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Yield Rate for Procurement the Histologic Core With Endoscopic Ultrasound-guided Fine Needle Biopsy With 20-gauge Ultrasound Biopsy Needles for Solid Pancreatic Masses: Pilot Study

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. Identifier: NCT03017599
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : May 22, 2018
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Solid Pancreatic and Peripancreatic Lesion Device: 20-gauge ProCore FNB needle Not Applicable

Detailed Description:

Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis.

Regarding the diagnosis of pancreatic cancer, proper tool with high diagnostic yield is very important. The investigators investigated the technical feasibility and diagnostic yield of recent-developed new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.

The investigators applied the 20-gauge procore needle for EUS-guided fine needle biopsy in the diagnosis of pancreatic solid mass. A total of 30 patients will be enrolled for the present pilot study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : July 11, 2016
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Intervention group
EUS-FNB using 20-gauge procore needle
Device: 20-gauge ProCore FNB needle

The investigators will prospectively collect data base including patients who underwent EUS-guided biopsy with the 20-gauge ProCore histology needle for the evaluation of Pancreatic solid mass.

EUS procedures will be performed under sedation with linear echoendoscopes. Once the lesion will be penetrated, the stylet will be removed, and suction will be applied for 10 to 20 seconds by using a 10-ml syringe while moving the needle to and fro. All samples will processed at the pathology departments for histological analysis with documentation.

Other Name: 20G Echotip ProCore Fine Needle Biopsy (FNB) device(Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Primary Outcome Measures :
  1. Procurement of the histologic core [ Time Frame: 7 days after the procedure ]
    The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures

  2. Diagnostic accuracy [ Time Frame: 7 days after the procedure ]

    [Standard diagnosis]

    • In operated patients; based on the surgical resection specimen
    • In non-operated patients; based on the conclusions of the diagnostic work-up and confirmed by a compatible clinical disease course

Secondary Outcome Measures :
  1. Technical success [ Time Frame: 7 days after the procedure ]
    Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients who are at least 20 years of age
  • patients who require endoscopic ultrasound-guided fine needle aspiration cytology or biopsy because of pancreatic or peripancreatic solid mass.

Exclusion Criteria:

  • Cystic pancreatic mass in imaging tests such as CT or MRI or US
  • haemodynamically unstable patients
  • severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3])
  • patients unable to quit anticoagulant/anti-platelet therapy
  • pregnancy

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 identifier (NCT number): NCT03017599

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Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University Identifier: NCT03017599    
Other Study ID Numbers: 4-2016-0429
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No