The WATS-EURO2 Pilot study
- Conditions
- Barrett esophagus
- Registration Number
- NL-OMON24680
- Lead Sponsor
- one. Investigator initiated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 90
Patients age: = 18 years
- Willingness to undergo both WATS and random forceps biopsies while undergoing con-ventional EGD with sedation
- Ability to provide written, informed consent (approved by IRB and (biobank committee)) and understand the responsibilities of trial participation
- BE with a circumferential extent of =2cm, or a maximum extent of =4cm, and a total max-imum extent of =10cm (in case of prior ER: BE length after ER)
- Cohort 1: Patients referred for work-up of LGD, HGD or low-risk cancer (m1 to sm1, with-out lympho-vascular invasion and poor differentiation), either diagnosed in random biop-sies or in prior endoscopic resection specimen
- Cohort 2: Patients with known BE enrolled in endoscopic surveillance programs
Patients with visible lesions according to the Paris classification at the time of the WATS and random biopsy testing (prior endoscopic resection is allowed)
- Patients with high-risk cancer after endoscopic resection: either sm2/3 invasion, poor differentiation, lympho-vascular invasion, or R1 vertical resection margin
- Patients within six weeks of receiving targeted forceps biopsies and/or ER
- History of esophageal or gastric surgery other than Nissen fundoplication
- History of esophageal ablation therapy
- 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 instructions, or follow-up guidelines
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Test the feasibility of the infrastructure, data collection, and the study database (in-cluding sending automatic e-mails, advising on surveillance intervals, reminding phy-sicians to schedule FU endsocopies, etc)<br>- To study the rate of HGD/EAC (biopsy diagnosed) in BE patients at high risk of progression (i.e. after endoscopic removal of visible lesions containing HGD/EAC and/or a diagnosis of LGD) and in BE patients undergoing standard endoscopic surveillance.<br>- To study the concordance/discordance between random biopsies and WATS brushing collected at the baseline endoscopy and at follow-up endoscopies for the diagnosis HGD/EAC.<br>- To study the rate of progression to HGD/EAC in endoscopic biopsies (targeted or random) or endoscopic resection specimens during follow-up, after a baseline WATS-positive-biopsy negative diagnosis for HGD/EAC.
- Secondary Outcome Measures
Name Time Method To study the concordance/discordance between random biopsies and WATS brushing collected at the baseline endoscopy and at follow-up endoscopies for the diagnosis intestinal metaplasia.<br>- To study the rate of diagnosing intestinal metaplasia in endoscopic biopsies during follow-up, after a baseline WATS-positive-biopsy-negative diagnosis for intestinal metaplasia.<br>To evaluate the rate of progression to HGD/EAC in endoscopic biopsies (targeted or random) or endoscopic resection specimens during follow-up, after a baseline diagnosis WATS3D brush crypt dysplasia diagnosis.<br>- To assess whether a positive finding of HGD/EAC using the WATS system is reproducible on subsequent endoscopies.