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

NCT02181140 | Completed Results DMC

• 1 other identifier: PV 3835
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  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 Outcomes (2)

• EUS Pro Core FNA: Histology Samples

  day 0 and day 14

• Complication Rates

  day 0 and day 14

Study Arms (1)

EUS guided FNA and fine needle punction

OTHER

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

Interventions

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

EUS guided FNA and fine needle punction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (23)

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• Sudhoff T, Hollerbach S, Wilhelms I, Willert J, Reiser M, Topalidis T, Schmiegel W, Graeven U. [Clinical utility of EUS-FNA in upper gastrointestinal and mediastinal disease]. Dtsch Med Wochenschr. 2004 Oct 15;129(42):2227-32. doi: 10.1055/s-2004-831867. German.

  PMID: 15483756 BACKGROUND

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  PMID: 17620230 BACKGROUND

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  PMID: 16417562 BACKGROUND

• Shah SM, Ribeiro A, Levi J, Jorda M, Rocha-Lima C, Sleeman D, Hamilton-Nelson K, Ganjei-Azar P, Barkin J. EUS-guided fine needle aspiration with and without trucut biopsy of pancreatic masses. JOP. 2008 Jul 10;9(4):422-30.

  PMID: 18648133 BACKGROUND

• Storch I, Shah M, Thurer R, Donna E, Ribeiro A. Endoscopic ultrasound-guided fine-needle aspiration and Trucut biopsy in thoracic lesions: when tissue is the issue. Surg Endosc. 2008 Jan;22(1):86-90. doi: 10.1007/s00464-007-9374-x. Epub 2007 May 4.

  PMID: 17479313 BACKGROUND

• Storch I, Jorda M, Thurer R, Raez L, Rocha-Lima C, Vernon S, Ribeiro A. Advantage of EUS Trucut biopsy combined with fine-needle aspiration without immediate on-site cytopathologic examination. Gastrointest Endosc. 2006 Oct;64(4):505-11. doi: 10.1016/j.gie.2006.02.056. Epub 2006 Jun 6.

  PMID: 16996340 BACKGROUND

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  PMID: 27818598 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Professor Dr. Thomas Rösch
• Organization: Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf

t.roesch@uke.de

+4940 7410

Study Officials

• Thomas Rösch, Prof. Dr.

  University Hospital Eppendorf, Hamburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Interdisciplinary Endoscopy Department and Clinic

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 3, 2014
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 18, 2019
• Results First Posted: September 16, 2015

Record last verified: 2019-04

Locations

DE (1)