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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pradeep Bhandari, Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01761279
First received: January 3, 2013
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Colonic Polyps
 Procedure: High definition white light endoscopy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Portsmouth Hospitals NHS Trust:

Primary Outcome Measures:
  • Diagnostic Accuracy of In-vivo Polyp Assessment [ Time Frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment ] [ Designated as safety issue: No ]
    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:
  • Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size [ Time Frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment ] [ Designated as safety issue: No ]
    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)

  • Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size [ Time Frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Accuracy of Prediction of Polyp Surveillence Intervals [ Time Frame: Once histopathology results are known, approximately 2 weeks after in-vivo assessment ] [ Designated as safety issue: No ]
    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


Enrollment: 84
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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  Eligibility

Ages Eligible for Study:   60 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761279

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

Publications:

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
Study First Received: January 3, 2013
Results First Received: January 7, 2013
Last Updated: February 25, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Portsmouth Hospitals NHS Trust:
Colonic polyps

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

ClinicalTrials.gov processed this record on May 19, 2013