Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle (COS)

June 5, 2019 updated by: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes

The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS aspiration needle in GI-tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic ultrasound is an established examination method for tumors of the gastrointestinal tract and the pancreas. Since imaging by itself is limited in differential diagnosis of tumors, EUS guided fine needle aspiration is seen as a valid complementary method. Since fine-needle aspiration (FNA) is mainly based on cytological diagnostics, this method is limited also because of lacking supplementary immune- histochemical diagnostics. Here, the obtainment of little histologically evaluable tissue samples (punched barrels) would be of benefit.

A new punch needle device called Pro-core needle (Cook)(22 / 19 gauges) offers the possibility of increasing numbers of valid extractions of histologically evaluable tissues due to a better targeted precision and maneuverability in comparison to other devices of that kind (tru-cut needles, e.g.). A little notch at the pinpoint allows the obtainment of little tissue samples, that will be kept within the device by aspiration.

This study compares the obtainment of tissue by Proc-core needle and conventional aspiration punction systems.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical indication for endoscopic ultrasound diagnostics with fine needle biopsies
  • age greater than 18 years

Exclusion Criteria:

  • difficult or impossible approach to desired structures due to anatomy (postoperative anatomy, e.g.)
  • cystic lesion, e.g. cystic pancreas tumors
  • coagulopathy
  • severe general condition of the patient
  • other contraindications for endoscopical ultrasound aided fine needle punction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EUS guided FNA and fine needle punction
punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
Device: EUS guided FNA and fine needle punction
punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy
Time Frame: up to 1 year

Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts.

The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard.
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EUS Pro Core FNA: Histology Samples
Time Frame: day 0 and day 14
Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples
day 0 and day 14
Complication Rates
Time Frame: day 0 and day 14
Complication rates of EUS FNA
day 0 and day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Thomas Rösch, Prof. Dr., University Hospital Eppendorf, Hamburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV 3835

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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