ChromoendoscopyNCT04403997
Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
A study testing Chromoendoscopy in people with Chromoendoscopy, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chromoendoscopy
- What is being tested?
- Chromoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 25 Feb 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy
Who cannot join
- Patients who are not trained to understand the nature of the study, the procedures to be followed or are not able to sign an informed consent
- Known allergy or intolerance to methylene blue
- Pregnant or lactating women
- Personal history of colorectal cancer
- Ulcerative colitis active more than 20 cm from the anal verge
- Patients with known G6PD deficiency
- Severe kidney failure
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Eduardo Martín Arranz, PhD, +34912071350, emarranz@salud.madrid.org
About this study
Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI
Read the detailed description
Single-blind (patient) randomized study to compare detection of neoplastic lesions between chromoendoscopy and NBI.
Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to usual clinical criteria will be included. The endoscopic procedure is similar to the one usually performed. All patients will undergo colonoscopy according to the usual procedure, with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the faecal remains will be thoroughly washed.
Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1% methylene blue or New generation NBI with Near focus.
Biopsies will be taken of all those lesions detected, instead of random biopsies.
- Conditions
- Chromoendoscopy
- Being tested
- Chromoendoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromoendoscopyProcedure or surgery
Chromoendoscopy is an endoscopic technique used in the follow-up of inflammatory bowel disease of long evolution. Chromoendoscopy, through the application of specific dyes used directly on the intestinal mucosa, promotes the visualization of mucosal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Chromoendoscopy with methylene blue 0.1% | Active comparator | Once the cecum is reached, a spray catheter is introduced through the working channel and the dye, a 0.1% methylene blue solution, is applied. Receives: Procedure: Chromoendoscopy |
| Virtual Chromoendoscopy with NBI with HQ190 endoscopes | Experimental | Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode Receives: Procedure: Chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions detected
Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy
Measured: Baseline
Secondary outcomes (7)
Detection rate of dysplastic lesions
Number of patients with at least one dysplastic lesion
Measured: Baseline
Non-dysplastic lesions
Assess the number of non-dysplastic lesions detected with both methods
Measured: Baseline
Ratio of neoplastic lesions/total lesions
Compare the ratio of neoplastic lesions/total lesions between both groups
Measured: Baseline
Total endoscopy time
The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal
Measured: Baseline
Removal time
Withdrawal time is counted from the time the cecum is reached to the completion of the test, including time spent on staining, biopsy or polypectomy
Measured: Baseline
Near Focus ability
Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions
Measured: Baseline
Number of biopsies
Number of biopsies taken in the different groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Oct 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion25 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChromoendoscopyStudies 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
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
- Investigators
- Eduardo Martín Arranz, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403997
- Sponsor's protocol ID
- NBICromo
- Status last verified
- Jul 2021
- First submitted
- 21 May 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04403997
- Acronym / sponsor ID
- NBICromo
- Conditions
- Chromoendoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 25 Feb 2022 (estimated)
- First posted
- 27 May 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.
Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI
Detailed description
Single-blind (patient) randomized study to compare detection of neoplastic lesions between chromoendoscopy and NBI.
Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to usual clinical criteria will be included. The endoscopic procedure is similar to the one usually performed. All patients will undergo colonoscopy according to the usual procedure, with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the faecal remains will be thoroughly washed.
Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1% methylene blue or New generation NBI with Near focus.
Biopsies will be taken of all those lesions detected, instead of random biopsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromoendoscopy with methylene blue 0.1% | Active comparator | Procedure: ChromoendoscopyOnce the cecum is reached, a spray catheter is introduced through the working channel and the dye, a 0.1% methylene blue solution, is applied. |
| Virtual Chromoendoscopy with NBI with HQ190 endoscopes | Experimental | Procedure: ChromoendoscopyIntubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy
Key exclusion criteria (7 listed)
- Patients who are not trained to understand the nature of the study, the procedures to be followed or are not able to sign an informed consent
- Known allergy or intolerance to methylene blue
- Pregnant or lactating women
- Personal history of colorectal cancer
- Ulcerative colitis active more than 20 cm from the anal verge
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 |
|---|---|---|
| ChromoendoscopyChromoendoscopy is an endoscopic technique used in the follow-up of inflammatory bowel disease of long evolution. Chromoendoscopy, through the application of specific dyes used directly on the intestinal mucosa, promotes the visualization of mucosal lesions. | Procedure or surgery | Chromoendoscopy with methylene blue 0.1%, Virtual Chromoendoscopy with NBI with HQ190 endoscopes |
Primary outcome
Lesions detected
Time frame: Baseline
Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy
7 secondary outcomes
Detection rate of dysplastic lesions
Time frame: Baseline
Non-dysplastic lesions
Time frame: Baseline
Ratio of neoplastic lesions/total lesions
Time frame: Baseline
Total endoscopy time
Time frame: Baseline
Removal time
Time frame: Baseline
Near Focus ability
Time frame: Baseline
Number of biopsies
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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IBD
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.
Eduardo Martín Arranz, PhD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromoendoscopy in people with Chromoendoscopy, run by Hospital Universitario La Paz at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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 Spain. 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 Eduardo Martín Arranz, PhD (+34912071350, emarranz@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesions detected (time frame: Baseline). 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 23 Jul 2021.