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Trial record 15 of 2068 for:    Pancreatic Cancer AND Digestive System Neoplasms

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

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ClinicalTrials.gov Identifier: NCT02181140
Recruitment Status : Completed
First Posted : July 3, 2014
Results First Posted : September 16, 2015
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasm Device: EUS guided FNA and fine needle punction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes
Study Start Date : August 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181140


Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Thomas Rösch, Prof. Dr. University Hospital Eppendorf, Hamburg

Publications of Results:
Other Publications:

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Responsible Party: Prof. Dr. Thomas Rösch, Medical Director, Interdisciplinary Endoscopy Department and Clinic, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02181140     History of Changes
Other Study ID Numbers: PV 3835
First Posted: July 3, 2014    Key Record Dates
Results First Posted: September 16, 2015
Last Update Posted: June 18, 2019
Last Verified: April 2019
Keywords provided by Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf:
fine needle aspiration
core biopsy
endoscopic ultrasound
space occupying process mediastinal, perigastral, perihilar
suspect lymph nodes mediastinal, perigastral or perihilar
diagnostic accuracy of EUS guided core biopsy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases