Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment
Esophageal Strictures, Esophageal Leak, Esophageal Perforation
About this trial
This is an interventional treatment trial for Esophageal Strictures focused on measuring Esophageal stricture, Esophageal leak, Esophageal perforation, Esophageal fistula, Endostitch, Esophageal stent
Eligibility Criteria
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
- Uncorrectable thrombocytopenia with platelet count less than 50, 000
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
FCSEMS with Endostitching (ES)
FCSEMS with No Suturing (NS)
General anesthesia or conscious sedation will be started and an upper endoscope will be inserted into the participants mouth and advanced into the stomach. Endoscopic stenting with a fully covered self-expanding metal stents (FCSEMS) will then be performed. Once the stent is in place, the endoscope will be withdrawn from the participant to set-up the endostitch device unto the endoscope. Bites are taken separately with the first on the esophageal mucosa followed by a second on the stent itself and finishing with a last bite on esophageal mucosa. A cinch is then used to secure the deployed suture. An attempt at placing 2 sutures will be performed. Stent removal will then be performed at 8-weeks post-stent insertion.
The procedure will be done in the same manner with same endoscopic technique, stent deployment, and timing of stent removal. The only difference would be the lack of suturing and naturally the need for suture cutting at stent removal.