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Detect InSpect ChAracterise Resect and Discard 2 (DISCARD2)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by South Tyneside NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603927
First Posted: May 23, 2012
Last Update Posted: May 23, 2012
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.
Collaborator:
University of Durham
Information provided by (Responsible Party):
South Tyneside NHS Foundation Trust
  Purpose

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 Intervention
Colonic Polyps Device: Narrow band imaging for 'optical diagnosis' of colonic polyps (Olympus).

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detect InSpect ChAracterise Resect and Discard 2

Resource links provided by NLM:


Further study details as provided by South Tyneside NHS Foundation Trust:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 2500
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients attending for routine diagnostic or screening colonoscopy.
Criteria

Inclusion Criteria:

Phase 1

  1. Patients able to provide valid informed consent.
  2. Patients over 18 years of age.
  3. Patients attending for routine colonoscopy.

Phase 2

  1. Patient fulfils inclusion criteria for phase 1.
  2. Patients with one or more polyps under 10mm detected at colonoscopy.
  3. Patients undergoing a complete colonoscopy confirmed by photo documentation of caecal landmarks.

Exclusion Criteria:

  1. Patients with known inflammatory bowel disease (ulcerative colitis of Crohns disease) or known polyposis syndromes.
  2. Patients who lack capacity to give informed consent as assessed by the clinical study team member taking consent.
  3. Patients who are known to be pregnant (self-reported).
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Colin J Rees, MBBS, FRCP (0191) 4041000 ext 4028 colin.rees@stft.nhs.uk
Contact: Praveen T Rajasekhar, MBChB BMedSci MRCP (0191) 4041000 ext 2899 praveen.rajasekhar@nhs.net

Locations
United Kingdom
County Durham and Darlington NHS Foundation Trust Not yet recruiting
Darlington, County Durham, United Kingdom, DL3 6HX
Contact: John G Silcock, MBBS, FRCP       john.silcock@cddft.nhs.uk   
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    chris.macdonald@ncuh.nhs.uk   
Principal Investigator: Chris E MacDonald, MBBS FRCP         
Northumbria Healthcare NHS Trust Not yet recruiting
Ashington, Northumberland, United Kingdom, NE63 9JJ
Contact: Anthoor Jayaprakash       anthoor.jayaprakash@northumbria-healthcare.nhs.uk   
Principal Investigator: Anthoor Jayaprakash         
South Tees NHS Trust Not yet recruiting
Middlesbrough, Teeside, United Kingdom, TS4 3BW
Contact: Arvind Ramadas, MBBS, MRCP       arvind.ramadas@stees.nhs.uk   
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    matt.rutter@nth.nhs.uk   
Principal Investigator: Matthew D Rutter, MBChB MD         
Sponsors and Collaborators
South Tyneside NHS Foundation Trust
University of Durham
  More Information

Publications:
National Bowel Cancer Audit 2009 NBOCAP Available at: http://www.nbocap.org.uk/resources/reports/NBOCAP_2009.pdf
Morson B. President's address. The polyp-cancer sequence in the large bowel. Proc R Soc Med. 1974 Jun;67(6 Pt 1):451-7.
Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81.
Lee TJW, Rutter MD, Blanks, RG et al. Colonoscopy quality measure: experience from the NHS Bowel Cancer Screening Programme. Gut 2011. Available at: http://gut.bmj.com/content/early/2011/09/22/gutjnl-2011-300651.full.pdf
Lieberman D, Moravec M, Holub J, Michaels L, Eisen G. Polyp size and advanced histology in patients undergoing colonoscopy screening: implications for CT colonography. Gastroenterology. 2008 Oct;135(4):1100-5. doi: 10.1053/j.gastro.2008.06.083. Epub 2008 Jul 3.
Chen SC, Rex DK. Endoscopist can be more powerful than age and male gender in predicting adenoma detection at colonoscopy. Am J Gastroenterol. 2007 Apr;102(4):856-61. Epub 2007 Jan 11.
Rex DK, Overhiser AJ, Chen SC, Cummings OW, Ulbright TM. Estimation of impact of American College of Radiology recommendations on CT colonography reporting for resection of high-risk adenoma findings. Am J Gastroenterol. 2009 Jan;104(1):149-53. doi: 10.1038/ajg.2008.35.
Butterly LF, Chase MP, Pohl H, Fiarman GS. Prevalence of clinically important histology in small adenomas. Clin Gastroenterol Hepatol. 2006 Mar;4(3):343-8.
Cairns S, Scholefield JH. Guidelines for colorectal cancer screening in high risk groups. Gut. 2002 Oct;51 Suppl 5:V1-2.
Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ; American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology. 2008 May;134(5):1570-95. doi: 10.1053/j.gastro.2008.02.002. Epub 2008 Feb 8. Review.
Lieberman DA, Weiss DG, Harford WV, Ahnen DJ, Provenzale D, Sontag SJ, Schnell TG, Chejfec G, Campbell DR, Kidao J, Bond JH, Nelson DB, Triadafilopoulos G, Ramirez FC, Collins JF, Johnston TK, McQuaid KR, Garewal H, Sampliner RE, Esquivel R, Robertson D. Five-year colon surveillance after screening colonoscopy. Gastroenterology. 2007 Oct;133(4):1077-85.
ASGE TECHNOLOGY COMMITTEE, Song LM, Adler DG, Conway JD, Diehl DL, Farraye FA, Kantsevoy SV, Kwon R, Mamula P, Rodriguez B, Shah RJ, Tierney WM. Narrow band imaging and multiband imaging. Gastrointest Endosc. 2008 Apr;67(4):581-9. doi: 10.1016/j.gie.2008.01.013. Review.
Cohen J. Optical contrast endoscopy: is it ready for routine use? Gastroenterology. 2009 Jan;136(1):52-5. doi: 10.1053/j.gastro.2008.11.053. Epub 2008 Dec 6.
East JE, Suzuki N, Saunders BP. Comparison of magnified pit pattern interpretation with narrow band imaging versus chromoendoscopy for diminutive colonic polyps: a pilot study. Gastrointest Endosc. 2007 Aug;66(2):310-6.
Konerding MA, Fait E, Gaumann A. 3D microvascular architecture of pre-cancerous lesions and invasive carcinomas of the colon. Br J Cancer. 2001 May 18;84(10):1354-62.
Sano Y, Ikematsu H, Fu KI, Emura F, Katagiri A, Horimatsu T, Kaneko K, Soetikno R, Yoshida S. Meshed capillary vessels by use of narrow-band imaging for differential diagnosis of small colorectal polyps. Gastrointest Endosc. 2009 Feb;69(2):278-83. doi: 10.1016/j.gie.2008.04.066. Epub 2008 Oct 25.
Hirata M, Tanaka S, Oka S, Kaneko I, Yoshida S, Yoshihara M, Chayama K. Evaluation of microvessels in colorectal tumors by narrow band imaging magnification. Gastrointest Endosc. 2007 Nov;66(5):945-52.
Rogart JN, Jain D, Siddiqui UD, Oren T, Lim J, Jamidar P, Aslanian H. Narrow-band imaging without high magnification to differentiate polyps during real-time colonoscopy: improvement with experience. Gastrointest Endosc. 2008 Dec;68(6):1136-45. doi: 10.1016/j.gie.2008.04.035. Epub 2008 Aug 8.
Rastogi A, Pondugula K, Bansal A, Wani S, Keighley J, Sugar J, Callahan P, Sharma P. Recognition of surface mucosal and vascular patterns of colon polyps by using narrow-band imaging: interobserver and intraobserver agreement and prediction of polyp histology. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):716-22. doi: 10.1016/j.gie.2008.09.058.
East JE, Suzuki N, Bassett P, Stavrinidis M, Thomas HJ, Guenther T, Tekkis PP, Saunders BP. Narrow band imaging with magnification for the characterization of small and diminutive colonic polyps: pit pattern and vascular pattern intensity. Endoscopy. 2008 Oct;40(10):811-7. doi: 10.1055/s-2008-1077586. Epub 2008 Sep 30.
Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.
Atkin WS, Saunders BP; British Society for Gastroenterology; Association of Coloproctology for Great Britain and Ireland. Surveillance guidelines after removal of colorectal adenomatous polyps. Gut. 2002 Oct;51 Suppl 5:V6-9.
Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.
Ignjatovic A, Thomas-Gibson S, East JE, Haycock A, Bassett P, Bhandari P, Man R, Suzuki N, Saunders BP. Development and validation of a training module on the use of narrow-band imaging in differentiation of small adenomas from hyperplastic colorectal polyps. Gastrointest Endosc. 2011 Jan;73(1):128-33. doi: 10.1016/j.gie.2010.09.021.
World Health Organisation. World Health Organisation classification of tumours:pathology and genetics of tumours of the digestive system. Lyon: IARC press. 2000.
NHS Bowel Cancer Screening Programme: Quality Assurance Guidelines for Colonoscopy. Andrew Chilton and Matt Rutter. March 2010. Available at: http://www.cancerscreening.nhs.uk/bowel/publications/nhsbcsp06.html

Responsible Party: South Tyneside NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01603927     History of Changes
Other Study ID Numbers: DISCARD2
PB-PG-1010-23222 ( Other Grant/Funding Number: NHS National Institute for Health Research )
First Submitted: May 17, 2012
First Posted: May 23, 2012
Last Update Posted: May 23, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical


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