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NBI With Magnification for Dysplasia Detection in Ulcerative Colitis

21. september 2007 opdateret af: London North West Healthcare NHS Trust

Randomised,Controlled Trial of Narrow Band Imaging With Magnification (NBI) Versus White Light Endoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance

The purpose of the study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI) helps doctors detect more patients with at leat one pre-cancerous area (dysplasia associated lession or mass, MALMs) than conventional colonoscopy using white light alone.

Studieoversigt

Status

Ukendt

Betingelser

Colitis ulcerosa

Intervention / Behandling

Detaljeret beskrivelse

Colorectal cancer is the second commonest cause of cancer death. Patients with colitis have a substantially increased risk of death from colorectal cancer which increases with lenght of time the patient has had colitis. This can be as high as a 30% chance of colorectal cancer after 30 years of colitis. Colonoscopic surveillance of colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed.

Precancerous lesions in colitis are difficult to see and endoscopist have used spraying dye on the lining of the bowel (chromoendoscopy) successfully to improve detection of abnormal areas: however this is time consuming and requires extra time and equipment and despite the benefits seen in multiple studies is not widely used in routine clinical practice in the UK.

Narrow band imaging (NBI) is a technique that relies on light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. With magnification it allows assessment of the fine mucosal surface pattern (pit pattern) of lesion which allows and assessment of their likelihood of being precancerous. Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.

We aim to see if NBI with magnification is better that standard colonoscopy for detecting precancerous areas. This is likely as it produces images similar to chromoendoscopy which is already shown to help. If a potentially precancerous area is found we will use other types of endoscopy, particularly NBI autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous areas

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

110

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Det Forenede Kongerige
- - Nottingham, Det Forenede Kongerige, NG7 2UH
    - Rekruttering
    - Nottingham Univesrity Hospitals NHS Trust, Queen's Medical Centre
    - Kontakt:
      
      Krish Ragunath, Dr
    - Ledende efterforsker:
      
      Krish Ragunath, Dr
- Middlesex
  - London, Middlesex, Det Forenede Kongerige, HA1 3UJ
    - Rekruttering
    - North West London Hospitals NHS Trust - St Mark's
    - Kontakt:
      
      Alan Warnes, PhD
      
      Telefonnummer: 2011 0044208 869
      
      E-mail: alan.warnes@nwlh.nhs.uk
    - Kontakt:
      
      Iva Hauptmannova, BSc MA
      
      Telefonnummer: 5286 0044208 869
      
      E-mail: iva.hauptmannova@nwlh.nhs.uk
    - Ledende efterforsker:
      
      Brian Saunders, MD FRCP

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

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

petients with colitis who meet surveillance criteria
patients over 18 years of age

Exclusion Criteria:

pregnant patients
unable or unwilling to give informed consent
patients with severe active colitis who would be unsafe to endoscope

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: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Effectiveness of NBI versus Light endoscopy

Sekundære resultatmål

Resultatmål
Are more precancerous lessions found in total with NBI?
Are more advanced precancerous lesions found with NBI?
Are more patients found with more that one precancerous lesion with NBI?
How Many lessions are successfully completely removed via the endoscope?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

London North West Healthcare NHS Trust

Samarbejdspartnere

Nottingham University Hospitals NHS Trust

Efterforskere

Ledende efterforsker: Brian Saunders, MD, FRCP, London North West Healthcare NHS Trust

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. februar 2006

Datoer for studieregistrering

Først indsendt

14. februar 2006

Først indsendt, der opfyldte QC-kriterier