Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI

Detailed Description
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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.

Official Title
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Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease

Conditions
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Chromoendoscopy

Intervention / Treatment
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* Procedure: Chromoendoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chromoendoscopy with methylene blue 0.1%<br>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. | Procedure: Chromoendoscopy<br>* 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.<br>|
| Experimental: Virtual Chromoendoscopy with NBI with HQ190 endoscopes<br>Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode | Procedure: Chromoendoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesions detected | Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of dysplastic lesions | Number of patients with at least one dysplastic lesion | Baseline | 
| Non-dysplastic lesions | Assess the number of non-dysplastic lesions detected with both methods | Baseline | 
| Ratio of neoplastic lesions/total lesions | Compare the ratio of neoplastic lesions/total lesions between both groups | Baseline | 
| Total endoscopy time | The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal | 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 | Baseline | 
| Near Focus ability | Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions | Baseline | 
| Number of biopsies | Number of biopsies taken in the different groups | Baseline |