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Completed

NCT Number: NCT02181140

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS guided FNA and fine needle punction

Device

punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Complication Rates

    Time frame: day 0 and day 14

    Complication rates of EUS FNA

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: COS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2014
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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