Clinical trial NCT05565066: A Real-world Comparison of FNB and FNA in IHC-required Lesions.
Official title: A Real-world Comparison of FNB and FNA in IHC-required Lesions: A Prospective, Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Autoimmune Pancreatitis
Gastrointestinal Stromal Tumors
Keywords: Endoscopic ultrasound
Pathological diagnosis
Fine needle aspiration
Fine needle biopsy
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
First posted: 2022-10-04
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic yields of EUS-FNA with EUS-FNB for solid masses
timeFrame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
measure: Diagnostic yields of EUS-FNA with EUS-FNB for solid masses
timeFrame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
measure: Diagnostic yields of EUS-FNA with EUS-FNB for solid masses
timeFrame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
measure: Diagnostic yields of EUS-FNA with EUS-FNB for solid masses
timeFrame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
Secondary outcomes:
measure: Quality of histologic specimen
timeFrame: From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks
measure: Quality of histologic specimen
timeFrame: From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, HUST
state: Hubei
Study officials:
References: