A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures
Esophageal anastomotic stricture post esophagectomy (esophagogastric
- Esophagectomy performed at the same institution where patient enrollment and
follow-up is planned.
- Two dilations to at least 16 mm in diameter since esophagectomy.
- 1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6
months of 1st dilation to 16mm.
- Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow
liquids only) or 4 (unable to swallow liquids) at baseline.
- Unable to pass a standard endoscope (approx. 9.8 mm diameter).
- Age 18 years or older.
- Willing and able to comply with the study procedures and provide
Exclusion Criteria:Stricture within 2 cm of the upper esophageal sphincter.
- Dysphagia related to motility disorder.
- Non-anastomotic esophageal strictures.
- Esophagocolonic strictures.
- Planned adjuvant radiation therapy post esophagectomy.
- Prior esophageal stent placements post esophagectomy.
- Active erosive esophagitis.
- Sensitivity to any components of the stent or delivery system.
- Concurrent medical condition that would affect the investigator's ability to evaluate
the patient's condition or could compromise patient safety. Participation in a
clinical trial evaluating an investigational device within 3 months prior to
enrollment in this study.
- Stricture length > 5 cm.