Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus - Full Text View

Sponsor:	Department of Veterans Affairs
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00903136

Purpose

RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of the esophagus, stomach, and duodenum in screening for Barrett esophagus.

PURPOSE: This phase I/II trial is studying how well a tethered capsule endoscope works in screening participants for Barrett esophagus.

Condition	Intervention	Phase
Esophageal Cancer Precancerous Condition	Other: questionnaire administration Procedure: comparison of screening methods Procedure: diagnostic endoscopic procedure Procedure: esophagogastroduodenoscopy Procedure: tethered capsule endoscopy	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Screening
Official Title:	Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I) [ Designated as safety issue: No ]
Time required to image the squamo-columnar junction (Phase I) [ Designated as safety issue: No ]
Number of repeated swallows to achieve esophageal imaging (Phase I) [ Designated as safety issue: No ]
Amount of simethicone needed to reduce bubbles (Phase I) [ Designated as safety issue: No ]
Need for effervescent granules or other approaches to distend the esophagus (Phase I) [ Designated as safety issue: No ]
Time required for the entire TCE procedure (Phase I) [ Designated as safety issue: No ]
Quality of images (clarity, color, field of view, and resolution) obtained in the entire TCE procedure (Phase I) [ Designated as safety issue: No ]
Overall comfort during ingestion, pullback, and withdrawal of the TCE (Phase I) [ Designated as safety issue: No ]
Sensitivity, specificity, and accuracy of the TCE for identifying suspected Barrett esophagus (Phase II) [ Designated as safety issue: No ]
Agreement between the findings on the live TCE exam with the recorded TCE exam (Phase II) [ Designated as safety issue: No ]
Time to perform the TCE exam (Phase II) [ Designated as safety issue: No ]
Test characteristics of the first half vs the last half of the TCE exams performed by each of the 2 endoscopists (Phase II) [ Designated as safety issue: No ]
Comparison of participants' satisfaction with the TCE vs esophagogastroduodenoscopy (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ability of the TCE to identify the presence or absence of other esophageal lesions (e.g., inflammation, diverticula, or varices) (Phase II) [ Designated as safety issue: No ]
Results of the histologic analysis of any biopsy specimens (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2009
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903136

Locations

United States, Washington
Veterans Affairs Medical Center - Seattle	Recruiting
Seattle, Washington, United States, 98108
Contact: Jason A. Dominitz, MD 206-764-2285

Sponsors and Collaborators

Department of Veterans Affairs

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jason A. Dominitz, MD

Department of Veterans Affairs

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jason A. Dominitz, Veterans Affairs Medical Center - Seattle
ClinicalTrials.gov Identifier:	NCT00903136 History of Changes
Other Study ID Numbers:	CDR0000641937, VAMC-WA-33141
Study First Received:	May 15, 2009
Last Updated:	February 2, 2010
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

Barrett esophagus
esophageal cancer
adenocarcinoma of the esophagus

Additional relevant MeSH terms:

Barrett Esophagus
Esophageal Diseases
Esophageal Neoplasms
Precancerous Conditions
Digestive System Abnormalities
Digestive System Diseases

Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 23, 2012