NCT01978808

Brief Summary

For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. We hypothesize that a FNA needle with a side port could improve the diagnostic yield. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield in patients with pancreatic masses for evaluation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

October 16, 2013

Last Update Submit

November 11, 2013

Conditions

Pancreatic Tumor

Outcome Measures

Primary Outcomes (1)

  • the overall diagnostic accuracy rate of both needles

    assessment of diagnostic accuracy rate after 26 wks, then annually later

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients referred for EUS-FNA of pancreatic masses

You may qualify if:

  • all patients referred for EUS-FNA of pancreatic masses;
  • informed consent is obtained for performance of EUS-FNA.

You may not qualify if:

  • \. presence of active gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Tsu-Yao Cheng

    Visiting staff

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsu-Yao Cheng

CONTACT

+886-2-23123456tycheng@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

November 8, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

TW(1)