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

Not Applicable

• Conditions: Chromoendoscopy
• Interventions: Procedure: Chromoendoscopy

• Registration Number: NCT04403997
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

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 Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23
• Primary Completion: 2021-12-30
• Study Completion: 2022-02-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Chromoendoscopy with NBI with HQ190 endoscopes	Chromoendoscopy	Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode
Chromoendoscopy with methylene blue 0.1%	Chromoendoscopy	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.

Primary Outcome Measures

Name	Time	Method
Lesions detected	Baseline	Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain