A Trial of Esophageal and Gastric Stenting for Leak or Perforation
Completed · Phase 2
Conditions studied: Esophageal or Gastric Perforations, Esophageal or Gastric Leaks
In brief
Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.
Key facts
- Study ID
- NCT01107249
- Run by
- The Methodist Hospital Research Institute
- People needed
- 10
- Starts
- 2010-05-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2016-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have radiographic or endoscopic proof of an esophageal leak or fistula.
- 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.
- 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.
You may not qualify if…
- Patients who will not agree to return for routine follow-up and studies.
- 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).
- 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.
- Resectable carcinoma, megaesophagus, severe stricture, or caustic ingestion.
Where it is running
- The Methodist Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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