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This project is being done to compare two current treatment clinical options for management of RBES: 1) Frequent dilations followed by temporary esophageal stent placement if dilations fail, or 2) Early stent placement followed by dilations
This study aims to explore the safety and effectiveness of two clinical treatment approaches used to manage RBES patients-Temporary early-stent placement versus late stenting.
For normal swallowing, the esophagus (food pipe) lumen should be equal to or more than 14 mm in diameter. In those with stricture (narrowing) of the esophagus from benign causes, initial endoscopic management is serial sessions of dilation (stretching) to achieve and maintain a diameter of ≥14mm. Many strictures may not respond to this approach (refractory). Esophageal stents (18 mm - 23 mm diameter) temporarily placed for 2 weeks using an endoscope are also used dilate and remold the stricture. While in place, patients can swallow. This can save the patient from undergoing repeated dilations. Stents can be placed either late in the process of management after several traditional dilations have failed or early in the management to rapidly achieve a diameter of ≥14 mm and then continuing traditional dilations.
Although either of above two approaches can be used for the clinical management of RBES, in this study the investigators plan to randomly assign patients to start with one of the two approaches and compare outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Late-stent approach | Active Comparator | Repeated dilations at weekly intervals, and based on the response, the intervals between dilations are adjusted, and if still no response, place a removable FCSEMS (18 mm diameter). The stent will be removed in 2 weeks followed again by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more. |
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| Early-stent approach | Active Comparator | Removable FCSEMS (18 mm diameter) placed on index endoscopy and removed after 2 weeks followed by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully covered self-expandable metal esophageal stent | Device | Esophageal stent placement for patients with benign esophageal strictures not responding to endoscopic dilations. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve esophageal luminal diameter to ≥14 mm | The duration required to achieve and maintain an esophageal diameter of ≥14 mm using the two techniques. | From enrollment to follow up, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | From enrollment to follow up, up to 2 years | |
| Recurrence rate of esophageal stricture | From enrollment to follow up, up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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