Clinical trial NCT01688557: Trial on Innovative Technologies in Colonoscopy
Official title: Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyps
Neoplasms
Inflammatory Bowel Disease
Keywords: narrow band imaging
dual focus
responsive insertion technique
scope guide
colonoscopy
colorectal cancer screening
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Specialist Diagnostic and Therapeutic Center MEDICINA
First posted: 2012-09-20
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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 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

Primary outcomes:
measure: Diagnostic accuracy of innovative colonoscopy
timeFrame: 1 year
Secondary outcomes:
measure: Total examination time
timeFrame: 8-20 minutes
measure: Coecal intubation time
timeFrame: 5-15 minutes
measure: Pain intensity (VAS scale)
timeFrame: 0-10
Other outcomes:
measure: Sensitivity of innovative colonoscopy
timeFrame: 1 year
measure: Specificity of innovative colonoscopy
timeFrame: 1 year
measure: Positive predictive Value (PPV) od innovative colonoscopy
timeFrame: 1 year
measure: Negative predicting value (NPV) of innovative colonoscopy
timeFrame: 1 year
measure: Youden's index for innovative colonoscopy
timeFrame: 1 year
measure: Diagnostic odds ratio (DOR) for innovative colonoscopy
timeFrame: 1 year
measure: Likelihood ratio for positive test results (LR+)
timeFrame: 1 year
measure: Likelihood ratio for negative test results (LR-)
timeFrame: 1 year
measure: Area under the ROC curve (AUC)
timeFrame: 1 year
Locations:
city: Krakow
country: Poland
facility: Specialist Diagnostic and Therapeutic Center MEDICINA
state: Malopolska
city: Krakow
country: Poland
facility: I Department of General Surgery, Jagiellonian University
state: Malopolska
Study officials:
affiliation: I Department of General Surgery, Jagiellonian University
name: Miroslaw Szura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: I Department of General Surgery, Jagiellonian University
name: Radoslaw Pach, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Pasternak A, Szura M, Solecki R, Matyja M, Szczepanik A, Matyja A. Impact of responsive insertion technology (RIT) on reducing discomfort during colonoscopy: randomized clinical trial. Surg Endosc. 2017 May;31(5):2247-2254. doi: 10.1007/s00464-016-5226-x. Epub 2016 Sep 8.
citation: Szura M, Pasternak A, Solecki R, Matyja M, Szczepanik A, Matyja A. Accuracy of preoperative tumor localization in large bowel using 3D magnetic endoscopic imaging: randomized clinical trial. Surg Endosc. 2017 May;31(5):2089-2095. doi: 10.1007/s00464-016-5203-4. Epub 2016 Aug 29.