TECR & ECM Placement for Esophageal High Grade Dysplasia
Barrett Esophagus, Esophagus, High Grade Dysplasia
About this trial
This is an interventional treatment trial for Barrett Esophagus
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age and no more than 80 years of age.
Have an established diagnosis of HGD
a. Specific diagnosis and grading will be determined by pathology review of biopsy tissue collected during baseline EGD as part of a patient's standard of care.
- Have no evidence of lymphovascular invasion.
- Have no lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
- Diameter of affected tissue must warrant circumferential excision a. Subjects must have biopsy confirmed HGD in three of four esophageal quadrants at two levels spaced two centimeters apart (minimum of 6/8 biopsies indicating HGD). If two biopsies are normal (contain no HGD) they must be located on separate levels in two different quadrants.
5. Must be an appropriate or reasonable surgical candidate. 6. Have demonstrated an understanding and signed an approved informed consent form for participation in this study.
Exclusion Criteria:
Have lesions into or deeper than mucosal layer (superficial (T1a) Esophageal adenocarcinoma).
a. Those requiring endoscopic submucosal dissection (ESD) are not eligible for this study
- Have presence of lymphovascular invasion.
- Require resection length longer than 10 cm.
- Have any lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
- Have history of any kind of previous esophageal surgery (i.e. anti-reflux surgery).
- Are pregnant or planning to become pregnant.
- Have coagulation disorders.
- Have a known hypersensitivity to porcine-based materials.
- Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
- Has a clinically significant psychological illness that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
Are unable or unwilling to provide informed consent and/or fulfill the protocol follow-up requirements.
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Sites / Locations
- West Penn Allegheny Health System
Arms of the Study
Arm 1
Experimental
TECR & ECM
Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM)