Neuroendocrine TumorsNCT05565066
A Real-world Comparison of FNB and FNA in IHC-required Lesions.
An observational study of Neuroendocrine Tumors and Autoimmune Pancreatitis, run by Huazhong University of Science and Technology at 1 site in China.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Autoimmune Pancreatitis, Gastrointestinal Stromal Tumors
- What is being tested?
- FNB group and FNA group
- Type of treatment
- Medical device
- How many people
- 439 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2014to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- FNB group, FNA group
- Keywords
- Endoscopic ultrasound, Pathological diagnosis, Fine needle aspiration, Fine needle biopsy
- Medical subject headings
- Neuroendocrine Tumors, Autoimmune Pancreatitis, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNB groupDevice
Fine-needle-biopsy (Echotip ProCore Needle)
FNA groupDevice
Fine-needle-aspiration (Echotip Needle)
| Study group | Role | What they receive |
|---|---|---|
| FNB group | FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings. Receives: Device: FNB group | |
| FNA group | FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings. Receives: Device: FNA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yields of EUS-FNA with EUS-FNB for solid masses
Overall dignostic yields of all solid lesions
Measured: 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
dignostic yields of AIP
Measured: 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
dignostic yields of NET
Measured: 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
dignostic yields of GIST
Measured: From admission until the date of pathological diagnosis obtained or follow-up up to 24 months
Secondary outcomes (2)
Quality of histologic specimen
Specimen adequacy - whether adequate for IHC staining
Measured: From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks
Quality of histologic specimen
Specimen adequacy - tissue intergrity
Measured: From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Dec 2014
- Primary completion30 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College
- Responsible party
- Principal investigator, Bin Cheng, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565066
- Sponsor's protocol ID
- FNB-2022tj
- Status last verified
- Nov 2022
- First submitted
- 26 Sep 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Comparison of FNB and FNA in IHC-required Lesions: A Prospective, Multicenter Study.
- ClinicalTrials.gov ID
- NCT05565066
- Acronym / sponsor ID
- FNB-2022tj
- Keywords
- Endoscopic ultrasound, Pathological diagnosis, Fine needle aspiration, Fine needle biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Peking Union Medical College
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNB group | – | Device: FNB groupFNB needles adpted to acquire lesion tissues according patients' advice and patients' willings. |
| FNA group | – | Device: FNA groupFNA needles adpted to acquire lesion tissues according patients' advice and patients' willings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNB groupFine-needle-biopsy (Echotip ProCore Needle) | Device | FNB group |
| FNA groupFine-needle-aspiration (Echotip Needle) | Device | FNA group |
Primary outcome
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
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
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
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
2 secondary outcomes
Quality of histologic specimen
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Autoimmune Pancreatitis, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.