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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05565066
Other study ID # FNB-2022tj
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2014
Est. completion date October 31, 2022

Study information

Verified date November 2022
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 439
Est. completion date October 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
FNB group
Fine-needle-biopsy (Echotip ProCore Needle)
FNA group
Fine-needle-aspiration (Echotip Needle)

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, HUST Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Huazhong University of Science and Technology Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary Quality of histologic specimen Specimen adequacy - tissue intergrity From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks
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