Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment
Withdrawn before enrolling · Phase 2
Conditions studied: Esophageal Strictures, Esophageal Leak, Esophageal Perforation, Esophageal Fistula, Endostitch, Esophageal Stent
In brief
Esophageal stents are commonly used for benign esophageal pathology, especially strictures or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting factor to stent placement is the high migration rate of the stent. Investigators are trying to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign esophageal disease in comparison with standard, fully covered self-expanding metal stents (FCSEMS) placement without fixation.
Key facts
- Study ID
- NCT02751333
- Run by
- Johns Hopkins University
- People needed
- 0
- Starts
- 2016-03-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients age 18 years and older
- Patients with esophageal refractory benign strictures (peptic, anastomotic, caustic, radiation, and idiopathic) where a 14 mm luminal diameter cannot be achieved over 2 dilation sessions at 1-3-week intervals.
- Patients with esophageal leak, perforation, or fistula referred for endoscopic stenting
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if…
- Pediatric patients age under 18 years
- Pregnant or breastfeeding patients
- Patients with malignant esophageal lesions, primary or metastatic, requiring endoscopic stenting (all females of child bearing age will undergo urine pregnancy testing as per standard1 preprocedural testing)
- Benign strictures not having had two attempts at endoscopic dilation
- Uncorrectable coagulopathy defined by partial thromboplastin time (PTT) greater than 50 sec, or international normalized ratio (INR) greater than 1.5
- Uncorrectable thrombocytopenia with platelet count less than 50, 000
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.