Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Neoplasms
- Inflammatory Bowel Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE...
The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required. To demonstrate a superiority of back-to-back HDWLE compared to a regular HDWLE, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. Therefore, the investigators will include 226 patients in group back-to-back HDWLE, 226 in group CE, and 113 patients in group regular HDWLE. This amounts to a total of 560 patients. To account for any screen-failures The investigators will include at most 5% (of 560) additional patients until 80% power is reached.
Tracking Information
- NCT #
- NCT04291976
- Collaborators
- UMC Utrecht
- Leiden University Medical Center
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Principal Investigator: Frank Hoentjen, MD PhD Radboud University Principal Investigator: Bas Oldenburg, MD PhD UMC Utrecht
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