EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Teshima, University of Alberta
ClinicalTrials.gov Identifier:
NCT01774162
First received: January 18, 2013
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many gastrointestinal conditions, including but not limited to, malignant and pre-malignant neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the gastrointestinal tract. EUS is the most sensitive test for the detection of focal lesions within the pancreas and is the most accurate method for diagnosing pancreas cancer. A biopsy method for tissue sampling via EUS called fine needle aspiration (FNA) was developed that enables a small needle to be passed into the lesion of interest under ultrasound guidance, obtaining cellular material for cytology. EUS-FNA is currently recommended for the diagnosis of cystic and solid mass lesions within and adjacent to the gastrointestinal tract. Yet in certain clinical circumstances, it is more desirable and sometimes necessary to obtain a core tissue biopsy for histology rather than the cellular material for cytology obtained with EUS-FNA. Furthermore, histology may generally increase the diagnostic yield of EUS-FNA compared to cytology. It is with these aims in mind that a new type of needle, the fine needle biopsy (EUS-FNB) device was developed to enable core tissue sampling. Since a comparison of these to methods has yet to be made, the aim of this study is to perform a direct comparison of the sampling adequacy and diagnostic yield of the new EUS-FNB needle with the conventional EUS-FNA needle.


Condition Intervention
Pancreas Adenocarcinoma
Pancreas Neoplasms
Gastrointestinal Stromal Tumor
Lymphoma
Device: Fine needle biopsy using ProCore needle for histology.
Device: Fine needle aspiration using conventional FNA for cytology

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endoscopic Ultrasound Guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration.

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Sampling Adequacy [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
    The ability of the pathologist to provide a definitive diagnostic interpretation (definitely positive, definitely negative or indeterminate reading) based on the tissue provided for a given lesion of interest.


Secondary Outcome Measures:
  • Sampling adequacy by lesion subtype [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
    The sampling adequacy as defined in the primary outcome measure stratified by lesion subtype (pancreas, other intra-abdominal mass, liver mass, submucosal tumor, lymph node)

  • Diagnostic yield [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
    The diagnosis obtained by FNA or FNB needle compared to the final diagnosis made by either FNA or FNB needle, subsequent surgery, or expert consensus at the end of the data collection period

  • Diagnostic yield by lesion subtype [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
    The diagnosis obtained by the FNA or FNB needle compared to the final diagnosis obtained by either FNA or FNB needle, subsequent surgery or expert consensus regarding clinical diagnosis at the end of the data collection period.

  • Diagnostic agreement between FNA and FNB needles [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
    The measure of agreement between diagnoses obtained by FNA and FNB needles for assessment of metastatic lymph nodes

  • Adverse events [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
    Any adverse events including bleeding, fever, infection, pancreatitis, EUS-induced perforation, and sedation related complications occurring after both FNA and FNB biopsies.


Enrollment: 57
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FNA for cytology
Fine needle aspiration using conventional FNA for cytology
Device: Fine needle aspiration using conventional FNA for cytology
EUS-guided biopsy of each solid lesion using the EchoTip® Ultra™ FNA needle for cytology.
Other Names:
  • EchoTip® Ultra™ FNA needle
  • Fine needle aspiration
Experimental: FNB core biopsy for histology
Fine needle biopsy using ProCore needle for histology.
Device: Fine needle biopsy using ProCore needle for histology.
EUS-guided biopsy of each solid lesion using the EchoTip® ProCore™ ultrasound FNB needle for histology.
Other Names:
  • EchoTip® ProCore™ ultrasound FNB needle
  • Fine needle biopsy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient 18 years or older
  • Able to read and write English
  • Undergoing EUS for the evaluation of: i) pancreas mass ii) intra-abdominal mass iii) suspected submucosal tumor iv) esophageal cancer staging v) other lymph node assessment

Exclusion Criteria:

  • No detectable lesion
  • lesion inaccessible to EUS guided biopsy
  • Lesion determined to not require tissue sampling
  • Pancreas lesion is predominantly cystic
  • coagulopathy with a known clotting factor deficiency or an uncorrectable INR > 1.5, PTT > 40, platelet count < 50,000
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774162

Locations
Canada, Alberta
Royal Alexandria Hospital
Edmonton, Alberta, Canada, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Christopher W Teshima, MD,FRCPC University of Alberta
  More Information

Publications:

Responsible Party: Christopher Teshima, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01774162     History of Changes
Other Study ID Numbers: Pro00022017
Study First Received: January 18, 2013
Last Updated: January 22, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Endoscopic Ultrasound
Fine needle aspiration
Fine needle biopsy
ProCore

Additional relevant MeSH terms:
Adenocarcinoma
Gastrointestinal Stromal Tumors
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014