Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | October 2010 |
| End Date: | May 2014 |
Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
The specific aim of this study is to determine the feasibility of marking target pathologic
locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial
cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of
biopsy.
locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial
cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of
biopsy.
Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance
following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts
General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and
cautery marking for targeted biopsy, the patients will undergo a standard of care clinical
Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study
requires the use of a balloon catheter which is a commonly used technique and is accepted in
clinical practice for dilation of esophageal and colonic strictures and for photodynamic
therapy.
Once in position, the OFDI tissue marking laser will be activated by the physician. The
physician will control the marking and make two marks of a duration of 2 seconds each. The 2
seconds time period will limit the tissue effects to only the superficial layers of the
esophageal mucosa.
It is expected that the total experimental time including insertion and inflation of the OFDI
balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add
approximately 15 minutes to the total length of the EGD.
following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts
General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and
cautery marking for targeted biopsy, the patients will undergo a standard of care clinical
Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study
requires the use of a balloon catheter which is a commonly used technique and is accepted in
clinical practice for dilation of esophageal and colonic strictures and for photodynamic
therapy.
Once in position, the OFDI tissue marking laser will be activated by the physician. The
physician will control the marking and make two marks of a duration of 2 seconds each. The 2
seconds time period will limit the tissue effects to only the superficial layers of the
esophageal mucosa.
It is expected that the total experimental time including insertion and inflation of the OFDI
balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add
approximately 15 minutes to the total length of the EGD.
Inclusion Criteria:
- Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed
Barrett's segment at least 1 cm in length
- Patients must be over the age of 18
- Patient must be able to give informed consent
- Women with child bearing potential must have a negative pregnancy test prior to
procedure
Exclusion Criteria:
- Patients on anti-platelet and anti-coagulation medications and NSAIDS at the time of
procedure
- Patients with a history of hemostasis disorders
- Patients that are pregnant
- Patients with esophageal strictures
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