Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

The MGH will be the first site in the multi-center study to begin enrolling. At the MGH

100 participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.

Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around

the time of inclusion into the study and one at the end of the study, and 4 TCE imaging

sessions (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is

determined by the treating physician that additional EGDs are needed, for extended

follow-up or treatment, capsule imaging will be performed whenever possible.

Participants will have received written information prior to the day of the capsule

procedure and participants will have another chance to discuss the procedure with the

study coordinator and clinical study staff during the consent process prior to the

capsule procedure. Participation in this study is completely voluntary, and the

participant can stop the procedure at any time.

For each of the imaged participants, inclusion criteria and clinical characteristics such

as age, sex, body mass index (BMI), current medication regimen, smoking history and GI

related history will be recorded in the clinical form.

Participants will be seated and asked to sip water to facilitate swallowing the capsule.

The device will be operated by experienced study staff trained in the procedure such as a

registered nurse or one of the endoscopist co-investigators in this study. Emergency

phone and/or pager contact of the collaborating GI clinician(s) will be provided. They

will also be accessible during the procedure if any problems are encountered that require

their expertise.

Imaging will be performed in the same manner as in our other current IRB approved

tethered capsule endomicroscopy studies. The capsule position will be controlled manually

via the tether outside of the participant's mouth by the catheter operator. Recorded

real-time cross-sectional images displayed on the monitor and distance marks on the

tether will be used for confirmation of capsule position in the esophagus. Images will be

viewed in real time to determine when the capsule has reached the stomach. The resistance

of the tether can also give information of the cardia position. Once in the stomach, the

capsule will be gradually pulled back up through the esophagus to the mouth, also while

imaging. The capsule may be repositioned for imaging up to 4 times up and 4 times down

the esophagus. The participant may be asked to swallow a different size capsule (ranging

from 5-12.8 mm in diameter and 20-30 cm in length) to obtain the best distal esophageal

images. It is expected that the maximum experimental time including swallowing the

capsule, the imaging procedure, and removal of the capsule will take approximately 10

minutes in total.