Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.
This study is written to evaluate our experience treating esophageal fistulas with occlusive self-expanding covered metal stents. The long-term outcomes of patients treated with this new type of stent are as yet unknown. The differences between these stents is also unknown, as well as the ease of removal, efficacy, and/or placement. The intent of this study is not to determine which stent is better, but to merely evaluate the use of both. With this in mind, there will be no randomization of stent use, nor will there be restrictions on which stent may be used in which setting. This will be left to the judgment of the clinical placing the stent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Stent used to maintain luminal patency in esophageal strictures and occlude esophageal fistulas to reduce gastric leaks, perforations and/or fistulas.
The Methodist Hospital
Houston, Texas, United States
Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Time frame: 15 - 30 days
Efficacy of esophageal stenting by the success of leakage stops and fistula healing.
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Time frame: 15 - 30 days
A 30 day duration of stent placement and the relation to the healing esophagus
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. Evaluation of the healing process of the esophagus within first 30 days with the capability of its removal procedure. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Time frame: 30 days
An institutional protocol for stent management
Results will be considered for assessing and instituting an institutional protocol to become the standard of care for future patient situations.
Time frame: 1 year
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