Clinical trialNACompleted
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- September 2012
- Expected end
- February 2014
- Enrollment
- 140 participants
- Sites
- 3
- Primary outcomes
- Diagnostic Yield of EUS-FNB and EUS-FNA
- Sponsor
- Other
- Results posted
- 2015-03-18
- Last update
- 18 January 2018
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Brief summary public domain (ClinicalTrials.gov)
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
Detailed description public domain (ClinicalTrials.gov)
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Diagnostic Yield of EUS-FNB and EUS-FNA [1 year]. Number, percentage of patients. Fine Needle Aspiration (n=70): 67.1; Fine Needle Biopsy (n=70): 90.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB [1 year]. Number, percentage of participants. Fine Needle Aspiration (n=70): 60.0; Fine Needle Biopsy (n=70): 82.8.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%) [1 yr]. Number, percentage of participants. Fine Needle Aspiration to Fine Needle Biopsy (n=28): 96.4; Fine Needle Biopsy to Fine Needle Aspiration (n=12): 41.7.