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

Primary Purpose

Chromoendoscopy

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chromoendoscopy
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chromoendoscopy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario La PazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chromoendoscopy with methylene blue 0.1%

Virtual Chromoendoscopy with NBI with HQ190 endoscopes

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Detection rate of dysplastic lesions
Number of patients with at least one dysplastic lesion
Non-dysplastic lesions
Assess the number of non-dysplastic lesions detected with both methods
Ratio of neoplastic lesions/total lesions
Compare the ratio of neoplastic lesions/total lesions between both groups
Total endoscopy time
The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal
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
Near Focus ability
Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions
Number of biopsies
Number of biopsies taken in the different groups

Full Information

First Posted
May 21, 2020
Last Updated
July 22, 2021
Sponsor
Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT04403997
Brief Title
Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
Official Title
Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
February 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chromoendoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chromoendoscopy with methylene blue 0.1%
Arm Type
Active Comparator
Arm 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.
Arm Title
Virtual Chromoendoscopy with NBI with HQ190 endoscopes
Arm Type
Experimental
Arm Description
Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode
Intervention Type
Procedure
Intervention Name(s)
Chromoendoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lesions detected
Description
Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Detection rate of dysplastic lesions
Description
Number of patients with at least one dysplastic lesion
Time Frame
Baseline
Title
Non-dysplastic lesions
Description
Assess the number of non-dysplastic lesions detected with both methods
Time Frame
Baseline
Title
Ratio of neoplastic lesions/total lesions
Description
Compare the ratio of neoplastic lesions/total lesions between both groups
Time Frame
Baseline
Title
Total endoscopy time
Description
The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal
Time Frame
Baseline
Title
Removal time
Description
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
Title
Near Focus ability
Description
Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions
Time Frame
Baseline
Title
Number of biopsies
Description
Number of biopsies taken in the different groups
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Martín Arranz, PhD
Phone
+34912071350
Email
emarranz@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Martín Arranz, PhD
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Martín Arranz, PhD
Phone
+34912071350
Email
emarranz@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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