Advanced Endoscopic Imaging in Colonoscopy (AEI)

Miroslaw Szura

Status: Unknown

Conditions: Polyps; Neoplasms

Treatments: Device: Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus); Device: Conventional colonoscopy (Olympus CF-H180DL)

Study type: Interventional

Funder types: Other

Identifiers

NCT02929381

ADVANCED ENDOSCOPIC IMAGING

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated 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
• IBD
• GI neoplastic disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 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-HQ190L, 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)