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2014-12-01
2022-09-30
2022-10-31
439
NCT05565066
Huazhong University of Science and Technology
Huazhong University of Science and Technology
OBSERVATIONAL
A Real-world Comparison of FNB and FNA in IHC-required Lesions.
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-09-26 | N/A | 2022-11-26 |
2022-09-29 | N/A | 2022-12-01 |
2022-10-04 | N/A | 2022-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : FNB group FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings. | DEVICE: FNB group
|
| : FNA group FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings. | DEVICE: FNA group
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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