Detect InSpect ChAracterise Resect and Discard 2

NCT01603927 | Unknown DMC

• 2 other identifiers: DISCARD2PB-PG-1010-23222
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

• The sensitivity NBI optical diagnosis in determining colonoscopy surveillance intervals.

  The proportion of individuals requiring surveillance colonoscopy (according to British Society of Gastroenterology Guidelines)that are correctly identified by NBI optical diagnosis (test sensitivity).

  12 months

Secondary Outcomes (4)

• The sensitivity, specificity and accuracy of optical diagnosis on a per polyp basis.

  12 months

• The learning curve and maintenance of accuracy of optical diagnosis.

  12 months

• The economic implications of replacing histological assessment with optical diagnosis.

  12 months

• Description of the population undergoing routine colonoscopy and prevalence of polyps and polyp type.

  12 months

Study Arms (1)

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).

Interventions

Narrow band imaging for 'optical diagnosis' of colonic polyps (Olympus). DEVICE

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.

Colonoscopy with Narrow band imaging (NBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending for routine diagnostic or screening colonoscopy.

You may qualify if:

• Phase 1
• Patients able to provide valid informed consent.
• Patients over 18 years of age.
• Patients attending for routine colonoscopy.
• Phase 2
• Patients with one or more polyps under 10mm detected at colonoscopy.
• Patients undergoing a complete colonoscopy confirmed by photo documentation of caecal landmarks.

You may not qualify if:

• 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).

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead
• University of Durham: collaborator

Study Sites (5)

County Durham and Darlington NHS Foundation Trust

Darlington, County Durham, DL3 6HX, United Kingdom

Location

North Cumbria University Hospitals NHS Trust

Carlisle, Cumbria, CA2 7HY, United Kingdom

Location

Northumbria Healthcare NHS Trust

Ashington, Northumberland, NE63 9JJ, United Kingdom

Location

South Tees NHS Trust

Middlesbrough, Teeside, TS4 3BW, United Kingdom

Location

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, Teeside, TS19 8PE, United Kingdom

Location

Related Publications (28)

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  BACKGROUND

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• 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. doi: 10.1016/j.gie.2007.02.026.

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• 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.

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• 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.

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• 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.

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• 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.

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• World Health Organisation. World Health Organisation classification of tumours:pathology and genetics of tumours of the digestive system. Lyon: IARC press. 2000.

  BACKGROUND

• 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

  BACKGROUND

• Rees CJ, Rajasekhar PT, Wilson A, Close H, Rutter MD, Saunders BP, East JE, Maier R, Moorghen M, Muhammad U, Hancock H, Jayaprakash A, MacDonald C, Ramadas A, Dhar A, Mason JM. Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study. Gut. 2017 May;66(5):887-895. doi: 10.1136/gutjnl-2015-310584. Epub 2016 Apr 19.

  PMID: 27196576 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Colin J Rees, MBBS, FRCP

CONTACT

(0191) 4041000; colin.rees@stft.nhs.uk

Praveen T Rajasekhar, MBChB BMedSci MRCP

CONTACT

(0191) 4041000; praveen.rajasekhar@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 23, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

GB (5)