Inflammatory Bowel DiseasesNCT04191655
High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)
A study testing High Definition Colonoscopy and Dye Spraying Chromocolonoscopy in people with Inflammatory Bowel Diseases and Colon Dysplasia, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Colon Dysplasia, Ulcerative Colitis
- What is being tested?
- High Definition Colonoscopy and Dye Spraying Chromocolonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2019to 1 Jan 2024
- 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
- Patient age ≥18yr old
- History of UC or colonic Crohn's disease or unclassified colitis patients with or without colonic adenoma history
- Duration of ≥ eight years since diagnosis, or any duration with a diagnosis of primary sclerosing cholangitis
- Mucosal lesion involves ≥ 1/3 of the colon
Who cannot join
- History of colorectal cancer
- History of total colectomy
- Prior colonoscopy within the last 6 months
- Allergy to dye spray
- Poor bowel preparation
- Unable to provide informed consent
- Severe inflammation preventing visualization of the mucosa during the procedure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01803
About this study
Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy.
This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.
Read the detailed description
Research Question:
Is High Definition White Light Colonoscopy (HDWLC) not inferior to Dye Spraying Chromo-colonoscopy (DSC) in detecting all neoplastic lesions during screening patients with colonic IBD for more than eight years?
Study setting: The study will be conducted at Beth Israel Deaconess Medical Center. Patients will be randomized to HDWLC with biopsies every 10 cm versus DSC.
Study population: Adult patients colonic IBD for more than eight years.
Recruitment The study team will conduct a day by day chart review for all patients with a history of inflammatory bowel disease who were scheduled for screening colonoscopy and find candidates who meet the eligibility criteria. A study team member will meet with the potential candidates during their visit to the gastroenterology procedure room before having their colonoscopy and offer them to participate in the study.
Procedures: Participants will undergo either HDWLC with biopsies every 10 cm or DSC based on the randomization. Both procedures are standard of care and are being done at BIDMC before starting this study. All the endoscopists are IBD specialists with expertise in both procedures. All physicians were given a review article and video of chromoendoscopy to further standardize practice. The clinicians who are conducting the HDWLC are allowed to do a targeted DSC if required as per hospital protocol. Both arms of the study are using high definition Olympus colonoscopes
Study design: A randomized controlled, noninferiority trial.
Sample size:
Existing literatures suggest that the detection rate of the DSC arm is 20%. The investigators set 10% as the non-inferiority margin. With a total of 400 subjects (200 in each arm), the study will have 80% power to detect non-inferiority with the type I error rate controlled at 0.05. To account for a potential 25% data attribution, the study team will enroll 500 subjects.
Statistical Analysis:
The baseline characteristics of the two trial arms will first be tabulated for potential imbalance in variables. Continuous variables will be summarized by typical parameters such as mean, standard deviation and range and compared using two-sample T-test (if the normality assumption holds) or Wilcoxon rank-sum test (if the normality assumption does not hold). Normality of distribution will be determined using the Kolmogorov-Smirnov goodness-of-fit test. Categorical data will be summarized by frequency and percentage and analyzed using the Chi-square or Fishers exact test, as appropriate.
The primary outcome will be compared using Z-test based on normal approximation of the sample proportions.
Outcome analysis:
Primary outcome analysis: Intention to treat Secondary outcome analysis: Per protocol analysis.
- Conditions
- Inflammatory Bowel Diseases, Colon Dysplasia, Ulcerative Colitis, Crohn Colitis, Indeterminate Colitis
- Being tested
- High Definition Colonoscopy, Dye Spraying Chromocolonoscopy
- Keywords
- Colorectal cancer screening, Inflammatory bowel disease, Chromocolonoscopy, High definition white light colonoscopy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Definition ColonoscopyDevice
A colonoscopy that used high definition (HD) camera
Dye Spraying ChromocolonoscopyDevice
A colonoscopy that used high definition camera in addition to dye spraying on the interior colon surface.
| Study group | Role | What they receive |
|---|---|---|
| High Definition White Light Colonoscopy | Experimental | Not described Receives: Device: High Definition Colonoscopy |
| Dye Spraying Chromo-colonoscopy | Active comparator | Not described Receives: Device: Dye Spraying Chromocolonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy
Measured: Immediately after the procedure
Secondary outcomes (7)
Detection rate of Adenoma in both groups.
Measured: Immediately after the procedure
Detection rate of high-grade dysplasia in both groups.
Measured: Immediately after the procedure
Numbers of detected adenomas per patient.
Measured: Immediately after the procedure
Difference in withdrawal time to perform the procedure in both groups.
Measured: Immediately after the procedure
Difference in adverse event, mild (e.g.; nausea, vomiting, or abdominal pain that necessitate phone call from the patient to the provider, or sever (e.g.; GI bleeding, perforation, hospitalization after the procedure) for each arm.
Measured: Within one week from the procedure date
Number of targeted chromoendoscopies
Measured: Immediately after the procedure
Appropriateness of reported follow up recommendations per standard guideline recommendations
Measured: Immediately 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 posted10 Dec 2019
- Study start3 Apr 2019
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
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.
- More trials run by Beth Israel Deaconess 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After patients consent to participate to the study, they will be randomized 1:1 by one of the study members who is blinded to the patient's history to either High Definition White Light Colonoscopy with biopsies every 10 cm or Dye Spraying Chromocolonoscopy. The gastroenterologist will be informed about the randomization result and s/he will conduct the procedure.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Feuerstein, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191655
- Sponsor's protocol ID
- 2018P000795
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2019
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT04191655
- Acronym / sponsor ID
- 2018P000795
- Conditions
- Inflammatory Bowel Diseases, Colon Dysplasia, Ulcerative Colitis, Crohn Colitis, Indeterminate Colitis
- Keywords
- Colorectal cancer screening, Inflammatory bowel disease, Chromocolonoscopy, High definition white light colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 10 Dec 2019 (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.
Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy.
This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.
Detailed description
Research Question:
Is High Definition White Light Colonoscopy (HDWLC) not inferior to Dye Spraying Chromo-colonoscopy (DSC) in detecting all neoplastic lesions during screening patients with colonic IBD for more than eight years?
Study setting: The study will be conducted at Beth Israel Deaconess Medical Center. Patients will be randomized to HDWLC with biopsies every 10 cm versus DSC.
Study population: Adult patients colonic IBD for more than eight years.
Recruitment The study team will conduct a day by day chart review for all patients with a history of inflammatory bowel disease who were scheduled for screening colonoscopy and find candidates who meet the eligibility criteria. A study team member will meet with the potential candidates during their visit to the gastroenterology procedure room before having their colonoscopy and offer them to participate in the study.
Procedures: Participants will undergo either HDWLC with biopsies every 10 cm or DSC based on the randomization. Both procedures are standard of care and are being done at BIDMC before starting this study. All the endoscopists are IBD specialists with expertise in both procedures. All physicians were given a review article and video of chromoendoscopy to further standardize practice. The clinicians who are conducting the HDWLC are allowed to do a targeted DSC if required as per hospital protocol. Both arms of the study are using high definition Olympus colonoscopes
Study design: A randomized controlled, noninferiority trial.
Sample size:
Existing literatures suggest that the detection rate of the DSC arm is 20%. The investigators set 10% as the non-inferiority margin. With a total of 400 subjects (200 in each arm), the study will have 80% power to detect non-inferiority with the type I error rate controlled at 0.05. To account for a potential 25% data attribution, the study team will enroll 500 subjects.
Statistical Analysis:
The baseline characteristics of the two trial arms will first be tabulated for potential imbalance in variables. Continuous variables will be summarized by typical parameters such as mean, standard deviation and range and compared using two-sample T-test (if the normality assumption holds) or Wilcoxon rank-sum test (if the normality assumption does not hold). Normality of distribution will be determined using the Kolmogorov-Smirnov goodness-of-fit test. Categorical data will be summarized by frequency and percentage and analyzed using the Chi-square or Fishers exact test, as appropriate.
The primary outcome will be compared using Z-test based on normal approximation of the sample proportions.
Outcome analysis:
Primary outcome analysis: Intention to treat Secondary outcome analysis: Per protocol analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- After patients consent to participate to the study, they will be randomized 1:1 by one of the study members who is blinded to the patient's history to either High Definition White Light Colonoscopy with biopsies every 10 cm or Dye Spraying Chromocolonoscopy. The gastroenterologist will be informed about the randomization result and s/he will conduct the procedure.
| Arm | Type | Receives |
|---|---|---|
| High Definition White Light Colonoscopy | Experimental | Device: High Definition Colonoscopy |
| Dye Spraying Chromo-colonoscopy | Active comparator | Device: Dye Spraying Chromocolonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age ≥18yr old
- History of UC or colonic Crohn's disease or unclassified colitis patients with or without colonic adenoma history
- Duration of ≥ eight years since diagnosis, or any duration with a diagnosis of primary sclerosing cholangitis
- Mucosal lesion involves ≥ 1/3 of the colon
Key exclusion criteria (7 listed)
- History of colorectal cancer
- History of total colectomy
- Prior colonoscopy within the last 6 months
- Allergy to dye spray
- Poor bowel preparation
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 |
|---|---|---|
| High Definition ColonoscopyA colonoscopy that used high definition (HD) camera | Device | High Definition White Light Colonoscopy |
| Dye Spraying ChromocolonoscopyA colonoscopy that used high definition camera in addition to dye spraying on the interior colon surface. | Device | Dye Spraying Chromo-colonoscopy |
Primary outcome
Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy
Time frame: Immediately after the procedure
7 secondary outcomes
Detection rate of Adenoma in both groups.
Time frame: Immediately after the procedure
Detection rate of high-grade dysplasia in both groups.
Time frame: Immediately after the procedure
Numbers of detected adenomas per patient.
Time frame: Immediately after the procedure
Difference in withdrawal time to perform the procedure in both groups.
Time frame: Immediately after the procedure
Difference in adverse event, mild (e.g.; nausea, vomiting, or abdominal pain that necessitate phone call from the patient to the provider, or sever (e.g.; GI bleeding, perforation, hospitalization after the procedure) for each arm.
Time frame: Within one week from the procedure date
Number of targeted chromoendoscopies
Time frame: Immediately after the procedure
Appropriateness of reported follow up recommendations per standard guideline recommendations
Time frame: Immediately after the procedure
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 6 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Definition Colonoscopy and Dye Spraying Chromocolonoscopy in people with Inflammatory Bowel Diseases and Colon Dysplasia, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
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 7 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy (time frame: Immediately after the procedure). 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 6 Mar 2026.