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

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

Study Overview

• Status: Recruiting
• Conditions: Chromoendoscopy
• Intervention / Treatment: Procedure: Chromoendoscopy

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 Type: Interventional
• Enrollment (Anticipated): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Chromoendoscopy with methylene blue 0.1%; 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; 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.
EXPERIMENTAL: Virtual Chromoendoscopy with NBI with HQ190 endoscopes; Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Investigators: Principal Investigator: Eduardo Martín Arranz, PhD, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): February 25, 2022

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: NBICromo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No