TECR & ECM Placement for Esophageal High Grade Dysplasia

Stopped early · Not applicable

Conditions studied: Barrett Esophagus, Esophagus, High Grade Dysplasia

In brief

This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has been introduced as a less invasive, externally incision-less approach to treat patients with esophageal high grade dysplasia; a pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa (esophagus lining) will be removed using an endoscope that will be inserted through the mouth. The ECM will be placed over the area that is being removed with a temporary, expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the ECM in place as the body begins the healing process. This stent will be removed 14 days (±4 days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow x-ray tests, and questionnaires will take place for 12 months following the procedure. The result of this study may help doctors determine if this procedure would be a more effective treatment option for HGD in the future.

Key facts

Study ID

NCT02396745

Run by

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

People needed

1

Starts

2016-01-25

Expected to finish

2018-03-22

Last updated by the study team

2019-03-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.

Where it is running

• West Penn Allegheny Health System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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