Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study (NBI)
31. oktober 2017 opdateret af: Roy Soetikno, VA Palo Alto Health Care System
Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study
We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Interval colorectal cancers diagnosed within a three year period following a clearing colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy.
Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or detection rates using narrow band imaging as compared to colonoscopy using white light.
However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis and should be furthered studied, especially considering that they are thought to be a strong contributor to a false negative colonoscopy.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
281
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Palo Alto, California, Forenede Stater, 94304
- Veterans Affairs Palo Alto
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San Francisco, California, Forenede Stater, 94121
- Veterans Affairs San Francisco
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Missouri
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Kansas City, Missouri, Forenede Stater, 64128
- Veterans Affairs Kansas City
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients referred for routine colonoscopy are eligible
Exclusion Criteria:
- Known Inflammatory bowel disease
- Referred for endoscopic evaluation and removal of colorectal lesion
- Personal or family history of polyposis or non-polyposis syndrome
- Presentation for emergency endoscopy
- Inability to remove polyp due to coagulopathy or thrombocytopenia
- Inability to provide informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: High Definition NBI Colonoscopy
Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
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Technically improved colonoscope with close focus high definition narrow band imaging.
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Placebo komparator: High Definition White Light Colonoscopy
Use of high definition white light colonoscopy during examination for polyp detection.
The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
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Technically improved colonoscope with close focus high definition narrow band imaging.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
Tidsramme: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
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Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
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One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Missed Lesions on Index Colonoscopy.
Tidsramme: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
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Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.
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One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
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Percentage of Nonpolypoid (Flat) Missed Lesions
Tidsramme: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
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Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.
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One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tonya Kaltenbach, MD MS, San Francisco Veterans Affairs Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Soetikno RM, Kaltenbach T, Rouse RV, Park W, Maheshwari A, Sato T, Matsui S, Friedland S. Prevalence of nonpolypoid (flat and depressed) colorectal neoplasms in asymptomatic and symptomatic adults. JAMA. 2008 Mar 5;299(9):1027-35. doi: 10.1001/jama.299.9.1027.
- Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.
- Kaltenbach T, Soetikno R. Image-enhanced endoscopy is critical in the detection, diagnosis, and treatment of non-polypoid colorectal neoplasms. Gastrointest Endosc Clin N Am. 2010 Jul;20(3):471-85. doi: 10.1016/j.giec.2010.04.001.
- Rex DK, Bond JH, Feld AD. Medical-legal risks of incident cancers after clearing colonoscopy. Am J Gastroenterol. 2001 Apr;96(4):952-7. doi: 10.1111/j.1572-0241.2001.03677.x.
- Rex DK, Helbig CC. High yields of small and flat adenomas with high-definition colonoscopes using either white light or narrow band imaging. Gastroenterology. 2007 Jul;133(1):42-7. doi: 10.1053/j.gastro.2007.04.029. Epub 2007 Apr 20.
- van den Broek FJ, Reitsma JB, Curvers WL, Fockens P, Dekker E. Systematic review of narrow-band imaging for the detection and differentiation of neoplastic and nonneoplastic lesions in the colon (with videos). Gastrointest Endosc. 2009 Jan;69(1):124-35. doi: 10.1016/j.gie.2008.09.040. No abstract available.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2013
Primær færdiggørelse (Faktiske)
1. maj 2016
Studieafslutning (Faktiske)
1. august 2016
Datoer for studieregistrering
Først indsendt
7. marts 2011
Først indsendt, der opfyldte QC-kriterier
7. marts 2011
Først opslået (Skøn)
8. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. december 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Patologiske Tilstande, Anatomiske
- Intestinale neoplasmer
- Endetarmssygdomme
- Tarmpolypper
- Kolorektale neoplasmer
- Polypper
- Colonpolypper
Andre undersøgelses-id-numre
- FIND FLAT PA19624
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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