to determine the number of sufficient quality samples obtained through the use of the Cytosponge, which could potentially serve as a substitute for endoscopic sampling.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of samples collected with the Cytosponge that contain columnar cells
and are processed to clot preparations that are at least 5mm in size.
Secondary outcome
The number of successful Cytosponge study procedures.
The concordance between the pathology review of endoscopic samples and
samples collected with the Cytosponge
The concordance between 2 samples of the same subject taken with the Cytosponge
Background summary
In the western world, there is an alarming increase in incidence of esophageal
cancer and Barrett's esophagus (BE). As the incidence is increasing and better
screening tools become available, a large group of patients with BE will be
enrolled in BE surveillance programs.
Esophageal adenocarcinoma (EAC) has a poor prognosis when diagnosed at an
advanced stage. Therefore, an adequate surveillance strategy is necessary as it
enables early detection and identification of EAC, allowing endoscopic
treatment with lower mortality and morbidity.
However, endoscopic surveillance of BE patients with a low risk of progression
is expensive, burdensome for the patient and time consuming. Still these
regular surveillance endoscopies are required because there is no proper
substitute. In order to unburden these low risk patients and ensure adequate
utilization of health care resources, there is a need for a reliable
alternative surveillance strategy.
The Cytosponge is a Trans Oral Sampling (TOS) device that can be easily
administered. The TOS device was previously mainly investigated in the setting
of screening for the presence of BE, but the potential for surveillance of
known BE patients remains unclear. With good quality sampling using the
Cytosponge, trans oral sampling could be a better alternative to endoscopic
surveillance of Barrett*s Esophagus.
Study objective
to determine the number of sufficient quality samples obtained through the use
of the Cytosponge, which could potentially serve as a substitute for endoscopic
sampling.
Study design
This is a single centre, prospective pilot study on the feasibility of trans
oral sampling for surveillance of Barretts esophagus patients.
Study burden and risks
burden and risk are minimal; however, only the additional hospital visits for
patients in cohort 2 can be considered burdensome
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients age: >= 18 years
- BE with a maximal extent of >=4cm
- Cohort 1: Patients referred for endoscopic treatment of HGD or EAC
- Cohort 2: Patients with known BE without a diagnosis of HGD or EAC in the
previous 18 months, undergoing endoscopic surveillance
- Ability to give written, informed consent and understand the responsibilities
of participation
Exclusion criteria
• Patients within eight weeks after endoscopy with biopsies and/or ER
• History of esophageal or gastric surgery other than Nissen fundoplication
• History of esophageal ablation or dilation therapy
• Presence of esophageal varices and/or suspected portal hypertension
• pregnancy
• present Dysphagia/ swallowing disorders at the time of screening and
participation
• Patients with known or suspected anatomical abnormalities of the esophagus or
stomach
• Patients taking anti-thrombotic drugs that cannot be temporarily discontinued
• 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
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 |
|---|---|
| CCMO | NL84099.018.23 |