Ulcerative ColitisSUNRISE-HighNCT04257084
Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
A study testing chromoendoscopy with target biopsy; NBI with target biopsy in people with Ulcerative Colitis and Dysplasia, run by Asan Medical Center.
Trial summary
The risk of colorectal cancer (CRC) is increased in patients having ulcerative colitis (UC). Patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of CRC and require regular and short-interval surveillance… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Ulcerative Colitis, Dysplasia
- What is being tested?
- chromoendoscopy with target biopsy; NBI with target biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jan 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one of the followings should be satisfied;
- A patient having extensive ulcerative colitis with 8-year or longer disease duration
- A patient having both ulcerative colitis and primary sclerosing colitis
- A patient having a previous history of dysplasia at the colitic segment within recent 5 years
Who cannot join
- All of the following conditions should be excluded for 1st surveillance colonoscopy study
- A patient who underwent total or segment colectomy.
- A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
- A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
- A patient who has a coagulopathy
- A patient who has chronic renal disease evidenced by serum creatinine > 1.2 mg/dL within 6 months of study participation
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- A patient who has already undergone surveillance colonoscopy within 1 year
- All of the following conditions should be excluded for 2nd surveillance colonoscopy study even if they were included in 1st surveillance study.
- A patient who underwent total or segment colectomy after 1st surveillance colonoscopy for this trial.
- A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
- A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
- A patient who has a coagulopathy
- A patient who has chronic renal disease evidenced by serum creatinine > 1.2 mg/dL within 6 months of study participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized Controlled Trial for Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
The risk of colorectal cancer (CRC) is increased in patients having ulcerative colitis (UC). Patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of CRC and require regular and short-interval surveillance colonoscopy. Recent guidelines recommend surveillance colonoscopy based on target biopsy rather than random biopsy applying chromoendoscopy (CE) or narrow band image (NBI) technique in UC at risk for CRC. However, the diagnostic yield of NBI-based surveillance and CE-based surveillance is not extensively investigated in the high-risk UC population. The investigators aimed to compare the dysplasia detection rate of NBI with that of CE in UC patients with a high risk of CRC by performing a multicenter, randomized controlled trial.
- Conditions
- Ulcerative Colitis, Dysplasia
- Being tested
- chromoendoscopy with target biopsy; NBI with target biopsy
- Keywords
- chromoendoscopy, narrow band image, surveillance
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chromoendoscopy with target biopsy; NBI with target biopsyDiagnostic test
Chromoendoscopy with target biopsy: 0.03% indigo carmine solution based chromoendoscopy (using high-definition colonoscopy) will be fulfilled and target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia.
NBI with target biopsy: After inserting a high definition colonoscopy up to cecum, endoscopists observe the colon in combination of white light and NBI (white light first and then NBI). Target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia.
| Study group | Role | What they receive |
|---|---|---|
| CE-NBI | Active comparator | High definition chromoendoscopy with target biopsy, at 1st surveillance colonoscopy during the trial High definition NBI with target biopsy, at 2nd surveillance colonoscopy during the trial Receives: Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsy |
| NBI-CE | Active comparator | High definition NBI with target biopsy, at 1st surveillance colonoscopy during the trial High definition chromoendoscopy with target biopsy, at 2nd surveillance colonoscopy during the trial Receives: Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysplasia detection rate at first surveillance
Any dysplasia within the colitic segments will be counted as "dysplasia" to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as "dysplasia", but SSLs without dysplasia will not be counted as "dysplasia" even if located within colitic segments.
Measured: 3 months after first surveillance colonoscopy in each arm
Neoplasia detection rate at first surveillance
Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia
Measured: 3 months after first surveillance colonoscopy in each arm
Dysplasia detection rate at second surveillance
Any dysplasia within the colitic segments will be counted as "dysplasia" to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as "dysplasia", but SSLs without dysplasia will not be counted as "dysplasia" even if located within colitic segments.
Measured: 3 months after second surveillance colonoscopy in each arm
Neoplasia detection rate at second surveillance
Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia
Measured: 3 months after second surveillance colonoscopy in each arm
Secondary outcomes (5)
SSL detection rate
Whether located at colitic or non-colitic segments, SSL will be included for calculating SSL detection rate in each arm. Serrated epithelial changes (serrated epithelial changes in histology, but nor discrete border under colonoscopy or no dysplasia under microscopy) will not be considered as SSL.
Measured: 3 months after overall surveillance colonoscopy in each arm
Total procedure time
The whole colonoscopy procedure time
Measured: 3 months after overall surveillance colonoscopy in each arm
Withdrawal time
Time spent for withdrawal after excluding time for taking biopsies
Measured: 3 months after overall surveillance colonoscopy in each arm
Endoscopic features of target-biopsied lesions
Pit and vascular patterns, Modified Paris classification (suggested by SCENIC group)
Measured: 3 months after overall surveillance colonoscopy in each arm
Procedure-related adverse events
bleeding requiring hemostasis or transfusion, perforation, exacerbation of UC requiring admission (within 3 months after surveillance colonoscopy)
Measured: 3 months after overall surveillance colonoscopy in each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startDec 2020 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- a randomized controlled crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yonsei University, Samsung Medical Center, Sungkyunkwan University, Ewha Womans University, The Catholic University of Korea, Soonchunhyang University Hospital
- Responsible party
- Principal investigator, Dong-Hoon Yang, Asan Medical Center
- Investigators
- Dong-Hoon Yang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257084
- Sponsor's protocol ID
- SUNRISE-High
- Acronym
- SUNRISE-High
- Status last verified
- Nov 2020
- First submitted
- 2 Feb 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial for Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
- ClinicalTrials.gov ID
- NCT04257084
- Acronym / sponsor ID
- SUNRISE-High / SUNRISE-High
- Conditions
- Ulcerative Colitis, Dysplasia
- Keywords
- chromoendoscopy, narrow band image, surveillance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Yonsei University, Samsung Medical Center, Sungkyunkwan University, Ewha Womans University, The Catholic University of Korea, Soonchunhyang University Hospital
- Study start
- Dec 2020 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 5 Feb 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 risk of colorectal cancer (CRC) is increased in patients having ulcerative colitis (UC). Patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of CRC and require regular and short-interval surveillance colonoscopy. Recent guidelines recommend surveillance colonoscopy based on target biopsy rather than random biopsy applying chromoendoscopy (CE) or narrow band image (NBI) technique in UC at risk for CRC. However, the diagnostic yield of NBI-based surveillance and CE-based surveillance is not extensively investigated in the high-risk UC population. The investigators aimed to compare the dysplasia detection rate of NBI with that of CE in UC patients with a high risk of CRC by performing a multicenter, randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a randomized controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| CE-NBI | Active comparator | Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsyHigh definition chromoendoscopy with target biopsy, at 1st surveillance colonoscopy during the trial High definition NBI with target biopsy, at 2nd surveillance colonoscopy during the trial |
| NBI-CE | Active comparator | Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsyHigh definition NBI with target biopsy, at 1st surveillance colonoscopy during the trial High definition chromoendoscopy with target biopsy, at 2nd surveillance colonoscopy during the trial |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least one of the followings should be satisfied;
Key exclusion criteria (13 listed)
- All of the following conditions should be excluded for 1st surveillance colonoscopy study
- All of the following conditions should be excluded for 2nd surveillance colonoscopy study even if they were included in 1st surveillance study.
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 |
|---|---|---|
| chromoendoscopy with target biopsy; NBI with target biopsyChromoendoscopy with target biopsy: 0.03% indigo carmine solution based chromoendoscopy (using high-definition colonoscopy) will be fulfilled and target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia. NBI with target biopsy: After inserting a high definition colonoscopy up to cecum, endoscopists observe the colon in combination of white light and NBI (white light first and then NBI). Target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia. | Diagnostic test | CE-NBI, NBI-CE |
Primary outcome
Dysplasia detection rate at first surveillance
Time frame: 3 months after first surveillance colonoscopy in each arm
Any dysplasia within the colitic segments will be counted as "dysplasia" to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as "dysplasia", but SSLs without dysplasia will not be counted as "dysplasia" even if located within colitic segments.
Neoplasia detection rate at first surveillance
Time frame: 3 months after first surveillance colonoscopy in each arm
Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia
Dysplasia detection rate at second surveillance
Time frame: 3 months after second surveillance colonoscopy in each arm
Any dysplasia within the colitic segments will be counted as "dysplasia" to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as "dysplasia", but SSLs without dysplasia will not be counted as "dysplasia" even if located within colitic segments.
Neoplasia detection rate at second surveillance
Time frame: 3 months after second surveillance colonoscopy in each arm
Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia
5 secondary outcomes
SSL detection rate
Time frame: 3 months after overall surveillance colonoscopy in each arm
Total procedure time
Time frame: 3 months after overall surveillance colonoscopy in each arm
Withdrawal time
Time frame: 3 months after overall surveillance colonoscopy in each arm
Endoscopic features of target-biopsied lesions
Time frame: 3 months after overall surveillance colonoscopy in each arm
Procedure-related adverse events
Time frame: 3 months after overall surveillance colonoscopy in each arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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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.
Dong-Hoon Yang, MD, PhD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing chromoendoscopy with target biopsy; NBI with target biopsy in people with Ulcerative Colitis and Dysplasia, run by Asan Medical Center.
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 13 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Dong-Hoon Yang, MD, PhD (82-2-3010-5809, dhyang@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysplasia detection rate at first surveillance (time frame: 3 months after first surveillance colonoscopy in each arm). The study lists 4 primary outcomes in all. 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 24 Nov 2020.