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

Chromoendoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403997
• Other study ID #: NBICromo
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 25, 2022

Study information

• Verified date: July 2021
• Source: Hospital Universitario La Paz
• Contact: Eduardo Martín Arranz, PhD
• Phone: +34912071350
• Email: emarranz[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: February 25, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chromoendoscopy
• Inflammatory Bowel Diseases

Intervention

Procedure:
• Chromoendoscopy
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesions detected	Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy	Baseline
Secondary	Detection rate of dysplastic lesions	Number of patients with at least one dysplastic lesion	Baseline
Secondary	Non-dysplastic lesions	Assess the number of non-dysplastic lesions detected with both methods	Baseline
Secondary	Ratio of neoplastic lesions/total lesions	Compare the ratio of neoplastic lesions/total lesions between both groups	Baseline
Secondary	Total endoscopy time	The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal	Baseline
Secondary	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
Secondary	Near Focus ability	Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions	Baseline
Secondary	Number of biopsies	Number of biopsies taken in the different groups	Baseline