Trial on Innovative Technologies in Colonoscopy (RCT-IC)

Jagiellonian University

Status: Completed

Conditions: Polyps; Inflammatory Bowel Disease; Neoplasms

Treatments: Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus); Device: Conventional colonoscopy (Olympus CF-H180DL)

Study type: Interventional

Funder types: Other

Identifiers

NCT01688557

Innovations in colonoscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 2 patient groups

Innovative colonoscopy

Experimental group

Description:

Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).

Treatment:

Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)

Conventional colonoscopy

Active Comparator group

Description:

Conventional colonoscopy performed without innovative techniques assessed in this study.

Treatment:

Device: Conventional colonoscopy (Olympus CF-H180DL)