NCT03017599

Brief Summary

To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

July 11, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

January 10, 2017

Last Update Submit

May 17, 2018

Conditions

Pancreatic CancerSolid Pancreatic and Peripancreatic Lesion

Outcome Measures

Primary Outcomes (2)

  • Procurement of the histologic core

    The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures

    7 days after the procedure

  • Diagnostic accuracy

    \[Standard diagnosis\] * In operated patients; based on the surgical resection specimen * In non-operated patients; based on the conclusions of the diagnostic work-up and confirmed by a compatible clinical disease course

    7 days after the procedure

Secondary Outcomes (1)

  • Technical success

    7 days after the procedure

Study Arms (1)

Intervention group

EXPERIMENTAL

EUS-FNB using 20-gauge procore needle

Device: 20-gauge ProCore FNB needle

Interventions

20-gauge ProCore FNB needleDEVICE

The investigators will prospectively collect data base including patients who underwent EUS-guided biopsy with the 20-gauge ProCore histology needle for the evaluation of Pancreatic solid mass. EUS procedures will be performed under sedation with linear echoendoscopes. Once the lesion will be penetrated, the stylet will be removed, and suction will be applied for 10 to 20 seconds by using a 10-ml syringe while moving the needle to and fro. All samples will processed at the pathology departments for histological analysis with documentation.

Also known as: 20G Echotip ProCore Fine Needle Biopsy (FNB) device(Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
Intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who are at least 20 years of age
  • patients who require endoscopic ultrasound-guided fine needle aspiration cytology or biopsy because of pancreatic or peripancreatic solid mass.

You may not qualify if:

  • Cystic pancreatic mass in imaging tests such as CT or MRI or US
  • haemodynamically unstable patients
  • severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\])
  • patients unable to quit anticoagulant/anti-platelet therapy
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Related Publications (2)

  • Lee JH, Stewart J, Ross WA, Anandasabapathy S, Xiao L, Staerkel G. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci. 2009 Oct;54(10):2274-81. doi: 10.1007/s10620-009-0906-1. Epub 2009 Aug 11.

    PMID: 19669880BACKGROUND

  • Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.

    PMID: 19640524BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 11, 2017

Study Start

July 11, 2016

Primary Completion

July 10, 2017

Study Completion

July 10, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)