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

Neuroendocrine Tumors Clinical Trial

Official title:

A Real-world Comparison of FNB and FNA in IHC-required Lesions: A Prospective, Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05565066
• Other study ID #: FNB-2022tj
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Autoimmune Pancreatitis
• Gastrointestinal Stromal Tumors
• Neuroendocrine Tumors
• Pancreatitis

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