Detect InSpect ChAracterise Resect and Discard 2 - Full Text View

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:

MedlinePlus related topics: Colonic Polyps Colonoscopy Diagnostic Imaging

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Potential cost saving of optical diagnosis
Description of the population undergoing routine colonoscopy and prevalence of polyps and polyp type. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients attending for routine diagnostic or screening colonoscopy.

Criteria

Inclusion Criteria:

Phase 1

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

Phase 2

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

Exclusion Criteria:

Patients with known inflammatory bowel disease (ulcerative colitis of Crohns disease) or known polyposis syndromes.
Patients who lack capacity to give informed consent as assessed by the clinical study team member taking consent.
Patients who are known to be pregnant (self-reported).

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: 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:

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.

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, Pickard 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, 9 e1-3.


Responsible Party:	South Tyneside NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01603927 History of Changes
Other Study ID Numbers:	DISCARD2, PB-PG-1010-23222
Study First Received:	May 17, 2012
Last Updated:	May 22, 2012
Health Authority:	United Kingdom: National Institute for Health Research

ClinicalTrials.gov processed this record on February 27, 2015

Detect InSpect ChAracterise Resect and Discard 2 (DISCARD2)