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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

439 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2022-10-31

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.

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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.

Conditions

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Neuroendocrine Tumors Autoimmune Pancreatitis Gastrointestinal Stromal Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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FNB group

FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings.

FNB group

Intervention Type DEVICE

Fine-needle-biopsy (Echotip ProCore Needle)

FNA group

FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings.

FNA group

Intervention Type DEVICE

Fine-needle-aspiration (Echotip Needle)

Interventions

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FNB group

Fine-needle-biopsy (Echotip ProCore Needle)

Intervention Type DEVICE

FNA group

Fine-needle-aspiration (Echotip Needle)

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No