Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

Esophageal Cancer Clinical Trial

Official title:

Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00903136
• Other study ID #: CDR0000641937
• Secondary ID: VAMC-WA-33141
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 15, 2009
• Last updated: January 9, 2014
• Start date: May 2009

Study information

• Verified date: February 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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 The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is reached.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• questionnaire administration

Procedure:
• comparison of screening methods

• diagnostic endoscopic procedure

• esophagogastroduodenoscopy

• tethered capsule endoscopy

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I)			No
Primary	Time required to image the squamo-columnar junction (Phase I)			No
Primary	Number of repeated swallows to achieve esophageal imaging (Phase I)			No
Primary	Amount of simethicone needed to reduce bubbles (Phase I)			No
Primary	Need for effervescent granules or other approaches to distend the esophagus (Phase I)			No
Primary	Time required for the entire TCE procedure (Phase I)			No
Primary	Quality of images (clarity, color, field of view, and resolution) obtained in the entire TCE procedure (Phase I)			No
Primary	Overall comfort during ingestion, pullback, and withdrawal of the TCE (Phase I)			No
Primary	Sensitivity, specificity, and accuracy of the TCE for identifying suspected Barrett esophagus (Phase II)			No
Primary	Agreement between the findings on the live TCE exam with the recorded TCE exam (Phase II)			No
Primary	Time to perform the TCE exam (Phase II)			No
Primary	Test characteristics of the first half vs the last half of the TCE exams performed by each of the 2 endoscopists (Phase II)			No
Primary	Comparison of participants' satisfaction with the TCE vs esophagogastroduodenoscopy (Phase II)			No
Secondary	Ability of the TCE to identify the presence or absence of other esophageal lesions (e.g., inflammation, diverticula, or varices) (Phase II)			No
Secondary	Results of the histologic analysis of any biopsy specimens (Phase II)			No