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

Completed

• Conditions: Neuroendocrine Tumors; Gastrointestinal Stromal Tumors; Autoimmune Pancreatitis
• Interventions: Device: FNB group; Device: FNA group

• Registration Number: NCT05565066
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-29
• Primary Completion: 2022-09-30
• Study First Posted: 2022-10-04
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-26
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FNB group	FNB group	FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings.
FNA group	FNA group	FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings.

Primary Outcome Measures

Name	Time	Method
Diagnostic yields of EUS-FNA with EUS-FNB for solid masses	From admission until the date of pathological diagnosis obtained or follow-up up to 24 months	dignostic yields of GIST

Secondary Outcome Measures

Name	Time	Method
Quality of histologic specimen	From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks	Specimen adequacy - tissue intergrity

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, HUST; 🇨🇳 Wuhan, Hubei, China