Clinical trial NCT02929381: Advanced Endoscopic Imaging in Colonoscopy
Official title: A Prospective Randomized Clinical Trial to Assess the Utility of Advanced Endoscopic Imaging and the Impact of New Technologies on Quality in Colonic Examinations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyps
Neoplasms
Keywords: Narrow Band Imaging
Colorectal Cancer Screening
Colonoscopy
Responsive Insertion Technology
Near Focus
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Specialist Diagnostic and Therapeutic Center MEDICINA
name: Jagiellonian University
First posted: 2016-10-11
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* no previous abdominal surgery
* no colonoscopy during last 10 years

Exclusion Criteria:

* age \< 40 and \> 65 years
* large bowel resection in history
* colonoscopy performed during last 10 years
* contraindications for general anaesthesia
* ASA \> IV
* pregnancy
* confirmed neoplastic disease
* cirrhosis (Child B or C) or ascites
* immunosuppressive therapy or steroids intake
* malabsorption syndrome
* IBD
* GI neoplastic disease

Primary outcomes:
measure: Diagnostic accuracy of innovative colonoscopy
timeFrame: 1 year
Secondary outcomes:
measure: Total examination time
timeFrame: 8-20 minutes
measure: Cecal intubation time
timeFrame: 5-15 minutes
measure: Pain intensity (VAS scale)
timeFrame: immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Specialist Diagnostic and Therapeutic Center MEDICINA
state: Malopolska
Study officials:
affiliation: Department of Experimental and Clinical Surgery, Jagiellonian University Medical College,
name: Miroslaw Szura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anatomy, Jagiellonian University Medical College
name: Artur Pasternak, MD, PhD
role: STUDY_CHAIR
References:
citation: Bogacki P, Gach T, Krzak J, Szura M. Panoramic colonoscopy in colorectal cancer screening - a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2021 Jun;16(2):289-296. doi: 10.5114/wiitm.2021.103922. Epub 2021 Feb 25.