NCT02929381

Advanced Endoscopic Imaging in Colonoscopy

A Prospective Randomized Clinical Trial to Assess the Utility of Advanced Endoscopic Imaging and the Impact of New Technologies on Quality in Colonic Examinations

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Miroslaw Szura · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice. The important elements of this evaluation are: * Evaluation of the character of neoplastic lesions in the colon based on different imaging techniques * Verification of the endoscopic image with histopathologic descriptions * Establishing the type of the lesion on the basis of Kudo and NICE classifications * Comparison of the result of histopathological examination with the macroscopic type of the lesion * Determination of the most advanced lesions (MAL) * Comparison of the cecal intubation time * Evaluation of the type of anesthesia used during colonoscopy * Subjective assessment of the severity of pain according to VAS (visual analogue scale) * Comparison of the accuracy of the location of lesions on the basis of endoscopic navigation * Comparison of the total examination time * Comparison of adenoma detection rate

Detailed description

A total of 400 consecutive patients undergoing unsedated colonoscopy as a part of a national colorectal cancer screening program will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions according. to Kudo and NICE classification. Endoscopic biopsy samples will be taken from all lesions and in vivo endoscopic diagnosis will be compared with final histopathological result. Thus, sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, cecal intubation rate and pain intensity (VAS) will be determined. This study will help to establish whether advanced imaging technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

Conditions

• Polyps
• Neoplasms

Interventions

Type	Name	Description
DEVICE	Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)	NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.
DEVICE	Conventional colonoscopy (Olympus CF-H180DL)	Conventional colonoscopy performed without innovative techniques used in experimental arm.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2018-12-01
• First posted: 2016-10-11
• Last updated: 2016-10-11

Locations

1 site across 1 country: Poland