NBI With Magnification for Dysplasia Detection in Ulcerative Colitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by North West London Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nottingham University Hospitals NHS Trust
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00292175
First received: February 14, 2006
Last updated: September 21, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Procedure: Narrow Band Imaging
Procedure: colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomised,Controlled Trial of Narrow Band Imaging With Magnification (NBI) Versus White Light Endoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

Primary Outcome Measures:
  • Effectiveness of NBI versus Light endoscopy

Secondary Outcome Measures:
  • 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?

Estimated Enrollment: 110
Study Start Date: February 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292175

Contacts
Contact: Brian Saunders, MD, FRCP 0044208235 ext 4227 b.saunders@imperial.ac.uk
Contact: James East, BSc, MBChB, MRCP 0044208235 ext 4025 jameseast@yahoo.com

Locations
United Kingdom
North West London Hospitals NHS Trust - St Mark's Recruiting
London, Middlesex, United Kingdom, HA1 3UJ
Contact: Alan Warnes, PhD    0044208 869 ext 2011    alan.warnes@nwlh.nhs.uk   
Contact: Iva Hauptmannova, BSc MA    0044208 869 ext 5286    iva.hauptmannova@nwlh.nhs.uk   
Principal Investigator: Brian Saunders, MD FRCP         
Nottingham Univesrity Hospitals NHS Trust, Queen's Medical Centre Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Krish Ragunath, Dr         
Principal Investigator: Krish Ragunath, Dr         
Sponsors and Collaborators
North West London Hospitals NHS Trust
Nottingham University Hospitals NHS Trust
Investigators
Principal Investigator: Brian Saunders, MD, FRCP North West London Hospitals NHS Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00292175     History of Changes
Other Study ID Numbers: 06/NBI2/10
Study First Received: February 14, 2006
Last Updated: September 21, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by North West London Hospitals NHS Trust:
colonoscopy, narrow band imaging (NBI), ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014