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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis

NCT01882205

Ulcerative Colitis

RECRUITING NA

Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

NCT04192929

Colorectal Neoplasms

WITHDRAWN NA

NBI With Magnification for Dysplasia Detection in Ulcerative Colitis

NCT00292175

Ulcerative Colitis

UNKNOWN NA

Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance

NCT04291976

Inflammatory Bowel Diseases Colorectal Neoplasms

COMPLETED NA

High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps

NCT03243669

Colonic Adenoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chromoendoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Chromoendoscopy

Intervention Type PROCEDURE

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.

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

Group Type EXPERIMENTAL

Chromoendoscopy

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No