Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment (NCT02751333) | Clinical Trial Compass
WithdrawnPhase 2
Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment
Stopped: The reason was the fact that the study was not clinically feasible.
United States0Started 2016-03
Plain-language summary
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.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy.