A Trial of Esophageal and Gastric Stenting for Leak or Perforation

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.

Inclusion Criteria:

1. Patients must have radiographic or endoscopic proof of an esophageal leak or fistula.

2. Patients will be required to undergo imaging with CT scan, endoscopy, or fluoroscopy
to investigate the leak. Once the location of the leak is identified, then patients
must be taken for stenting and any adjunctive treatment within 12 hours of diagnosis
or within 12 hours of arrival to The Methodist Hospital.

3. Patients must sign informed consent indicating that they are aware of the
investigational nature of this study in keeping with the policies of the hospital.

Exclusion Criteria:

1. Patients who will not agree to return for routine follow-up and studies.

2. Patients who will not tolerate an endobronchial ultrasound or endoscopic procedure
(coagulopathy [INR>1.8, PTT>60, or platelet level <50], hemodynamically unstable
[MAP<50 or SBP<80], or other medical illness precluding safe endoscopy).

3. Patients who have a perforation too high to stent (such as the back of the pharynx,
where a stent is not able to be placed), the only unfavorable anatomic location is
this one listed above; we believe all other locations are amenable to stent
placement.

4. Resectable carcinoma, megaesophagus, severe stricture, or caustic ingestion.