Back-to-back high-definition white light endoscopy versus single-pass high-definition white light endoscopy and chromoendoscopy in IBD surveillance (HELIOS study)

Back-to-back high-definition white light endoscopy versus single-pass high-definition white light endoscopy and chromoendoscopy in IBD surveillance (HELIOS study) - HELIOS study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49570

Enrollment

560

Registered

2020-02-20

Start date

2020-03-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel diseases

Interventions

A) HDWLE, B) back-to-back HDWLE or C) CE.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed informed consent - Patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis). - Previous assessable surveillance endoscopy > 1 year - Age > 18 years

Exclusion criteria

Exclusion criteria: - Active colitis > 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist. - Allergy or intolerance to methylene blue - Insufficient bowel cleansing (BBPS 50 % of the colon surgically removed

Design outcomes

Primary

Measure	Time frame
The detection rate of neoplasia (i.e. dysplasia and CRC) with the different endoscopic modalities	—

Secondary

Measure	Time frame
1. Number of all lesions for each technique. 2. Number of dysplastic lesions for each technique. 3. Characteristics of lesions: Kudo classification, Paris classification, location, size 4. Number of lesions detected at first and second examination (only in group back-to-back HDWLE) 5. Duration of total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique. 6. Number of biopsies taken in the different groups.	—

Measure

Time frame

1. Number of all lesions for each technique. 2. Number of dysplastic lesions for each technique. 3. Characteristics of lesions: Kudo classification, Paris classification, location, size 4. Number of lesions detected at first and second examination (only in group back-to-back HDWLE) 5. Duration of total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique. 6. Number of biopsies taken in the different groups.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)