A Real-world Comparison of FNB and FNA in IHC-required Lesions.

Study Overview
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Brief Summary
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Endoscopic ultrasound (EUS)-guided fine needles with side fenestrations are used to collect aspirates for cytology analysis and biopsy samples for histologic analysis. The investigators conducted a large, multicenter study to compare the accuracy of diagnosis via specimens collected with fine-needle biopsy (FNB) versus fine-needle aspiration (FNA) for patients with lesions requiring immunohistochemistry (IHC) pathological diagnosis.

Detailed Description
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Current guidelines recommend FNA and FNB needles equally for pancreatic and other deep-seated lesions. However, some studies indicate that the sample adequacy for histologic evaluation is higher when using FNB compared with FNA needles. The diagnosis of neuroendocrine tumor (NET), autoimmune pancreatitis (AIP), and other gastrointestinal stromal tumors require high-quality tissue sampling for IHC diagnosis. Whether FNB is superior to FNA in these IHC-required lesions remains unclear. The investigators performed this at 2 tertiary care centers in China. The study prospectively collected patients undergoing EUS for a solid mass (>1 cm) in the pancreas, abdomen, mediastinum, or pelvic cavity from December 2014 diagnosed with AIP, NET, mesenchymal tumors, and Lymphoma. Patients accepted FNB or FNA according to doctors' and patients' willingness in a real-world setting. All procedures were performed by experienced endosonographers; cytologists and pathologists were blinded to the sample collection method. Patients were followed for at least 48 weeks, and final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion. The primary aim was to compare diagnostic yields of EUS-FNA with EUS-FNB for all solid masses, then separately as AIP, NET, mesenchymal tumors, and lymphoma. The secondary endpoint was the quality of the histologic specimen.

Official Title
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A Real-world Comparison of FNB and FNA in IHC-required Lesions: A Prospective, Multicenter Study.

Conditions
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Neuroendocrine Tumors, Autoimmune Pancreatitis, Gastrointestinal Stromal Tumors

Intervention / Treatment
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* Device: FNB group
* Device: FNA group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years; presence of a solid mass lesion was confirmed by at least 1 imaging modality and it was located within pancreas, abdomen, mediastinum, or pelvic cavity; mass size >1 cm; final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion, including AIP, NET, mesenchymal tumors, and lymphoma. Exclusion Criteria: coagulopathy (international normalized ratio, 1.5); thrombocytopenia (platelet count <50,000/mm3); acute pancreatitis within the previous 2 weeks; inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FNB group<br>FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings. | Device: FNB group<br>* Fine-needle-biopsy (Echotip ProCore Needle)<br>|
| FNA group<br>FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings. | Device: FNA group<br>* Fine-needle-aspiration (Echotip Needle)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yields of EUS-FNA with EUS-FNB for solid masses | Overall dignostic yields of all solid lesions | From admission until the date of pathological diagnosis obtained or follow-up up to 24 months | 
| Diagnostic yields of EUS-FNA with EUS-FNB for solid masses | dignostic yields of AIP | From admission until the date of pathological diagnosis obtained or follow-up up to 24 months | 
| Diagnostic yields of EUS-FNA with EUS-FNB for solid masses | dignostic yields of NET | From admission until the date of pathological diagnosis obtained or follow-up up to 24 months | 
| Diagnostic yields of EUS-FNA with EUS-FNB for solid masses | dignostic yields of GIST | From admission until the date of pathological diagnosis obtained or follow-up up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of histologic specimen | Specimen adequacy - whether adequate for IHC staining | From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks | 
| Quality of histologic specimen | Specimen adequacy - tissue intergrity | From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic ultrasound, Pathological diagnosis, Fine needle aspiration, Fine needle biopsy