EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
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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. |
- 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.
- 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:
|
|
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:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 2X8 | |
| Royal Alexandria Hospital | |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| 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 Adenocarcinoma, Mucinous Neoplasms Lymphoma Pancreatic Neoplasms Gastrointestinal Stromal Tumors Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gastrointestinal Neoplasms Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013