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

November 26, 2022 updated by: Bin Cheng, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

439

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, HUST

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
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
Time Frame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
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
Time Frame: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
dignostic yields of GIST
From admission until the date of pathological diagnosis obtained or follow-up up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks
Quality of histologic specimen
Time Frame: From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks
Specimen adequacy - tissue intergrity
From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

Peking Union Medical College

Study record dates

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 Major Dates

Study Start (ACTUAL)

December 1, 2014

Primary Completion (ACTUAL)

September 30, 2022

Study Completion (ACTUAL)

October 31, 2022

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (ACTUAL)

October 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 26, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNB-2022tj

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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