Advanced Endoscopic Imaging in Colonoscopy

NCT ID: NCT02929381

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Polyps Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Innovative colonoscopy

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

Group Type EXPERIMENTAL

Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)

Intervention Type DEVICE

NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.

Conventional colonoscopy

Conventional colonoscopy performed without innovative techniques assessed in this study.

Group Type ACTIVE_COMPARATOR

Conventional colonoscopy (Olympus CF-H180DL)

Intervention Type DEVICE

Conventional colonoscopy performed without innovative techniques used in experimental arm.

Interventions

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Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)

NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.

Intervention Type DEVICE

Conventional colonoscopy (Olympus CF-H180DL)

Conventional colonoscopy performed without innovative techniques used in experimental arm.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Specialist Diagnostic and Therapeutic Center MEDICINA

UNKNOWN

Sponsor Role collaborator

Jagiellonian University

OTHER

Sponsor Role collaborator

Miroslaw Szura

OTHER

Sponsor Role lead

Responsible Party

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Miroslaw Szura

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Miroslaw Szura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Experimental and Clinical Surgery, Jagiellonian University Medical College,

Artur Pasternak, MD, PhD

Role: STUDY_CHAIR

Department of Anatomy, Jagiellonian University Medical College

Locations

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Specialist Diagnostic and Therapeutic Center MEDICINA

Krakow, Malopolska, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Miroslaw Szura, MD, PhD

Role: CONTACT

609210030

Artur Pasternak, MD, PhD

Role: CONTACT

603642620

Facility Contacts

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Miroslaw Szura, Md, PhD

Role: primary

609210030 ext. +48

Artur Pasternak, MD, PhD

Role: backup

603642620 ext. +48

References

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Bogacki P, Gach T, Krzak J, Szura M. Panoramic colonoscopy in colorectal cancer screening - a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2021 Jun;16(2):289-296. doi: 10.5114/wiitm.2021.103922. Epub 2021 Feb 25.

Reference Type DERIVED
PMID: 34136023 (View on PubMed)

Other Identifiers

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ADVANCED ENDOSCOPIC IMAGING

Identifier Type: -

Identifier Source: org_study_id

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