Trial on Innovative Technologies in Colonoscopy (RCT-IC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Jagiellonian University
Sponsor:
Collaborator:
Specialist Diagnostic and Therapeutic Center MEDICINA
Information provided by (Responsible Party):
Miroslaw Szura, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01688557
First received: September 16, 2012
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

The trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination.

  • Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band imaging (NBI) will be used for innovative colonoscopies
  • Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used for conventional colonoscopies Endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. All endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological lesions will be performed to establish final diagnosis. The main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.

Condition Intervention
Polyps
Neoplasms
Inflammatory Bowel Disease
Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)
Device: Conventional colonoscopy (Olympus CF-H180DL)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • Diagnostic accuracy of innovative colonoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Sano and Kudo classification during colonoscopy and results will be compared with histologic examination.


Secondary Outcome Measures:
  • Total examination time [ Time Frame: 8-20 minutes ] [ Designated as safety issue: No ]
    Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.

  • Coecal intubation time [ Time Frame: 5-15 minutes ] [ Designated as safety issue: No ]
    Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.

  • Pain intensity (VAS scale) [ Time Frame: 0-10 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Sensitivity of innovative colonoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.

  • Specificity of innovative colonoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.

  • Positive predictive Value (PPV) od innovative colonoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.

  • Negative predicting value (NPV) of innovative colonoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.

  • Youden's index for innovative colonoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.

  • Diagnostic odds ratio (DOR) for innovative colonoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.

  • Likelihood ratio for positive test results (LR+) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.

  • Likelihood ratio for negative test results (LR-) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.

  • Area under the ROC curve (AUC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software.


Estimated Enrollment: 600
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Innovative colonoscopy
Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).
Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)
NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.
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.

Detailed Description:

A total of 600 consecutive patients undergoing screening unsedated colonoscopy 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 acc. to Sano and Kudo classification. Endoscopic biopsy will be taken from all lesion and endoscopic diagnosis will be compared with final histological diagnosis. Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, coecal intubation rate and pain intensity (VAS scale) will be established. This study will help to establish whether new technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688557

Contacts
Contact: Miroslaw Szura, MD, PhD 4248007 ext +4812 miroslaw.szura@uj.edu.pl
Contact: Radoslaw Pach, MD, PhD 4248009 ext +4812 radoslaw.pach@uj.edu.pl

Locations
Poland
I Department of General Surgery, Jagiellonian University Recruiting
Krakow, Malopolska, Poland, 31-501
Principal Investigator: Miroslaw Szura, MD, PhD         
Sub-Investigator: Radoslaw Pach, MD, PhD         
Sub-Investigator: Rafal Solecki, MD, PhD         
Specialist Diagnostic and Therapeutic Center MEDICINA Recruiting
Krakow, Malopolska, Poland, 30-307
Principal Investigator: Miroslaw Szura, MD, PhD         
Sub-Investigator: Rafal Solecki, MD, PhD         
Sub-Investigator: Radoslaw Pach, MD, PhD         
Sponsors and Collaborators
Jagiellonian University
Specialist Diagnostic and Therapeutic Center MEDICINA
Investigators
Principal Investigator: Miroslaw Szura, MD, PhD I Department of General Surgery, Jagiellonian University
Study Chair: Radoslaw Pach, MD, PhD I Department of General Surgery, Jagiellonian University
  More Information

Additional Information:
No publications provided

Responsible Party: Miroslaw Szura, Assisstant Professor, Jagiellonian University
ClinicalTrials.gov Identifier: NCT01688557     History of Changes
Other Study ID Numbers: Innovations in colonoscopy
Study First Received: September 16, 2012
Last Updated: September 19, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
narrow band imaging
dual focus
responsive insertion technique
scope guide
colonoscopy
colorectal cancer screening

Additional relevant MeSH terms:
Neoplasms
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 09, 2014