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High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study (HiSCOPE)

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ClinicalTrials.gov Identifier: NCT01761279
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Pradeep Bhandari, Portsmouth Hospitals NHS Trust

Study Description
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Brief 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).

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.


Condition or disease Intervention/treatment
Colonic Polyps Procedure: High definition white light endoscopy

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Study Design
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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size [ Time Frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment ]
    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)

  2. Specificity 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 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)

  3. 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 ]
    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)


Other Outcome Measures:
  1. Accuracy of Prediction of Polyp Surveillence Intervals [ Time Frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment ]
    Accuracy of prediction of post-polypectomy surveillence colonoscopy intervasl based on national guidelines. Intervals based on in-vivo assessment of all polyps ≤5mm in size combined with histopathology of polyps >5mm in size will be compared to intervals determined by histopathology of all polyps


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UK Bowel Cancer Screening patients attending for colonoscopy
Criteria

Inclusion Criteria:

  • Patients found to have colonic polyps up to 10mm in size

Exclusion Criteria:

  • Poor bowel preparation
  • Inflammatory bowel disease
  • Polyposis syndrome
Contacts and Locations
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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): NCT01761279


Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Investigators
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Principal Investigator: Pradeep Bhandari, MBBS Portsmouth Hospitals NHS Trust
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pradeep Bhandari, Professor of Gastroenterology, Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01761279     History of Changes
Other Study ID Numbers: PHT/2009/046
First Posted: January 4, 2013    Key Record Dates
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013
Last Verified: February 2013
Keywords provided by Pradeep Bhandari, Portsmouth Hospitals NHS Trust:
Colonic polyps
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps