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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 Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Colonic Polyps
Intervention Procedure: High definition white light endoscopy
Enrollment 84
Recruitment Details Patients attending for colonoscopy at Portsmouth Hospitals NHS Trust throught the Bowel Cancer Screening programme were recruited from May 2010-May 2011.
Pre-assignment Details Cohort study - single cohort. Patients found to have inflammatory bowel disease or a polyposis syndrome were excluded
Arm/Group Title HDWL and i-Scan Assessment
Hide Arm/Group Description High Definition White Light Endoscopy.
Period Title: Overall Study
Started 84
Completed 84
Not Completed 0
Arm/Group Title HDWL + I-Scan
Hide Arm/Group Description High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
Overall Number of Baseline Participants 84
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants
67.6
(60 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants
Female
25
  29.8%
Male
59
  70.2%
1.Primary Outcome
Title Diagnostic Accuracy of In-vivo Polyp Assessment
Hide Description 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)
Time Frame Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Hide Outcome Measure Data
Hide Analysis Population Description
There were 84 patients included in the study. 209 polyps <10mm included in the study.
Arm/Group Title HDWL i-Scan
Hide Arm/Group Description:
High Definition White Light Endoscopy
High definition white light endoscopy with i-Scan image enhancement
Overall Number of Participants Analyzed 84 84
Overall Number of Units Analyzed
Type of Units Analyzed: Polyps <10mm in size
209 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % diagnostic accuracy
93.3
(88.5 to 96.3)
94.7
(90.3 to 97.2)
2.Secondary Outcome
Title Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size
Hide Description 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)
Time Frame Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Hide Outcome Measure Data
Hide Analysis Population Description
134 is the number of adenomatous polyps included in the study.
Arm/Group Title HDWL i-Scan
Hide Arm/Group Description:
High Definition White Light Endoscopy
High definition white light endoscopy with i-Scan image enhancement
Overall Number of Participants Analyzed 84 84
Overall Number of Units Analyzed
Type of Units Analyzed: Adenomatous polyps <10mm in size
134 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage sensitivity
95.5
(91.8 to 97.8)
97.0
(93.6 to 98.9)
3.Secondary Outcome
Title Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size
Hide Description 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)
Time Frame Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Hide Outcome Measure Data
Hide Analysis Population Description
75 is the number of non-neoplastic polyps included in the study.
Arm/Group Title HDWL i-Scan
Hide Arm/Group Description:
High Definition White Light Endoscopy
High definition white light endoscopy with i-Scan image enhancement
Overall Number of Participants Analyzed 84 84
Overall Number of Units Analyzed
Type of Units Analyzed: Non-neoplastic polyps <10mm in size
75 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage specificity
89.3
(82.7 to 93.5)
90.7
(84.5 to 94.0)
4.Secondary Outcome
Title Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size
Hide Description 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)
Time Frame Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Numbers indicate the number of rectosigmoid polyps <5mm in size assessed as being non-neoplastic
Arm/Group Title HDWL i-Scan
Hide Arm/Group Description:
High Definition White Light Endoscopy
High definition white light endoscopy with i-Scan image enhancement
Overall Number of Participants Analyzed 84 84
Overall Number of Units Analyzed
Type of Units Analyzed: Rectosigmoid Polyps <5mm
46 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage Negative Predictive Value
100
(92.8 to 100)
100
(93.4 to 100)
5.Other Pre-specified Outcome
Title Accuracy of Prediction of Polyp Surveillence Intervals
Hide Description 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
Time Frame Once histopathology results are known, approximately 2 weeks after in-vivo assessment
Hide Outcome Measure Data
Hide Analysis Population Description
84 study participants in total. One patient excluded from this analysis as a single polyp was not retrieved for histological analysis.
Arm/Group Title HDWL i-Scan
Hide Arm/Group Description:
High Definition White Light Endoscopy
High definition white light endoscopy with i-Scan image enhancement
Overall Number of Participants Analyzed 83 83
Measure Type: Number
Unit of Measure: Percentage correct surveillence interval
95.3 97.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HDWL + I-Scan
Hide Arm/Group Description High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
All-Cause Mortality
HDWL + I-Scan
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HDWL + I-Scan
Affected / at Risk (%)
Total   0/84 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
HDWL + I-Scan
Affected / at Risk (%)
Total   0/84 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Pete Basford, Endoscopy Research Fellow
Organization: Portsmouth Hospitals NHS Trust
Phone: +447890990445
EMail: petebasford@hotmail.com
Publications:
Layout table for additonal information
Responsible Party: Pradeep Bhandari, Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01761279     History of Changes
Other Study ID Numbers: PHT/2009/046
First Submitted: January 3, 2013
First Posted: January 4, 2013
Results First Submitted: January 7, 2013
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013