- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02865382
Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy
Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy: A Randomized Trial
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Colorectal cancer is the third most common cancer in the world.Colonoscopy is the gold standard screening test for colorectal cancer.There are also emerging data to support that screening by colonoscopy reduces both the incidence and mortality of colorectal cancer.However,Colonoscopy could still miss colorectal adenomas and even cancer.The miss rate for colonic adenomas was reported to be ranging from 15 to 32% in tandem colonoscopy studies.The reasons for the miss rate may be technical(insufficient during excessively fast instrument withdrawal),but may also be the imaging method.Smaller lesions ,particularly flat ones ,may be missed as a result of their subtle appearance and limited contrast in relation to the surrounding mucosa.
Some image-enhanced modules were developed with an aim to improve colorectal polyp or adenoma detection.The widely available modules is the narrow band imaging(NBI).However,most studies failed to demonstrate any superiority of NBI system over white light colonoscopy in detecting colonic polyps.NBI provides dimmer images of the colonic mucosa ,which may limit its performance on polyp and adenoma detection.
Like NBI,OE technology is image-enhanced module,providing a more intense look at the vascular pattern morphology.Besides,OE technology provides an much brighter image compared to NBI.This may possibly increase polyp detection by enhancing visibility of the colonic mucosa with brighter image.The current study aims to tested whether OE technology would improve adenoma detection when compared with high-definition colonoscopy.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Shandong
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Jinan, Shandong, Kina, 250012
- Department of Gastroenterology, Qilu Hospital, Shandong University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients were selected if they presented for diagnostic colonoscopy for a variety of indications(eg positive fecal occult blood test, abdominal pain, diarrhoea,post-polypectomy surveillance).
Exclusion Criteria:
- Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
- The cecum could not be intubated.
- Inadequate bowel preparation (Aronchick Bowel Preparation Scale score poor or inadequate).
- Biopsies were not available.
- Unable to provide informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Group A
white light was used for both insertion and withdrawal of the colonoscope
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Eksperimentel: Group B
Insertion to cecum was performed under white light and once the cecum was reached,the OE mode was swithed on during withdrawal of endoscope for complete colonic examination
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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adenoma detection rate
Tidsramme: 6 months
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Yanqing Li, MD, PhD, Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
Publikationer og nyttige links
Generelle publikationer
- Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
- Aminalai A, Rosch T, Aschenbeck J, Mayr M, Drossel R, Schroder A, Scheel M, Treytnar D, Gauger U, Stange G, Simon F, Adler A. Live image processing does not increase adenoma detection rate during colonoscopy: a randomized comparison between FICE and conventional imaging (Berlin Colonoscopy Project 5, BECOP-5). Am J Gastroenterol. 2010 Nov;105(11):2383-8. doi: 10.1038/ajg.2010.273. Epub 2010 Jul 13.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016SDU-QILU-11
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Kliniske forsøg med Colonpolypper
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University of ManitobaAktiv, ikke rekrutterendePolypper | Colon polyp | Polyp af tyktarm | Colo-rektal cancer | Colon polyp | Rektal polyp | Polyp rektalCanada
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Vejle HospitalIkke rekrutterer endnuKolorektal cancer | Colon polyp | Kolorektal polyp | Fælles beslutningstagning | Beslutningshjælpemidler | Rektal polyp
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University College, LondonIkke rekrutterer endnuPolypper | Colon polyp | Adenom tyktarm | Kolorektal polyp | Polypper af tyktarmDet Forenede Kongerige
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Medical University of ViennaAfsluttetFlere polypper højre kolon | Stor polyp højre kolon | Mistænkt polyp højre kolonØstrig
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South Tyneside and Sunderland NHS Foundation TrustMedtronic; Newcastle University; North Wales Organisation for Randomised...AfsluttetColon polyp | Kolorektalt adenom | Kolorektal polyp | Kolorektal SSA | Kolorektal adenomatøs polyp | Sessilt takket adenom | Fastsiddende tyktarmspolypDet Forenede Kongerige
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Nanfang Hospital of Southern Medical UniversityUkendt
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Region SkaneCarponovum ABAfsluttetKræft | PolypSverige
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University Hospital, GhentRekruttering
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Region SkaneTrukket tilbageKolorektal polypSverige
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Instituto Ecuatoriano de Enfermedades DigestivasAfsluttet