actual): January 22, 2015

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 16, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 4-2012-0856