Trial Outcomes & Findings for High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study (NCT NCT01761279)

NCT ID: NCT01761279

Last Updated: 2013-04-04

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

84 participants

Primary outcome timeframe

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

Results posted on

2013-04-04

Participant Flow

Patients attending for colonoscopy at Portsmouth Hospitals NHS Trust throught the Bowel Cancer Screening programme were recruited from May 2010-May 2011.

Cohort study - single cohort. Patients found to have inflammatory bowel disease or a polyposis syndrome were excluded

Participant milestones

Participant milestones
Measure	HDWL and i-Scan Assessment High Definition White Light Endoscopy.
Overall Study STARTED	84
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HDWL + I-Scan n=84 Participants High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
Age Continuous	67.6 Years n=93 Participants
Sex: Female, Male Female	25 Participants n=93 Participants
Sex: Female, Male Male	59 Participants n=93 Participants

PRIMARY outcome

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

Population: There were 84 patients included in the study. 209 polyps \<10mm included in the study.

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)

Outcome measures

Outcome measures
Measure	HDWL n=209 Polyps <10mm in size High Definition White Light Endoscopy	i-Scan n=209 Polyps <10mm in size High definition white light endoscopy with i-Scan image enhancement
Diagnostic Accuracy of In-vivo Polyp Assessment	93.3 % diagnostic accuracy Interval 88.5 to 96.3	94.7 % diagnostic accuracy Interval 90.3 to 97.2

SECONDARY outcome

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

Population: 134 is the number of adenomatous polyps included in the study.

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)

Outcome measures

Outcome measures
Measure	HDWL n=134 Adenomatous polyps <10mm in size High Definition White Light Endoscopy	i-Scan n=134 Adenomatous polyps <10mm in size High definition white light endoscopy with i-Scan image enhancement
Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size	95.5 Percentage sensitivity Interval 91.8 to 97.8	97.0 Percentage sensitivity Interval 93.6 to 98.9

SECONDARY outcome

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

Population: 75 is the number of non-neoplastic polyps included in the study.

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)

Outcome measures

Outcome measures
Measure	HDWL n=75 Non-neoplastic polyps <10mm in size High Definition White Light Endoscopy	i-Scan n=75 Non-neoplastic polyps <10mm in size High definition white light endoscopy with i-Scan image enhancement
Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size	89.3 Percentage specificity Interval 82.7 to 93.5	90.7 Percentage specificity Interval 84.5 to 94.0

SECONDARY outcome

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

Population: Numbers indicate the number of rectosigmoid polyps \<5mm in size assessed as being non-neoplastic

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)

Outcome measures

Outcome measures
Measure	HDWL n=46 Rectosigmoid Polyps <5mm High Definition White Light Endoscopy	i-Scan n=48 Rectosigmoid Polyps <5mm High definition white light endoscopy with i-Scan image enhancement
Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size	100 Percentage Negative Predictive Value Interval 92.8 to 100.0	100 Percentage Negative Predictive Value Interval 93.4 to 100.0

OTHER_PRE_SPECIFIED outcome

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

Population: 84 study participants in total. One patient excluded from this analysis as a single polyp was not retrieved for histological analysis.

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

Outcome measures

Outcome measures
Measure	HDWL n=83 Participants High Definition White Light Endoscopy	i-Scan n=83 Participants High definition white light endoscopy with i-Scan image enhancement
Accuracy of Prediction of Polyp Surveillence Intervals	95.3 Percentage correct surveillence interval	97.2 Percentage correct surveillence interval

Adverse Events

HDWL + I-Scan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Pete Basford, Endoscopy Research Fellow

Portsmouth Hospitals NHS Trust

Phone: +447890990445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place