Advanced Endoscopic Imaging in Colonoscopy

Neoplasms Clinical Trial

— AEI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929381
• Other study ID #: ADVANCED ENDOSCOPIC IMAGING
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2016
• Last updated: October 7, 2016
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Jagiellonian University
• Contact: Miroslaw Szura, MD, PhD
• Phone: 609210030
• Email: msszura[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Neoplasms
• Polyps

Intervention

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.
• Conventional colonoscopy (Olympus CF-H180DL)
Conventional colonoscopy performed without innovative techniques used in experimental arm.

Locations

Country	Name	City	State
Poland	Specialist Diagnostic and Therapeutic Center MEDICINA	Krakow	Malopolska

Sponsors (3)

Lead Sponsor	Collaborator
Miroslaw Szura	Jagiellonian University Medical College, Specialist Diagnostic and Therapeutic Center MEDICINA

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of innovative colonoscopy	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.	1 year	No
Secondary	Total examination time	Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.	8-20 minutes	No
Secondary	Cecal intubation time	Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.	5-15 minutes	No
Secondary	Pain intensity (VAS scale)	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.	immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure	No