A Phase 2 interventional study of FCSEMS with Endostitch (ES) and FCSEMS with No Suturing (NS) in Esophageal Strictures, Esophageal Leak and Esophageal Perforation, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
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.
The use of removable, fully covered self-expanding metal stents (FCSEMS) in the management of benign esophageal pathology has been increasingly applied in recent years. Several studies have shown promising results with its application in esophageal perforation, fistula, or leak, and refractory benign strictures. However, the major limiting factor to successful treatment with FCSEMS in this setting is the substantial migration rates.
Different strategies has been used to secure esophageal stents but to little success. Several tertiary institutions including investigators have adopted the use of endostitch (ES) with the OverStitchTM system (Apollo Endosurgery, Austin, Texas) as the preferred method for stent fixation. Animal ex-vivo studies have confirmed the greater anchoring ability and tensile strength with this method when compared to esophageal stenting alone or with through the endoscope clip fixation while retrospective series have shown promising results with lower rates of stent migration when compared to conventional stent insertion. However, although the use of endostitch stent fixation has been used in several centers in the United-States with strong retrospective data (including investigators data), no prospective randomized controlled trial have confirmed its effectiveness in preventing stent migration.
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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.
Procedure: FCSEMS with Endostitch (ES) · Device: Fully Covered Self-Expanding Metal Stents (FCSEMS) · Device: EndoStitch (ES) with the OverStitchTM system
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.
Procedure: FCSEMS with No Suturing (NS) · Device: Fully Covered Self-Expanding Metal Stents (FCSEMS)
The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.
The insertion of FCSEMS with no suturing.
This is the stent that will be used to treat the esophageal pathology in both groups
This is the device used to apply the stitches to the stent in participants randomized to stent suturing.
Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy.
Subjects returning to the hospital following stent placement with symptoms suggestive of stent migration such as fever, abdominal or chest pain, nausea/vomiting, and dysphagia with objective evidence of stent migration either on radiological imaging or endoscopy.
Time frame: Up to 6 months
Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia
Dysphagia relief as assessed by the validated dysphagia score
Time frame: 4 weeks, 6 months post-stent removal
Procedure time
Time required for stent placement with/without endostitch
Time frame: During procedure
Stent insertion complication rate
All complications related to stent insertion other than stent migration will be recorded with a preset questionnaire to measure the frequency of complications related to stent insertion.
Time frame: 3 days post-stent insertion, 4 weeks post-stent removal
Quality of life
Quality of life as measured by the SF-36 (Short Form health survey) questionnaire
Time frame: prior to stent insertion and 6 months post-stent removal
Ran from Mar 2016 to primary completion in Feb 2017, 11 months.
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