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Completed

NCT Number: NCT01936467

Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions

The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.

There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.

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Key information

Conditions

Pancreatic Solid Lesions Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Mass Pancreatic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA

Exclusion criteria

  • Uncorrectable coagulopathy (INR > 1.5)
  • Uncorrectable thrombocytopenia (platelet < 50,000)
  • Uncooperative patients
  • Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
  • Refusal to consent form
  • Cystic lesions
  • Inaccessible lesions to EUS

Treatment and study plan

Standard technique EUS-FNA

Device

Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Capillary suction technique for EUS FNA

Device

Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Primary outcomes

  1. Diagnostic Yield of Capillary Technique

    Time frame: up to 6 months

    Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

  2. Diagnostic Yield of Standard Technique

    Time frame: up to 6 months

    Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

  3. Sensitivity of EUS-FNA With Capillary Technique

    Time frame: 6 months

    Sensitivity of the EUS-FNA with Capillary technique

  4. Sensitivity of EUS-FNA With StandardTechnique

    Time frame: 6 months

    Sensitivity of the EUS-FNA with Capillary technique

  5. Sensitivity of EUS-FNA

    Time frame: 6 months

    Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions

Secondary outcomes

  1. First Pass Diagnostic Rate

    Time frame: immediate

    The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass

  2. Acquisition of Core Tissue

    Time frame: immediate

    The rate of acquiring core tissue of the pancreatic mass through EUS-FNA

  3. Diagnostic Accuracy of EUS-FNA

    Time frame: 6 months

    The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 6, 2013
Registry last updated
Apr 13, 2017

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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