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

NCT01774162 | Completed

• 1 other identifier: Pro00022017
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreas Adenocarcinoma; Pancreas Neoplasms; Gastrointestinal Stromal Tumor; Lymphoma

Keywords

Endoscopic Ultrasound; Fine needle aspiration; Fine needle biopsy; ProCore

Outcome Measures

Primary Outcomes (1)

• Sampling Adequacy

  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.

  at time of procedure

Secondary Outcomes (5)

• Sampling adequacy by lesion subtype

  at time of procedure

• Diagnostic yield

  at time of procedure

• Diagnostic yield by lesion subtype

  at time of procedure

• Diagnostic agreement between FNA and FNB needles

  at time of procedure

• Adverse events

  at time of procedure

Study Arms (2)

FNA for cytology

ACTIVE COMPARATOR

Fine needle aspiration using conventional FNA for cytology

Device: Fine needle aspiration using conventional FNA for cytology

FNB core biopsy for histology

EXPERIMENTAL

Fine needle biopsy using ProCore needle for histology.

Device: Fine needle biopsy using ProCore needle for histology.

Interventions

Fine needle biopsy using ProCore needle for histology. DEVICE

EUS-guided biopsy of each solid lesion using the EchoTip® ProCore™ ultrasound FNB needle for histology.

Also known as: EchoTip® ProCore™ ultrasound FNB needle, Fine needle biopsy

FNB core biopsy for histology

Fine needle aspiration using conventional FNA for cytology DEVICE

EUS-guided biopsy of each solid lesion using the EchoTip® Ultra™ FNA needle for cytology.

Also known as: EchoTip® Ultra™ FNA needle, Fine needle aspiration

FNA for cytology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

Royal Alexandria Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

Location

Related Publications (31)

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MeSH Terms

Conditions

Pancreatic Neoplasms; Gastrointestinal Stromal Tumors; Lymphoma

Interventions

Biopsy, Fine-Needle; Cytological Techniques

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Christopher W Teshima, MD,FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 23, 2013
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

CA (2)