Inflammatory Bowel DiseasesHELIOSNCT04291976
Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance
A study testing Back-to-back high-definition white light endoscopy, single-pass high-definition white light endoscopy and chromoendoscopy in people with Inflammatory Bowel Diseases and Colorectal Neoplasms, run by Radboud University Medical Center at 4 sites in Netherlands.
Trial summary
The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Colorectal Neoplasms
- What is being tested?
- Back-to-back high-definition white light endoscopy, single-pass high-definition white light endoscopy and chromoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 563 participants
- Where
- 4 sitesNetherlands
- Study dates
- 13 Mar 2020to 7 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis).
- Previous assessable surveillance endoscopy > 1 year
- Age > 18 years
Who cannot join
- Active colitis > 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist.
- Allergy or intolerance to methylene blue
- Insufficient bowel cleansing (BBPS <6)
- Refusing or incapable to agree with informed consent
- Pregnant women
- > 50 % of the colon surgically removed
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Leiden University Medical Center
Leiden, South Holland
Radboudumc
Nijmegen, Gelderland, 6525GA
Utrecht University Medical Center
Utrecht, Gelderland, 3584CX
About this study
Official title: Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light Endoscopy and Chromoendoscopy in IBD Surveillance
The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.
Read the detailed description
The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required.
To demonstrate a superiority of back-to-back HDWLE compared to a regular HDWLE, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. Therefore, the investigators will include 226 patients in group back-to-back HDWLE, 226 in group CE, and 113 patients in group regular HDWLE. This amounts to a total of 560 patients. To account for any screen-failures The investigators will include at most 5% (of 560) additional patients until 80% power is reached.
- Conditions
- Inflammatory Bowel Diseases, Colorectal Neoplasms
- Being tested
- Back-to-back high-definition white light endoscopy, single-pass high-definition white light endoscopy, chromoendoscopy
- Keywords
- IBD, Inflammatory Bowel Diseases, Colorectal Cancer, Surveillance, Dysplasia, Back-to-Back, Chromoendoscopy, White light
- Medical subject headings
- Inflammatory Bowel Diseases, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back-to-back high-definition white light endoscopyProcedure or surgery
Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached, with a second segmental inspection after the first examination in the same session.The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.
single-pass high-definition white light endoscopyProcedure or surgery
Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.
chromoendoscopyProcedure or surgery
After introduction of the endoscope into the colon a dye (methylene blue or indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two interventions.
| Study group | Role | What they receive |
|---|---|---|
| back-to-back HDWLE | Experimental | Similar to single-pass HDWLE, with a second segmental inspection after the first examination in the same session. Equipment is similar to 1. Receives: Procedure: Back-to-back high-definition white light endoscopy |
| single-pass HDWLE | Active comparator | Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution. Receives: Procedure: single-pass high-definition white light endoscopy |
| Chromoendoscopy | Active comparator | After introduction of the endoscope into the colon a dye (methylene blue or 0.3% indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two arms. Receives: Procedure: chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of neoplasia for each technique
Measured: During endoscopy
Secondary outcomes (8)
Number of all lesions for each technique
Measured: During endoscopy
Number of dysplastic lesions for each technique
Measured: After each endoscopy, within one month after the procedure.
Kudo classification for each lesion
Measured: During endoscopy when a lesion is detected
Duration
Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique.
Measured: During endoscopy
Number of targeted biopsies taken in the different groups.
Measured: During endoscopy
Percentage of non-interpretable/assessable endoscopies
e.g. insufficient preparation, inflammation
Measured: During endoscopy
Location of the lesion
Measured: During endoscopy
Size of the lesion in mm
Measured: During endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start13 Mar 2020
- Primary completion23 May 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.
- Masking
- None (open label)
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Sponsor
- Investigators
- Frank Hoentjen, MD PhD, Principal investigator, Radboud University Medical CenterBas Oldenburg, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291976
- Sponsor's protocol ID
- 109344
- Acronym
- HELIOS
- Status last verified
- Nov 2023
- First submitted
- 26 Feb 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light Endoscopy and Chromoendoscopy in IBD Surveillance
- ClinicalTrials.gov ID
- NCT04291976
- Acronym / sponsor ID
- HELIOS / 109344
- Conditions
- Inflammatory Bowel Diseases, Colorectal Neoplasms
- Keywords
- IBD, Inflammatory Bowel Diseases, Colorectal Cancer, Surveillance, Dysplasia, Back-to-Back, Chromoendoscopy, White light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 2 Mar 2020 (actual)
- 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 current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.
Detailed description
The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required.
To demonstrate a superiority of back-to-back HDWLE compared to a regular HDWLE, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. Therefore, the investigators will include 226 patients in group back-to-back HDWLE, 226 in group CE, and 113 patients in group regular HDWLE. This amounts to a total of 560 patients. To account for any screen-failures The investigators will include at most 5% (of 560) additional patients until 80% power is reached.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.
| Arm | Type | Receives |
|---|---|---|
| back-to-back HDWLE | Experimental | Procedure: Back-to-back high-definition white light endoscopySimilar to single-pass HDWLE, with a second segmental inspection after the first examination in the same session. Equipment is similar to 1. |
| single-pass HDWLE | Active comparator | Procedure: single-pass high-definition white light endoscopyUsing HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution. |
| Chromoendoscopy | Active comparator | Procedure: chromoendoscopyAfter introduction of the endoscope into the colon a dye (methylene blue or 0.3% indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis).
- Previous assessable surveillance endoscopy > 1 year
- Age > 18 years
Key exclusion criteria (6 listed)
- Active colitis > 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist.
- Allergy or intolerance to methylene blue
- Insufficient bowel cleansing (BBPS <6)
- Refusing or incapable to agree with informed consent
- Pregnant women
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 |
|---|---|---|
| Back-to-back high-definition white light endoscopyUsing HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached, with a second segmental inspection after the first examination in the same session.The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution. | Procedure or surgery | back-to-back HDWLE |
| single-pass high-definition white light endoscopyUsing HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution. | Procedure or surgery | single-pass HDWLE |
| chromoendoscopyAfter introduction of the endoscope into the colon a dye (methylene blue or indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two interventions. | Procedure or surgery | Chromoendoscopy |
Primary outcome
detection rate of neoplasia for each technique
Time frame: During endoscopy
8 secondary outcomes
Number of all lesions for each technique
Time frame: During endoscopy
Number of dysplastic lesions for each technique
Time frame: After each endoscopy, within one month after the procedure.
Kudo classification for each lesion
Time frame: During endoscopy when a lesion is detected
Duration
Time frame: During endoscopy
Number of targeted biopsies taken in the different groups.
Time frame: During endoscopy
Percentage of non-interpretable/assessable endoscopies
Time frame: During endoscopy
Location of the lesion
Time frame: During endoscopy
Size of the lesion in mm
Time frame: During endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Frank Hoentjen, MD PhD principal investigator
Radboud University Medical Center
Bas Oldenburg, MD PhD principal investigator
UMC Utrecht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back-to-back high-definition white light endoscopy, single-pass high-definition white light endoscopy and chromoendoscopy in people with Inflammatory Bowel Diseases and Colorectal Neoplasms, run by Radboud University Medical Center at 4 sites in Netherlands.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate of neoplasia for each technique (time frame: During endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.