Advanced Endoscopic Imaging in Colonoscopy (AEI)

October 7, 2016 updated by: Miroslaw Szura

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 30-307
        • Recruiting
        • Specialist Diagnostic and Therapeutic Center MEDICINA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafal Solecki, MD, PhD
        • Principal Investigator:
          • Artur Pasternak, MD, PhD
        • Principal Investigator:
          • Michal Zelek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional colonoscopy
Conventional colonoscopy performed without innovative techniques assessed in this study.
Device: Conventional colonoscopy (Olympus CF-H180DL)
Conventional colonoscopy performed without innovative techniques used in experimental arm.
Experimental: Innovative colonoscopy
Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of innovative colonoscopy
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total examination time
Time Frame: 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.
8-20 minutes
Cecal intubation time
Time Frame: 5-15 minutes
Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.
5-15 minutes
Pain intensity (VAS scale)
Time Frame: 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.
immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miroslaw Szura

Collaborators

Jagiellonian University
Specialist Diagnostic and Therapeutic Center MEDICINA

Investigators

  • Principal Investigator: Miroslaw Szura, MD, PhD, Department of Experimental and Clinical Surgery, Jagiellonian University Medical College,
  • Study Chair: Artur Pasternak, MD, PhD, Department of Anatomy, Jagiellonian University Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ADVANCED ENDOSCOPIC IMAGING

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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