Advanced Endoscopic Imaging in Colonoscopy

Not Applicable

• Conditions: Polyps; Neoplasms
• Interventions: Device: Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus); Device: Conventional colonoscopy (Olympus CF-H180DL)

• Registration Number: NCT02929381
• Lead Sponsor: Miroslaw Szura

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-30
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-11
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Innovative colonoscopy	Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)	Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus)
Conventional colonoscopy	Conventional colonoscopy (Olympus CF-H180DL)	Conventional colonoscopy performed without innovative techniques assessed in this study.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of innovative colonoscopy	1 year	Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to NICE and Kudo classification during colonoscopy and results will be compared with histologic examination.

Secondary Outcome Measures

Name	Time	Method
Pain intensity (VAS scale)	immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure	Pain intensity will be assessed during and after each colonoscopy using the Visual Analogue Scale. It will be assessed immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure.
Total examination time	8-20 minutes	Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.
Cecal intubation time	5-15 minutes	Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.

Trial Locations

Locations (1)

Specialist Diagnostic and Therapeutic Center MEDICINA; 🇵🇱 Krakow, Malopolska, Poland