- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01494077
Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for Carcinoembryonic Antigen (CEA) Measurement
Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for CEA Measurement
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Potential subjects will be identified based on the indication of a pancreatic cyst requiring EUS-FNA. The procedure will be performed as usual per standard protocol with EUS-FNA of the cyst. Once the fluid is aspirated, it will be measured and if the fluid volume is 2.25 mL or greater than the patient will be included in the study.
A micropipette will be used to ensure exact volumes are measured. The first 1 mL of cystic fluid will be sent to the lab for regular CEA analysis, per standard protocol. The remaining fluid, which would usually be discarded, will then be used for the study. The micropipette will be used to mix 0.75 mL of cyst fluid with 0.25 mL of normal saline (designated sample #2). Next, 0.5 mL of cyst fluid will be mixed with 0.5 mL of normal saline for the next study sample (designated sample #3). These two study samples will be sent to the lab separately using de-identified information, and these values will not be part of the patient's medical record and will not affect clinical management or decision-making. The study samples will be given a unique identifier that will not have any patient identification. The unique identifier will allow the study researchers to link the values to the correct patient by using a password protected program that cannot be accessed by the public.
This study will not require any additional patient participation, and will not impact the length of the procedure. The only additional time will be from the study researchers and the EUS technologists diluting the samples, which will not affect the procedure time itself. If a single patient has more than one cyst, each cyst can be included in the study separately. No additional photographs, videos or data other than the standard data for the procedure will be produced.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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California
-
Orange, California, Forente stater, 92868
- H. H. Chao Comprehensive Digestive Disease Center
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients scheduled for EUS-FNA of a pancreatic cyst
- Cyst must yield 2.25ml (or greater) of fluid
Exclusion Criteria:
- Cysts yielding less than 2.25ml of fluid
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
EUS-FNA of Pancreatic Cyst
Patients who have a pancreatic cyst requiring standard of care EUS-FNA that yields 2.25 ML (or greater) of fluid will be included in the study.
|
There is no intervention.
Extra fluid that is normally discarded will be processed.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of diluted CEA level
Tidsramme: Pancreatic fluid is aspirated once during the procedure.
|
The primary aim of this study is to determine if pancreatic cyst fluid can be diluted and provide an accurate CEA level.
|
Pancreatic fluid is aspirated once during the procedure.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kenneth J. Chang, MD, University of California, Irvine
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 (Anslag)
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
- HS#2011-8161
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