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

Madrid Health Service

Status: Unknown

Conditions: Chromoendoscopy

Treatments: Procedure: Chromoendoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04403997

NBICromo

Details and patient eligibility

About

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

Full 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.

Enrollment: 175 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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175 participants in 2 patient groups

Chromoendoscopy with methylene blue 0.1%

Active Comparator group

Description:

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.

Treatment:

Procedure: Chromoendoscopy

Virtual Chromoendoscopy with NBI with HQ190 endoscopes

Experimental group

Description:

Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode

Treatment:

Procedure: Chromoendoscopy