PolypsAEINCT02929381
Advanced Endoscopic Imaging in Colonoscopy
A study testing Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus) and Conventional colonoscopy (Olympus CF-H180DL) in people with Polyps and Neoplasms, run by Miroslaw Szura at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- What is being tested?
- Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus) and Conventional colonoscopy (Olympus CF-H180DL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- no previous abdominal surgery
- no colonoscopy during last 10 years
Who cannot join
- age < 40 and > 65 years
- large bowel resection in history
- colonoscopy performed during last 10 years
- contraindications for general anaesthesia
- ASA > IV
- pregnancy
Show all 12Show fewer
- confirmed neoplastic disease
- cirrhosis (Child B or C) or ascites
- immunosuppressive therapy or steroids intake
- malabsorption syndrome
- IBD
- GI neoplastic disease
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Specialist Diagnostic and Therapeutic Center MEDICINA
Krakow, Malopolska, 30-307
Miroslaw Szura, Md, PhD, 609210030 ext. +48, msszura@gmail.com
Artur Pasternak, MD, PhD, 603642620 ext. +48, artur.pasternak@uj.edu.pl
About this study
Official title: A Prospective Randomized Clinical Trial to Assess the Utility of Advanced Endoscopic Imaging and the Impact of New Technologies on Quality in Colonic Examinations
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
Read the detailed 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.
- Being tested
- Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus), Conventional colonoscopy (Olympus CF-H180DL)
- Keywords
- Narrow Band Imaging, Colorectal Cancer Screening, Colonoscopy, Responsive Insertion Technology, Near Focus
- Medical subject headings
- Polyps, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)Device
NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.
Conventional colonoscopy (Olympus CF-H180DL)Device
Conventional colonoscopy performed without innovative techniques used in experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Innovative colonoscopy | Experimental | Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus) Receives: Device: Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus) |
| Conventional colonoscopy | Active comparator | Conventional colonoscopy performed without innovative techniques assessed in this study. Receives: Device: Conventional colonoscopy (Olympus CF-H180DL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 NICE and Kudo classification during colonoscopy and results will be compared with histologic examination.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 8-20 minutes
Cecal intubation time
Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.
Measured: 5-15 minutes
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.
Measured: immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miroslaw Szura
- Sponsor type
- University, hospital or other
- Collaborators
- Specialist Diagnostic and Therapeutic Center MEDICINA, Jagiellonian University
- Responsible party
- Sponsor-investigator, Miroslaw Szura, Jagiellonian University
- Investigators
- Miroslaw Szura, MD, PhD, Principal investigator, Department of Experimental and Clinical Surgery, Jagiellonian University Medical College,Artur Pasternak, MD, PhD, Study chair, Department of Anatomy, Jagiellonian University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929381
- Sponsor's protocol ID
- ADVANCED ENDOSCOPIC IMAGING
- Acronym
- AEI
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34136023
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial to Assess the Utility of Advanced Endoscopic Imaging and the Impact of New Technologies on Quality in Colonic Examinations
- ClinicalTrials.gov ID
- NCT02929381
- Acronym / sponsor ID
- AEI / ADVANCED ENDOSCOPIC IMAGING
- Keywords
- Narrow Band Imaging, Colorectal Cancer Screening, Colonoscopy, Responsive Insertion Technology, Near Focus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Miroslaw SzuraUniversity, hospital or other
- Collaborators
- Specialist Diagnostic and Therapeutic Center MEDICINA, Jagiellonian University
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative colonoscopy | Experimental | Device: Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus) |
| Conventional colonoscopy | Active comparator | Device: Conventional colonoscopy (Olympus CF-H180DL)Conventional colonoscopy performed without innovative techniques assessed in this study. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- no previous abdominal surgery
- no colonoscopy during last 10 years
Key exclusion criteria (12 listed)
- age < 40 and > 65 years
- large bowel resection in history
- colonoscopy performed during last 10 years
- contraindications for general anaesthesia
- ASA > IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Innovative colonoscopy |
| Conventional colonoscopy (Olympus CF-H180DL)Conventional colonoscopy performed without innovative techniques used in experimental arm. | Device | Conventional colonoscopy |
Primary outcome
Diagnostic accuracy of innovative colonoscopy
Time frame: 1 year
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 NICE and Kudo classification during colonoscopy and results will be compared with histologic examination.
3 secondary outcomes
Total examination time
Time frame: 8-20 minutes
Cecal intubation time
Time frame: 5-15 minutes
Pain intensity (VAS scale)
Time frame: immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 34136023Bogacki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslaw Szura, MD, PhD principal investigator
Department of Experimental and Clinical Surgery, Jagiellonian University Medical College,
Artur Pasternak, MD, PhD study chair
Department of Anatomy, Jagiellonian University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus) and Conventional colonoscopy (Olympus CF-H180DL) in people with Polyps and Neoplasms, run by Miroslaw Szura at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miroslaw Szura, MD, PhD (609210030, msszura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of innovative colonoscopy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.