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Trial record 15 of 2066 for:    Pancreatic Cancer AND Digestive System Neoplasms

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Pancreatic Neoplasm
Intervention Device: EUS guided FNA and fine needle punction
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EUS Guided FNA and Fine Needle Punction
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punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order

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

Period Title: Overall Study
Started 56
Completed 56
Not Completed 0
Arm/Group Title EUS Guided FNA and Fine Needle Punction
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punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order

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

Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 56 participants
67.5
(34 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
27
  48.2%
Male
29
  51.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 56 participants
56
1.Primary Outcome
Title Diagnostic Accuracy
Hide Description

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.

Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EUS Guided Pro Core FNA
Hide Arm/Group Description:
EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Diagnostic accuracy (%)
84
2.Secondary Outcome
Title EUS Pro Core FNA: Histology Samples
Hide Description Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples
Time Frame day 0 and day 14
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Hide Analysis Population Description
Histology (not cytology) samples for Pro-core Needle
Arm/Group Title EUS Guided Pro Core FNA
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EUS guided Pro core FNA: Histology samples (not cytology)
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants
36
3.Secondary Outcome
Title Complication Rates
Hide Description Complication rates of EUS FNA
Time Frame day 0 and day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EUS Guided FNA
Hide Arm/Group Description:
EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants
0
Time Frame 1 fortnight
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EUS Guided FNA
Hide Arm/Group Description EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
All-Cause Mortality
EUS Guided FNA
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EUS Guided FNA
Affected / at Risk (%)
Total   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EUS Guided FNA
Affected / at Risk (%)
Total   0/56 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Dr. Thomas Rösch
Organization: Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf
Phone: +4940 7410 ext 50098
EMail: t.roesch@uke.de
Other Publications:
Layout table for additonal information
Responsible Party: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02181140     History of Changes
Other Study ID Numbers: PV 3835
First Submitted: July 8, 2013
First Posted: July 3, 2014
Results First Submitted: May 21, 2015
Results First Posted: September 16, 2015
Last Update Posted: June 18, 2019