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

Huazhong University of Science and Technology

Status

Completed

Conditions

Autoimmune Pancreatitis

Gastrointestinal Stromal Tumors

Neuroendocrine Tumors

Treatments

Device: FNB group

Device: FNA group

Study type

Observational

Funder types

Other

Identifiers

NCT05565066

FNB-2022tj

Details and patient eligibility

About

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.

Full description

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.

Enrollment

439 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.