Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope
18 Years
80 Years
Both
Esophageal Cancer, Precancerous Condition
Trial Information
Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope
OBJECTIVES:
- To determine the clinical feasibility of obtaining endoscopic esophageal images using a
tethered capsule endoscope (TCE). (Phase I)
- To determine the optimal weight and possibly shape for rapid patient ingestion and
extraction of the TCE. (Phase I)
- To determine the optimal tether design (e.g., rigidity, distance markings, and other
material properties). (Phase I)
- To determine the optimal protocol for patient ingestion and extraction of the TCE.
(Phase I)
- To compare the TCE to standard sedated esophagogastroduodenoscopy for identifying
suspected Barrett esophagus. (Phase II)
OUTLINE:
- Phase I: Participants swallow the tethered capsule endoscope (TCE) so that the distal
end of the TCE enters the stomach. The TCE is then slowly withdrawn by the physician in
order to visualize the gastroesophageal junction and the esophagus in a retrograde
fashion until the upper esophageal sphincter is reached. The image acquisition process
is repeated and the participant may be asked to swallow the TCE in up to 7 different
positions with 2 swallows per position (no more than 20 swallows total).
- Phase II: Participants undergo TCE as in phase I, followed by standard sedated
esophagogastroduodenoscopy (EGD) by a second physician.
Images obtained via TCE and EGD are reviewed by a third physician blinded to the results of
each exam.
In both phases, participants and physicians complete a questionnaire after the TCE procedure
to determine the ease of the procedure. Participants are also asked for specific suggestions
to improve the TCE experience. Participants enrolled in phase II also complete a
questionnaire 1 week after EGD to compare the TCE procedure with the EGD.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Meets one of the following criteria:
- Healthy participant (phase I)
- Scheduled to undergo esophagogastroduodenoscopy at the VA Puget Sound Health
Care System for the evaluation of reflux symptoms (including screening for
Barrett esophagus [BE]) or for follow-up of known BE (phase II)
- No current diagnosis of cancer
PATIENT CHARACTERISTICS:
- Not pregnant
- Able to fast for ≥ 6 hours prior to scheduled appointment
- No symptoms of dysphagia
- No history of a swallowing disorder (e.g., scleroderma, achalasia, esophageal
stricture, or esophageal diverticulum)
- No history of a known or suspected gastrointestinal (GI) obstruction
- No other major medical illnesses (e.g., unstable cardiovascular disease, end-stage
liver or kidney disease, or suspected active GI bleeding)
- No major physical disability that would prevent the participant from transferring
from a chair to a bed and sitting up
- Not planning to undergo an MRI within 2 weeks after the study procedure
PRIOR CONCURRENT THERAPY:
- No prior surgery on the oropharynx, neck, esophagus, or stomach
- No concurrent anticoagulant medications or clopidogrel
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I)
Safety Issue:
No
Principal Investigator
Jason A. Dominitz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Veterans Affairs
Authority:
Unspecified
Study ID:
CDR0000641937
NCT ID:
NCT00903136
Start Date:
May 2009
Completion Date:
Related Keywords:
- Esophageal Cancer
- Precancerous Condition
- Barrett esophagus
- esophageal cancer
- adenocarcinoma of the esophagus
- Barrett Esophagus
- Esophageal Diseases
- Esophageal Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
