NCT05565066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

7.8 years

First QC Date

September 26, 2022

Last Update Submit

November 26, 2022

Conditions

Neuroendocrine TumorsAutoimmune PancreatitisGastrointestinal Stromal Tumors

Keywords

Endoscopic ultrasoundPathological diagnosisFine needle aspirationFine needle biopsy

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Quality of histologic specimen

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

  • Quality of histologic specimen

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

Study Arms (2)

FNB group

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

Device: FNB group

FNA group

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

Device: FNA group

Interventions

FNB groupDEVICE

Fine-needle-biopsy (Echotip ProCore Needle)

FNB group
FNA groupDEVICE

Fine-needle-aspiration (Echotip Needle)

FNA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Neuroendocrine TumorsAutoimmune PancreatitisGastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissuePancreatitis, ChronicPancreatitisPancreatic DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueGastrointestinal NeoplasmsDigestive System NeoplasmsGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 4, 2022

Study Start

December 1, 2014

Primary Completion

September 30, 2022

Study Completion

October 31, 2022

Last Updated

December 1, 2022

Record last verified: 2022-11

Locations

CN(1)