Trial on Innovative Technologies in Colonoscopy

Neoplasms Clinical Trial

— RCT-IC  

Official title:

Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688557
• Other study ID #: Innovations in colonoscopy
• Status: Completed
• Phase: N/A
• First received: September 16, 2012
• Last updated: October 6, 2016
• Start date: September 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• 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

Study Design

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Neoplasms
• Polyps

Intervention

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

Locations

Country	Name	City	State
Poland	I Department of General Surgery, Jagiellonian University	Krakow	Malopolska
Poland	Specialist Diagnostic and Therapeutic Center MEDICINA	Krakow	Malopolska

Sponsors (2)

Lead Sponsor	Collaborator
Jagiellonian University	Specialist Diagnostic and Therapeutic Center MEDICINA

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Szura M, Pasternak A, Bucki K, Urbanczyk K, Matyja A. Two-stage optical system for colorectal polyp assessments. Surg Endosc. 2016 Jan;30(1):204-14. doi: 10.1007/s00464-015-4186-x. Epub 2015 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity of innovative colonoscopy	The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.	1 year	No
Other	Specificity of innovative colonoscopy	The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.	1 year	No
Other	Positive predictive Value (PPV) od innovative colonoscopy	The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.	1 year	No
Other	Negative predicting value (NPV) of innovative colonoscopy	The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.	1 year	No
Other	Youden's index for innovative colonoscopy	The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.	1 year	No
Other	Diagnostic odds ratio (DOR) for innovative colonoscopy	The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.	1 year	No
Other	Likelihood ratio for positive test results (LR+)	The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.	1 year	No
Other	Likelihood ratio for negative test results (LR-)	The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.	1 year	No
Other	Area under the ROC curve (AUC)	Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software.	1 year	No
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 Sano 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	Coecal 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.	0-10	No

External Links

•   The official site of Specialist Diagnostic and Therapeutic Center MEDICINA
•   The official site of the I Department of General Surgery, Jagiellonian University