To evaluate the utility of the WATS system, as a potential substitute for the random sampling method that is currently recommended as an adjunct to targeted biopsy
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The detection rate of Barrett*s associated HGD and EAC using WATS and random 4
quadrants/2cm biopsies
Secondary outcome
The effect of order of sampling on the outcome.
Background summary
Esophageal adenocarcinoma (EAC) is a disease with a poor prognosis at advanced
stage. It is clear that identifying esophageal adenocarcinoma at an early and
treatable stage reduces morbidity and mortality. The incidence of Barrett*s
esophagus (BE) and associated EAC highly increased in the last years. Adequate
monitoring strategies and improved diagnostic procedures are therefore
essential.
The current systemic four-quadrant biopsy at 2-cm intervals of the dysplastic
and non-dysplastic BE segment leaves the majority of the BE epithelium
undiagnosed. Sampling BE cells with cytology brushes has been considered to
increase the sensitivity for dysplasia and EC. The limiting factors are the
superficial sampling and the difficulty of the analysis of the thick tissue
smear by a two-dimensional cytology microscope.
The WATS system (developed by CDx Diagnostics) consists of a trans-epithelial
cytology brush designed to sample cells from all three layers of the
epithelium and the diagnosis of the brush specimen by advanced computer image
analysis system at CDx Diagnostics. In this study, we will compare the
sensitivity of the WATS system with the random sampling method by
randomization of the order of sampling during an imaging endoscopy
Study objective
To evaluate the utility of the WATS system, as a potential substitute for the
random sampling method that is currently recommended as an adjunct to targeted
biopsy
Study design
This is an international, multi-center, prospective, randomized, tandem trial
Intervention
During the surveillance endoscopy eligible patients will be randomized to one
of the two arms of the study. Patients will undergo random 4 quadrant mucosal
biopsies every 2cm followed by WATS brushing of the BE segment (arm 1) or WATS
brushing followed by random 4 quadrant mucosal biopsies (arm 2).
Study burden and risks
The WATS biopsy will be done during an imaging endoscopy scheduled according
current guidelines. The amount of random biopsies during this endoscopy is as
in the current guidelines. The risks associated with upper endoscopy and WATS
are the same as those associated with upper endoscopy and routine forceps
biopsy. These risks and discomforts are associated with sedation and endoscopy
with forceps biopsy itself ( small amounts of bleeding, sore throat)
The minimal increase in time needed to obtain WATS samples will not add
significant risk to and will not require additional exposure to sedation.
Participation will not influence the treatment of the disease. The outcome of
the routine random biopsies only will be the guideline for further ablative
therapy or surveillance.
There is no direct benefit from taking part in this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
* Patients age: * 18 years
* Patients should have a history of Barrett*s associated esophageal neoplasia (either low or high-grade dysplasia on biopsy without visible lesions or well to moderately differentiated mucosal adenocarcinoma, without lymphovascular invasion after EMR) confirmed on histology
* Willingness to undergo both WATS and random forceps biopsies while undergoing conventional EGD with sedation
* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
* Only patients without visible lesions at the time that they undergo both random forceps biopsies and WATS testing of the esophagus will be included in this study
Exclusion criteria
* BE length < 2 cm circumferential extent or > 10 cm total extent
* Patients within six weeks of receiving targeted forceps biopsies and/or EMR
* Patients with visible mucosal lesion according to the Paris classification at the time of the WATS and random biopsy testing
* Patients with visible lesions that are either submucosal or covered with a clinically intact epithelium
* History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR), except for Nissen fundoplication
* Patients who have already undergone endoscopic ablative therapies
* Coagulopathy with INR >2.0, thrombocytopenia with platelet counts < 50,000
* The subject is pregnant or planning a pregnancy during the study period
* 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
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 | NCT03015389 |
| CCMO | NL62816.018.17 |