Colonic PolypsHiSCOPENCT01761279
High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study
An observational study of Colonic Polyps, run by Portsmouth Hospitals NHS Trust.
Trial summary
Current standard practice is to remove all colonic polyps found during colonoscopy as it has not been possible to distinguish between polyps with some malignant potential (adenomatous) and those with negligable malignant potential (non-adenomatous). Read more about this study
- Who is it for?
- Ages 60 to 74 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- High definition white light endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UK Bowel Cancer Screening patients attending for colonoscopy
Who may be able to join
- Patients found to have colonic polyps up to 10mm in size
Who cannot join
- Poor bowel preparation
- Inflammatory bowel disease
- Polyposis syndrome
About this study
Official title: A Prospective Single-blind Observational Cohort Study of High Definition White Light Endoscopy and i-Scan Image Enhancement for the Characterisation of Small Colonic Polyps
Current standard practice is to remove all colonic polyps found during colonoscopy as it has not been possible to distinguish between polyps with some malignant potential (adenomatous) and those with negligable malignant potential (non-adenomatous).
Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish between these two types of polyps by examining minute surface details.
Read more
i-Scan is a new digital enhancement method that aims to enhance surface details and may enable similar accurate distinction between adenomatous and non-adenomatous polyps.
Hypothesis:
High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.
Read the detailed description
Traditionally all polyps detected at colonoscopy, except obvious cancers, have been removed. It is felt that small (<10mm diameter) hyperplastic polyps cannot be reliably distinguished from adenomatous polyps by endoscopists [1]. Therefore a large number of hyperplastic polyps are removed unnecessarily. This results in increased risk to patients through exposing them to unnecessary polypectomy, and increased cost to the health service through the cost of processing greater numbers of histopathology specimens. The cost per specimen is around £58.
This challenge of distinguishing small hyperplastic polyps from small adenomatous polyps has been met over the past decade through the use of novel chromoendoscopy and computed 'virtual chromoendoscopy' techniques.
Chromoendoscopy involves using staining or contrast dyes to highlight the minute surface patterns in the mucosa of the gastrointestinal tract. The dyes are applied to the colonic mucosa via the working channels of the endoscope. Vital stains such as cresyl violet and methylene blue, which are taken up into epithelial cells, have been used by Japanese endoscopists for many years. Work by Kudo et al showed that by using these stains in combination with magnification endoscopy the minute 'pit patterns' of colonic mucosal lesions could be precisely examined and classified. The pits described are the surface opening of the mucosal crypts. Kudo showed that the surface pit pattern could predict the histology of a lesion with high accuracy [2-4], enabling distinction between adenomatous and hyperplastic polyps. Concerns regarding potential harmful effects of vital stains increased the popularity of an alternative chromoendoscopy dye, indigocarmine [5]. Indigocarmine is not taken up by cells but lies on the colonic wall. Studies from East Asia, the USA and Europe published in the early part of the last decade showed that by combining indigocarmine and magnification endoscopy, neoplastic colonic polyps (adenomas) could be distinguished from non-neoplastic hyperplastic polyps with accuracy rates of 68-96% [6-10]. By the same method, surface patterns could also identify small early colorectal cancers[11] . Subsequent studies demonstrated that indigocarmine could adequately distinguish between adenomatous and hyperplastic polyps without the need for optical magnification [12-15].
During the past few years new methods of closely examining lesions within the colon have been developed. Digital imaging techniques or 'virtual chromoendoscopy' systems have been developed by endoscope manufacturers as a 'push-button' alternative to chromoendoscopy dyes, being potentially simpler and quicker to use. The first of these novel technologies available was the narrow band imaging (NBI) system produced by Olympus. A filter within the endoscope selects out narrow bandwidths of blue and green light, and thus reduces red light. These wavelengths penetrate only the superficial layers of the mucosa, highlighting surface patterns and microvasculature. Adenomatous polyps have more numerous and prominent microvessels in comparison to hyperplastic poylps. This system has been shown to be effective in differentiating small hyperplastic and adenomatous polyps with accuracies of 91 - 94% [16-23].
The Fujinon Intelligent Colour Enhancement (FICE) system developed by Fujinon uses post-processor electronic colour filter technology to allow a range of filter images with different wavelengths of light to be viewed. Similar results to NBI have been achieved in the characterisation of small polyps [13, 24, 25].
More recently a further virtual chromoendoscopy system, i-Scan has been developed by Pentax. i-Scan identifies areas of contrast between adjacent pixels (ie light bordering dark) and enhances this contrast. Additionally in a similar method to FICE, post-processor manipulation of the red, green and blue components of the spectrum is used to enhance vessels and surface structures.
A single study from Germany has suggested that i-Scan improves the detection of lesions during flexible sigmoidoscopy and can accurately predict histology. There is a need for further data on the clinical efficacy of i-Scan in the assessment of colonic polyps, particularly in a UK population and in a bowel cancer screening population, neither of which have been studied to date.
Through the use of these new technologies it may be possible to accurately predict the histology of small polyps in real time. Once an in-vivo diagnosis has been made with high confidence it may be possible for small hyperplastic polyps to be discarded, rather than sent for histological analysis, or to be left in situ [22]. This has potential benefits in reducing the frequency and consequent risk of polypectomy for patients and could also reduce pathology costs. UK and US guidelines for repeat surveillance colonoscopy after adenomas are detected at baseline examination are based on the number and size and histology of adenomas [26, 27]. At present these 'rescope intervals' are determined once the histology report of any resected polyps is received. With accurate in-vivo diagnosis these intervals may be set immediately after the baseline colonoscopy has been completed.
Whilst the development of these endoscopic advanced imaging technologies is to be welcomed, it is important for studies to determine what can be achieved through their use, over and above standard white-light colonoscopy. The American Society for Gastrointestinal Endoscopy has identified the utility of technologies used in the real-time assessment of diminutive (<5mm) colonic polyps as a key area for study, and has published guidelines on the minimum standards which new endoscopic technologies should meet before their use becomes widely adopted [28].
We aim to evaluate HDWL and HDWL + i-Scan for the real time assessment and prediction of histology of small colonic polyps in a BCSP population.
- Conditions
- Colonic Polyps
- Being tested
- High definition white light endoscopy
- Keywords
- Colonic polyps
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition white light endoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of In-vivo Polyp Assessment
Diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Accuracy compared to the gold standard of histopathology. Accuracy - number of polyps with histology correctly predicted by in-vivo method/total number of polyps assessed (Expressed as a percentage)
Measured: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Secondary outcomes (3)
Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size
Sensitivity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Sensitivity compared to the gold standard of histopathology. Senstivity for adenomatous histology = number of correctly identified adenomas (true positives)/total number of adenomas (true positives + false negatives)
Measured: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size
Specificity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Specificity compared to the gold standard of histopathology. Specificity for adenomatous histology = number of correctly identified non-neoplastic polyps (true negatives)/total number of non-neoplastic polyps (true negatives + false positives)
Measured: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size
Negative predictive value for adenomatous histology of rectosigmoid polyps ≤5mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. NPV compared to the gold standard of histopathology. Negative predictive value = number of true negatives/(number of true negatives + number of false negatives)
Measured: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pradeep Bhandari, Portsmouth Hospitals NHS Trust
- Investigators
- Pradeep Bhandari, MBBS, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761279
- Sponsor's protocol ID
- PHT/2009/046
- Acronym
- HiSCOPE
- Status last verified
- Feb 2013
- First submitted
- 3 Jan 2013
- Last updated
- 4 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Norfleet RG, Ryan ME, Wyman JB. Adenomatous and hyperplastic polyps cannot be reliably distinguished by their appearance through the fiberoptic sigmoidoscope. Dig Dis Sci. 1988 Sep;33(9):1175-7. doi: 10.1007/BF01535796.
PubMed 3044716Kudo S, Hirota S, Nakajima T, Hosobe S, Kusaka H, Kobayashi T, Himori M, Yagyuu A. Colorectal tumours and pit pattern. J Clin Pathol. 1994 Oct;47(10):880-5. doi: 10.1136/jcp.47.10.880.
PubMed 7962600Kudo S, Rubio CA, Teixeira CR, Kashida H, Kogure E. Pit pattern in colorectal neoplasia: endoscopic magnifying view. Endoscopy. 2001 Apr;33(4):367-73. doi: 10.1055/s-2004-826104. No abstract available.
PubMed 11315901Kudo S, Tamura S, Nakajima T, Yamano H, Kusaka H, Watanabe H. Diagnosis of colorectal tumorous lesions by magnifying endoscopy. Gastrointest Endosc. 1996 Jul;44(1):8-14. doi: 10.1016/s0016-5107(96)70222-5.
PubMed 8836710Davies J, Burke D, Olliver JR, Hardie LJ, Wild CP, Routledge MN. Methylene blue but not indigo carmine causes DNA damage to colonocytes in vitro and in vivo at concentrations used in clinical chromoendoscopy. Gut. 2007 Jan;56(1):155-6. doi: 10.1136/gut.2006.107300. No abstract available.
PubMed 17172595De Palma GD, Rega M, Masone S, Persico M, Siciliano S, Addeo P, Persico G. Conventional colonoscopy and magnified chromoendoscopy for the endoscopic histological prediction of diminutive colorectal polyps: a single operator study. World J Gastroenterol. 2006 Apr 21;12(15):2402-5. doi: 10.3748/wjg.v12.i15.2402.
PubMed 16688833Eisen GM, Kim CY, Fleischer DE, Kozarek RA, Carr-Locke DL, Li TC, Gostout CJ, Heller SJ, Montgomery EA, Al-Kawas FH, Lewis JH, Benjamin SB. High-resolution chromoendoscopy for classifying colonic polyps: a multicenter study. Gastrointest Endosc. 2002 May;55(6):687-94. doi: 10.1067/mge.2002.123619.
PubMed 11979251Fu KI, Sano Y, Kato S, Fujii T, Nagashima F, Yoshino T, Okuno T, Yoshida S, Fujimori T. Chromoendoscopy using indigo carmine dye spraying with magnifying observation is the most reliable method for differential diagnosis between non-neoplastic and neoplastic colorectal lesions: a prospective study. Endoscopy. 2004 Dec;36(12):1089-93. doi: 10.1055/s-2004-826039.
PubMed 15578300Konishi K, Kaneko K, Kurahashi T, Yamamoto T, Kushima M, Kanda A, Tajiri H, Mitamura K. A comparison of magnifying and nonmagnifying colonoscopy for diagnosis of colorectal polyps: A prospective study. Gastrointest Endosc. 2003 Jan;57(1):48-53. doi: 10.1067/mge.2003.31.
PubMed 12518130Tung SY, Wu CS, Su MY. Magnifying colonoscopy in differentiating neoplastic from nonneoplastic colorectal lesions. Am J Gastroenterol. 2001 Sep;96(9):2628-32. doi: 10.1111/j.1572-0241.2001.04120.x.
PubMed 11569686Kato S, Fujii T, Koba I, Sano Y, Fu KI, Parra-Blanco A, Tajiri H, Yoshida S, Rembacken B. Assessment of colorectal lesions using magnifying colonoscopy and mucosal dye spraying: can significant lesions be distinguished? Endoscopy. 2001 Apr;33(4):306-10. doi: 10.1055/s-2001-13700.
PubMed 11315890Sonwalkar S, Rotimi O, Rembacken BJ. Characterization of colonic polyps at conventional (nonmagnifying) colonoscopy after spraying with 0.2 % indigo carmine dye. Endoscopy. 2006 Dec;38(12):1218-23. doi: 10.1055/s-2006-944787.
PubMed 17163322Pohl J, Lotterer E, Balzer C, Sackmann M, Schmidt KD, Gossner L, Schaab C, Frieling T, Medve M, Mayer G, Nguyen-Tat M, Ell C. Computed virtual chromoendoscopy versus standard colonoscopy with targeted indigocarmine chromoscopy: a randomised multicentre trial. Gut. 2009 Jan;58(1):73-8. doi: 10.1136/gut.2008.153601. Epub 2008 Oct 6.
PubMed 18838485Su MY, Hsu CM, Ho YP, Chen PC, Lin CJ, Chiu CT. Comparative study of conventional colonoscopy, chromoendoscopy, and narrow-band imaging systems in differential diagnosis of neoplastic and nonneoplastic colonic polyps. Am J Gastroenterol. 2006 Dec;101(12):2711-6. doi: 10.1111/j.1572-0241.2006.00932.x.
PubMed 17227517Apel D, Jakobs R, Schilling D, Weickert U, Teichmann J, Bohrer MH, Riemann JF. Accuracy of high-resolution chromoendoscopy in prediction of histologic findings in diminutive lesions of the rectosigmoid. Gastrointest Endosc. 2006 May;63(6):824-8. doi: 10.1016/j.gie.2005.09.013.
PubMed 16650546
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-blind Observational Cohort Study of High Definition White Light Endoscopy and i-Scan Image Enhancement for the Characterisation of Small Colonic Polyps
- ClinicalTrials.gov ID
- NCT01761279
- Acronym / sponsor ID
- HiSCOPE / PHT/2009/046
- Conditions
- Colonic Polyps
- Keywords
- Colonic polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current standard practice is to remove all colonic polyps found during colonoscopy as it has not been possible to distinguish between polyps with some malignant potential (adenomatous) and those with negligable malignant potential (non-adenomatous).
Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish between these two types of polyps by examining minute surface details.
i-Scan is a new digital enhancement method that aims to enhance surface details and may enable similar accurate distinction between adenomatous and non-adenomatous polyps.
Hypothesis:
High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.
Detailed description
Traditionally all polyps detected at colonoscopy, except obvious cancers, have been removed. It is felt that small (<10mm diameter) hyperplastic polyps cannot be reliably distinguished from adenomatous polyps by endoscopists [1]. Therefore a large number of hyperplastic polyps are removed unnecessarily. This results in increased risk to patients through exposing them to unnecessary polypectomy, and increased cost to the health service through the cost of processing greater numbers of histopathology specimens. The cost per specimen is around £58.
This challenge of distinguishing small hyperplastic polyps from small adenomatous polyps has been met over the past decade through the use of novel chromoendoscopy and computed 'virtual chromoendoscopy' techniques.
Chromoendoscopy involves using staining or contrast dyes to highlight the minute surface patterns in the mucosa of the gastrointestinal tract. The dyes are applied to the colonic mucosa via the working channels of the endoscope. Vital stains such as cresyl violet and methylene blue, which are taken up into epithelial cells, have been used by Japanese endoscopists for many years. Work by Kudo et al showed that by using these stains in combination with magnification endoscopy the minute 'pit patterns' of colonic mucosal lesions could be precisely examined and classified. The pits described are the surface opening of the mucosal crypts. Kudo showed that the surface pit pattern could predict the histology of a lesion with high accuracy [2-4], enabling distinction between adenomatous and hyperplastic polyps. Concerns regarding potential harmful effects of vital stains increased the popularity of an alternative chromoendoscopy dye, indigocarmine [5]. Indigocarmine is not taken up by cells but lies on the colonic wall. Studies from East Asia, the USA and Europe published in the early part of the last decade showed that by combining indigocarmine and magnification endoscopy, neoplastic colonic polyps (adenomas) could be distinguished from non-neoplastic hyperplastic polyps with accuracy rates of 68-96% [6-10]. By the same method, surface patterns could also identify small early colorectal cancers[11] . Subsequent studies demonstrated that indigocarmine could adequately distinguish between adenomatous and hyperplastic polyps without the need for optical magnification [12-15].
During the past few years new methods of closely examining lesions within the colon have been developed. Digital imaging techniques or 'virtual chromoendoscopy' systems have been developed by endoscope manufacturers as a 'push-button' alternative to chromoendoscopy dyes, being potentially simpler and quicker to use. The first of these novel technologies available was the narrow band imaging (NBI) system produced by Olympus. A filter within the endoscope selects out narrow bandwidths of blue and green light, and thus reduces red light. These wavelengths penetrate only the superficial layers of the mucosa, highlighting surface patterns and microvasculature. Adenomatous polyps have more numerous and prominent microvessels in comparison to hyperplastic poylps. This system has been shown to be effective in differentiating small hyperplastic and adenomatous polyps with accuracies of 91 - 94% [16-23].
The Fujinon Intelligent Colour Enhancement (FICE) system developed by Fujinon uses post-processor electronic colour filter technology to allow a range of filter images with different wavelengths of light to be viewed. Similar results to NBI have been achieved in the characterisation of small polyps [13, 24, 25].
More recently a further virtual chromoendoscopy system, i-Scan has been developed by Pentax. i-Scan identifies areas of contrast between adjacent pixels (ie light bordering dark) and enhances this contrast. Additionally in a similar method to FICE, post-processor manipulation of the red, green and blue components of the spectrum is used to enhance vessels and surface structures.
A single study from Germany has suggested that i-Scan improves the detection of lesions during flexible sigmoidoscopy and can accurately predict histology. There is a need for further data on the clinical efficacy of i-Scan in the assessment of colonic polyps, particularly in a UK population and in a bowel cancer screening population, neither of which have been studied to date.
Through the use of these new technologies it may be possible to accurately predict the histology of small polyps in real time. Once an in-vivo diagnosis has been made with high confidence it may be possible for small hyperplastic polyps to be discarded, rather than sent for histological analysis, or to be left in situ [22]. This has potential benefits in reducing the frequency and consequent risk of polypectomy for patients and could also reduce pathology costs. UK and US guidelines for repeat surveillance colonoscopy after adenomas are detected at baseline examination are based on the number and size and histology of adenomas [26, 27]. At present these 'rescope intervals' are determined once the histology report of any resected polyps is received. With accurate in-vivo diagnosis these intervals may be set immediately after the baseline colonoscopy has been completed.
Whilst the development of these endoscopic advanced imaging technologies is to be welcomed, it is important for studies to determine what can be achieved through their use, over and above standard white-light colonoscopy. The American Society for Gastrointestinal Endoscopy has identified the utility of technologies used in the real-time assessment of diminutive (<5mm) colonic polyps as a key area for study, and has published guidelines on the minimum standards which new endoscopic technologies should meet before their use becomes widely adopted [28].
We aim to evaluate HDWL and HDWL + i-Scan for the real time assessment and prediction of histology of small colonic polyps in a BCSP population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UK Bowel Cancer Screening patients attending for colonoscopy
Key inclusion criteria (1 listed)
- Patients found to have colonic polyps up to 10mm in size
Key exclusion criteria (3 listed)
- Poor bowel preparation
- Inflammatory bowel disease
- Polyposis syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High definition white light endoscopy | Procedure or surgery | – |
Primary outcome
Diagnostic Accuracy of In-vivo Polyp Assessment
Time frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Accuracy compared to the gold standard of histopathology. Accuracy - number of polyps with histology correctly predicted by in-vivo method/total number of polyps assessed (Expressed as a percentage)
3 secondary outcomes
Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size
Time frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size
Time frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size
Time frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3044716Norfleet RG, Ryan ME, Wyman JB. Adenomatous and hyperplastic polyps cannot be reliably distinguished by their appearance through the fiberoptic sigmoidoscope. Dig Dis Sci. 1988 Sep;33(9):1175-7. doi: 10.1007/BF01535796.
- Background: PubMed 7962600Kudo S, Hirota S, Nakajima T, Hosobe S, Kusaka H, Kobayashi T, Himori M, Yagyuu A. Colorectal tumours and pit pattern. J Clin Pathol. 1994 Oct;47(10):880-5. doi: 10.1136/jcp.47.10.880.
- Background: PubMed 11315901Kudo S, Rubio CA, Teixeira CR, Kashida H, Kogure E. Pit pattern in colorectal neoplasia: endoscopic magnifying view. Endoscopy. 2001 Apr;33(4):367-73. doi: 10.1055/s-2004-826104. No abstract available.
- Background: PubMed 8836710Kudo S, Tamura S, Nakajima T, Yamano H, Kusaka H, Watanabe H. Diagnosis of colorectal tumorous lesions by magnifying endoscopy. Gastrointest Endosc. 1996 Jul;44(1):8-14. doi: 10.1016/s0016-5107(96)70222-5.
- Background: PubMed 17172595Davies J, Burke D, Olliver JR, Hardie LJ, Wild CP, Routledge MN. Methylene blue but not indigo carmine causes DNA damage to colonocytes in vitro and in vivo at concentrations used in clinical chromoendoscopy. Gut. 2007 Jan;56(1):155-6. doi: 10.1136/gut.2006.107300. No abstract available.
- Background: PubMed 16688833De Palma GD, Rega M, Masone S, Persico M, Siciliano S, Addeo P, Persico G. Conventional colonoscopy and magnified chromoendoscopy for the endoscopic histological prediction of diminutive colorectal polyps: a single operator study. World J Gastroenterol. 2006 Apr 21;12(15):2402-5. doi: 10.3748/wjg.v12.i15.2402.
- Background: PubMed 11979251Eisen GM, Kim CY, Fleischer DE, Kozarek RA, Carr-Locke DL, Li TC, Gostout CJ, Heller SJ, Montgomery EA, Al-Kawas FH, Lewis JH, Benjamin SB. High-resolution chromoendoscopy for classifying colonic polyps: a multicenter study. Gastrointest Endosc. 2002 May;55(6):687-94. doi: 10.1067/mge.2002.123619.
- Background: PubMed 15578300Fu KI, Sano Y, Kato S, Fujii T, Nagashima F, Yoshino T, Okuno T, Yoshida S, Fujimori T. Chromoendoscopy using indigo carmine dye spraying with magnifying observation is the most reliable method for differential diagnosis between non-neoplastic and neoplastic colorectal lesions: a prospective study. Endoscopy. 2004 Dec;36(12):1089-93. doi: 10.1055/s-2004-826039.
- Background: PubMed 12518130Konishi K, Kaneko K, Kurahashi T, Yamamoto T, Kushima M, Kanda A, Tajiri H, Mitamura K. A comparison of magnifying and nonmagnifying colonoscopy for diagnosis of colorectal polyps: A prospective study. Gastrointest Endosc. 2003 Jan;57(1):48-53. doi: 10.1067/mge.2003.31.
- Background: PubMed 11569686Tung SY, Wu CS, Su MY. Magnifying colonoscopy in differentiating neoplastic from nonneoplastic colorectal lesions. Am J Gastroenterol. 2001 Sep;96(9):2628-32. doi: 10.1111/j.1572-0241.2001.04120.x.
- Background: PubMed 11315890Kato S, Fujii T, Koba I, Sano Y, Fu KI, Parra-Blanco A, Tajiri H, Yoshida S, Rembacken B. Assessment of colorectal lesions using magnifying colonoscopy and mucosal dye spraying: can significant lesions be distinguished? Endoscopy. 2001 Apr;33(4):306-10. doi: 10.1055/s-2001-13700.
- Background: PubMed 17163322Sonwalkar S, Rotimi O, Rembacken BJ. Characterization of colonic polyps at conventional (nonmagnifying) colonoscopy after spraying with 0.2 % indigo carmine dye. Endoscopy. 2006 Dec;38(12):1218-23. doi: 10.1055/s-2006-944787.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Bhandari, MBBS principal investigator
Portsmouth Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyps, run by Portsmouth Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of In-vivo Polyp Assessment (time frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761279, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013; AzTrials last refreshed its copy on 30 Oct 2026.