Detect InSpect ChAracterise Resect and Discard 2 (DISCARD2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01603927|
Recruitment Status : Unknown
Verified May 2012 by South Tyneside NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : May 23, 2012
Last Update Posted : May 23, 2012
Bowel cancer is a common disorder in the UK. Most cancers happen when a type of polyp, called an adenoma, becomes cancerous. Polyps are growths in the large bowel that can be cancerous, non-cancerous, or pre-cancerous (adenoma). Polyps are most commonly detected during colonoscopy (camera test of the lower bowel). The removal of adenomas has been shown to reduce the subsequent risk of bowel cancer. Current practice is that all polyps are removed or biopsied to allow a laboratory diagnosis (histology). This is important as it influences if and when patients require follow-up colonoscopies, known as the surveillance interval. Patients with only non-cancerous polyps do not need surveillance.
A new blue light technology, called narrow band imaging (NBI), used during colonoscopy can help colonoscopists (doctor or nurse performing the procedure)differentiate between polyp types during colonoscopy. NBI is currently available in a large number of UK endoscopy units however is variably used. Studies from 'expert' centres have demonstrated that NBI allows accurate optical diagnosis of colonic polyps. Benefits of optical diagnosis include avoiding removal of non-cancerous polyps and an immediate (on the day) diagnosis for the patient including the surveillance interval.
The primary aim of this study is to evaluate the accuracy with which colonoscopists assess the required surveillance interval using optical diagnosis when compared with histology in non-expert centres. The investigators will invite 2500 patients, who have been referred for colonoscopy, to participate. Patients will undergo a routine colonoscopy the only addition being the use of NBI during the procedure. Colonoscopists will provide an optical diagnosis at the time of colonoscopy in addition to polyp removal or biopsy.
The investigators will compare surveillance intervals provided using optical diagnosis with the diagnosis from histology and thereby the accuracy with which colonoscopists can use the technology. The investigators will also calculate the cost savings to the NHS.
|Condition or disease||Intervention/treatment|
|Colonic Polyps||Device: Narrow band imaging for 'optical diagnosis' of colonic polyps (Olympus).|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Official Title:||Detect InSpect ChAracterise Resect and Discard 2|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2013|
Colonoscopy with Narrow band imaging (NBI)
All patients attending for routine colonoscopies performed for the diagnosis of symptoms or asymptomatic screening.
Device: Narrow band imaging for 'optical diagnosis' of colonic polyps (Olympus).
Colonoscopists will narrow band imaging to provide an 'optical diagnosis' for colonic polyps found during routine colonoscopies performed for the diagnosis of symptoms or asymptomatic screening.
- The sensitivity NBI optical diagnosis in determining colonoscopy surveillance intervals. [ Time Frame: 12 months ]The proportion of individuals requiring surveillance colonoscopy (according to British Society of Gastroenterology Guidelines)that are correctly identified by NBI optical diagnosis (test sensitivity).
- The sensitivity, specificity and accuracy of optical diagnosis on a per polyp basis. [ Time Frame: 12 months ]Sensitivity, specificity and accuracy of optical diagnosis on a per-polyp basis
- The learning curve and maintenance of accuracy of optical diagnosis. [ Time Frame: 12 months ]Learning curve and maintenance of quality of optical diagnosis measured by proportion of polyps/patients diagnosed with high/low confidence.
- The economic implications of replacing histological assessment with optical diagnosis. [ Time Frame: 12 months ]Potential cost saving of optical diagnosis
- Description of the population undergoing routine colonoscopy and prevalence of polyps and polyp type. [ Time Frame: 12 months ]Proportion of patients with no polyps, small polyps, large polyps, categorised by age, gender and polyps type.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603927
|Contact: Colin J Rees, MBBS, FRCP||(0191) 4041000 ext firstname.lastname@example.org|
|Contact: Praveen T Rajasekhar, MBChB BMedSci MRCP||(0191) 4041000 ext email@example.com|
|County Durham and Darlington NHS Foundation Trust||Not yet recruiting|
|Darlington, County Durham, United Kingdom, DL3 6HX|
|Contact: John G Silcock, MBBS, FRCP firstname.lastname@example.org|
|Principal Investigator: John G Silcock, MBBS, FRCP|
|North Cumbria University Hospitals NHS Trust||Not yet recruiting|
|Carlisle, Cumbria, United Kingdom, CA2 7HY|
|Contact: Chris E MacDonald, MBBS FRCP 01228 814184 email@example.com|
|Principal Investigator: Chris E MacDonald, MBBS FRCP|
|Northumbria Healthcare NHS Trust||Not yet recruiting|
|Ashington, Northumberland, United Kingdom, NE63 9JJ|
|Contact: Anthoor Jayaprakash firstname.lastname@example.org|
|Principal Investigator: Anthoor Jayaprakash|
|South Tees NHS Trust||Not yet recruiting|
|Middlesbrough, Teeside, United Kingdom, TS4 3BW|
|Contact: Arvind Ramadas, MBBS, MRCP email@example.com|
|Principal Investigator: Arvind Ramadas, MBBS, MRCP|
|North Tees and Hartlepool NHS Foundation Trust||Not yet recruiting|
|Stockton-on-Tees, Teeside, United Kingdom, TS19 8PE|
|Contact: Matthew D Rutter, MBChB MD +44(0)1642 624557 firstname.lastname@example.org|
|Principal Investigator: Matthew D Rutter, MBChB MD|