- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00279357
Randomised Trial of NBI for Adenoma Detection
Randomised, Controlled Trial of Narrow Band Imaging (NBI) Versus Standard Endoscopy for Adenoma Detection
Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors detect more patients with at least one pre-cancerous polyp (adenoma) than conventional colonoscopy using white light alone?
May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce the death rate from colorectal cancer. However, despite meticulous examination there is a "miss rate" for adenomas at colonoscopy which ranges from 66-25% in back-to-back colonoscopy studies. The nature of the polyps which as well as being pedunculated (cherry like) can be flat or depressed making them difficult to see, which may contribute to the "miss rate".
The factors, which influence the endoscopist detection are not well studied. Polyp detection rates wary widely, even among experts. Techniques that highlight lesions have advanced in recent years. Chromoendoscopy, the current gold standard technique, relies on spraying dye on the bowel lining, has been shown to help pick up more pre-cancerous polyps in two of three studies; however it is not widely used as it is time consuming and requires extra equipment and training. Narrow band imaging (NBI) is a technique that relies in light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up adenomas 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. 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 is better than standard colonoscopy for detecting precancerous polyps. This is likely as it is similar to chromoendoscopy which is already shown to help. If a polyp is found we will use other types of endoscopy, particularly NBI with magnification and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous polyps.
May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability. No additional data collected.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Brian Saunders, MD FRCP
- E-mail: b.saunders@imperial.ac.uk
Sauvegarde des contacts de l'étude
- Nom: James East, MBChB MRCP
- E-mail: jameseast@yahoo.com
Lieux d'étude
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London, Royaume-Uni, HA1 3UJ
- Recrutement
- North West London Hospitals NHS Trust - St Mark's
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Contact:
- Alan Warnes, PhD
- E-mail: alan.warnes@nwlh.nhs.uk
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Chercheur principal:
- Brian Saunders, MD FRCP
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Contact:
- Iva Hauptmannova, BSc MA
- E-mail: iva.hauptmannova@nwlh.nhs.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients over 18 years of age, patients in a high risk group for adenomas
Exclusion Criteria:
- patients with known colitis or polyposis, unable or unwilling to give informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Difference in number of patients with at least one histologically demonstrated adenoma between the two groups
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Mesures de résultats secondaires
Mesure des résultats |
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Number of adenomas detected in each arm
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number of advance adenomas (>20% villous elements, >10mm, high grade dysplasia) detected in each arm
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Total number of flat adenomas detected in each arm
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total number of non-neoplastic lesion in each arm
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total number of patients with 3 or more adenomas detected in each arm
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total number of patients with 5 or more adenomas detected in each arm
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assessment of video still for detection of neo-plastic or non-plastic nature of polyps, AFI, vs NBI vs NBI with magnification versus white light
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Sub-group analysis of primary end point according to indication for colonoscopy
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Brian Saunders, MD FRCP, London North West Healthcare NHS Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 05/NBI/121
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