Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle (MUCIN)
Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.
The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.
We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90095
- UCLA Medical Center
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San Francisco, California, Forente stater, 94117
- California Pacific Medical Center
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Florida
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Tampa, Florida, Forente stater, 33612
- Moffit Cancer center
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent
Exclusion Criteria:
- 3.2.1 Coagulopathy which is not corrected
3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Fine needle aspiration
fine needle aspiration
|
Fine needle aspiration
Andre navn:
FNB
Andre navn:
|
|
Aktiv komparator: Fine needle biopsy
|
Fine needle aspiration
Andre navn:
FNB
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic Yield of EUS-FNB and EUS-FNA
Tidsramme: 1 year
|
The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled.
This will be expressed as a percentage.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB
Tidsramme: 1 year
|
The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist.
This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question.
This will be expressed as a percentage and compared between FNA and FNB
|
1 year
|
|
Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)
Tidsramme: 1 yr
|
As above.
Crossover to FNA or FNB occurs after 3 passes without adequate material
|
1 yr
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Srinadh Komanduri, Northwestern University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FNAFNBmucin
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