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

Hospital Universitario La Paz175 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

175

Conditions

Chromoendoscopy

Interventions

ChromoendoscopyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

Lesions detected

Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy

Time frame: Baseline

Secondary Outcomes

Detection rate of dysplastic lesions

Number of patients with at least one dysplastic lesion

Time frame: Baseline

Non-dysplastic lesions

Assess the number of non-dysplastic lesions detected with both methods

Time frame: Baseline

Ratio of neoplastic lesions/total lesions

Compare the ratio of neoplastic lesions/total lesions between both groups

Time frame: Baseline

Total endoscopy time

The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal

Time frame: 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

Time frame: Baseline

Near Focus ability

Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions

Time frame: Baseline

Number of biopsies

Number of biopsies taken in the different groups

Time frame: Baseline

Central Contacts

Eduardo Martín Arranz, PhD

CONTACT

+34912071350 emarranz@salud.madrid.org

Data from ClinicalTrials.gov

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