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

NCT01761279 | Completed Results

• 1 other identifier: PHT/2009/046
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonic Polyps

Keywords

Colonic polyps

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  Once histopathology results are known, approximately 2 weeks after in-vivo assessment

• Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size

  Once histopathology results are known, approximately 2 weeks after in-vivo assessment

• Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size

  Once histopathology results are known, approximately 2 weeks after in-vivo assessment

Other Outcomes (1)

• Accuracy of Prediction of Polyp Surveillence Intervals

  Once histopathology results are known, approximately 2 weeks after in-vivo assessment

Interventions

High definition white light endoscopy PROCEDURE

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UK Bowel Cancer Screening patients attending for colonoscopy

You may qualify if:

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

You may not qualify if:

• Poor bowel preparation
• Inflammatory bowel disease
• Polyposis syndrome

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

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• Basford PJ, Longcroft-Wheaton G, Higgins B, Bhandari P. High-definition endoscopy with i-Scan for evaluation of small colon polyps: the HiSCOPE study. Gastrointest Endosc. 2014 Jan;79(1):111-8. doi: 10.1016/j.gie.2013.06.013. Epub 2013 Jul 17.

  PMID: 23871094 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Single centre study. Single endoscopist.

Results Point of Contact

• Title: Dr Pete Basford, Endoscopy Research Fellow
• Organization: Portsmouth Hospitals NHS Trust

petebasford@hotmail.com

+447890990445

Study Officials

• Pradeep Bhandari, MBBS

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 4, 2013
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 4, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-02