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

NCT01795066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-03-29

No results posted yet for this study

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.

Conditions

  • Solid Pancreatic Masses

Interventions

DEVICE

EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-01-22
Completion
2015-01-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795066 on ClinicalTrials.gov