Barrett esophagus
Conditions
Interventions
None listed
Sponsors
None. Investigator initiated
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) - 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. - 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. - 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
| Measure | Time frame |
|---|---|
| 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. - 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. 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. - To assess whether a positive finding of HGD/EAC using the WATS system is reproducible on subsequent endoscopies. | — |
Contacts
Public ContactAmir Khoshiwal
Amsterdam UMC
Outcome results
None listed