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

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT05565066

Collaborator

Peking Union Medical College (Other)

439

Enrollment

Location

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors Autoimmune Pancreatitis Gastrointestinal Stromal Tumors	Device: FNB group Device: FNA group

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 Design

Study Type:

Observational

Actual Enrollment :

439 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
FNB group FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings.	Device: FNB group Fine-needle-biopsy (Echotip ProCore Needle)
FNA group FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings.	Device: FNA group Fine-needle-aspiration (Echotip Needle)

Arm

Intervention/Treatment

FNB group

FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings.

Device: FNB group

Fine-needle-biopsy (Echotip ProCore Needle)

FNA group

FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings.

Device: FNA group

Fine-needle-aspiration (Echotip Needle)

Outcome Measures

Primary Outcome Measures

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]
Overall dignostic yields of all solid lesions
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 AIP
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 NET
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

Quality of histologic specimen [From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks]
Specimen adequacy - whether adequate for IHC staining
Quality of histologic specimen [From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks]
Specimen adequacy - tissue intergrity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.