We aim to compare EMR and ESD for removal of visible lesions in Barrett*s esophagus.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the proportion of patients with no evidence of residual or
local recurrent neoplasia during 12 months follow-up after baseline.
Secondary outcome
- Incidence of perforation
- Incidence of post-procedural bleeding
- Incidence of esophageal stenosis
- Procedure times
- Proportion of patients with endoscopically radical resection
- Cost-effectiveness
- Total number of ER endoscopies per patient
- Proportion of patients with (progression to) high-risk EAC
- Proportion of patients in whom additional non-endoscopic therapy is required
Background summary
The optimal technique for removal of visible dysplastic lesions in Barrett*s
esophagus remains controversial. Endoscopic mucosal resection (EMR) is safe,
effective, easy to apply, and has been the most widely used technique since
2008. Endoscopic submucosal dissection (ESD) is a more controlled dissection
method with potential improved efficacy, but at the cost of higher technical
complexity.
Study objective
We aim to compare EMR and ESD for removal of visible lesions in Barrett*s
esophagus.
Study design
Prospective, randomized study to evaluate two regluar treatment techniques
Intervention
Not applicable
Study burden and risks
Both techniques are assumed safe and effective for removal of visible lesions
in Barrett*s esophagus in current clinical guidelines. EMR is the most widely
used technique nowadays, and ESD may be more effective, but head-to-head
comparisons are lacking. There is sincere doubt about which of the techniques
is better, if any. We therefore assume there is no risk for suboptimal
treatment for participants in either arm of the study. Patients undergo 1 year
follow-up after resection, while guidelines suggest that direct ablation
therapy could be considered. However, the frequent FU visits and careful
assessment during each FU visit, as dictated in the protocol, prevent the risk
for progression of disease during FU. Patients are also asked to complete a
digital diary during the first days after baseline. Apart from removal of the
lesion with an efficient technique, in line with standard care, there is no
additional benefit for participants of the study.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- Patients age: >= 18 years
- Willingness to undergo both EMR or ESD
- Ability to provide written, informed consent (approved by IRB) and understand
the responsibilities of trial participation
- BE with a single visible lesion with absence of signs of submucosal invasion
on endoscopy, after evaluation by the adjudication committee.
- Minimum diameter of the lesion >=15mm (in either direction)
Exclusion criteria
- Patients with visible lesions with suspicion of submucosal invasion bases on
assessment of the adjudication committee
- Patients with HGD in at least one random biopsy, before inclusion (i.e.
during endoscopy in the referring center < 3 months before imaging, or during
imaging endoscopy)
- History of esophageal surgery other than fundoplication
- History of esophageal ablation therapy or endoscopic resection
- Multiple visible lesions in the BE segment at baseline
- Uncontrolled coagulopathy with INR >2.0, thrombocytopenia with platelet
counts < 50,000
- Subject has a known history of unresolved drug or alcohol dependency that
would limit ability to comprehend or follow instructions related to informed
consent, post-treatment in-structions, or follow-up guidelines
- Life expectancy <2 years
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05276791 |
| CCMO | NL80859.100.22 |