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NCT Number: NCT05565066

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.

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Key information

Conditions

Neuroendocrine Tumors Autoimmune Diseases Autoimmune Pancreatitis Chronic Disease Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Immune System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FNB group

Device

Fine-needle-biopsy (Echotip ProCore Needle)

FNA group

Device

Fine-needle-aspiration (Echotip Needle)

Primary outcomes

  1. Diagnostic yields of EUS-FNA with EUS-FNB for solid masses

    Time frame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months

    Overall dignostic yields of all solid lesions

  2. Diagnostic yields of EUS-FNA with EUS-FNB for solid masses

    Time frame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months

    dignostic yields of AIP

  3. Diagnostic yields of EUS-FNA with EUS-FNB for solid masses

    Time frame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months

    dignostic yields of NET

  4. Diagnostic yields of EUS-FNA with EUS-FNB for solid masses

    Time frame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months

    dignostic yields of GIST

Secondary outcomes

  1. Quality of histologic specimen

    Time frame: From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks

    Specimen adequacy - whether adequate for IHC staining

  2. Quality of histologic specimen

    Time frame: From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks

    Specimen adequacy - tissue intergrity

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Peking Union Medical College

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2022
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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