Endostitch, Esophageal Fistula, Esophageal Leak, Esophageal Perforation, Esophageal Stent, Esophageal Strictures
Conditions
Keywords
Esophageal stricture, Esophageal leak, Esophageal perforation, Esophageal fistula, Endostitch, Esophageal stent
Brief 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.
Detailed description
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.
Interventions
PROCEDUREFCSEMS with Endostitch (ES)
The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.
PROCEDUREFCSEMS with No Suturing (NS)
The insertion of FCSEMS with no suturing.
DEVICEFully Covered Self-Expanding Metal Stents (FCSEMS)
This is the stent that will be used to treat the esophageal pathology in both groups
DEVICEEndoStitch (ES) with the OverStitchTM system
This is the device used to apply the stitches to the stent in participants randomized to stent suturing.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients age 18 years and older 2. 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. 3. Patients with esophageal leak, perforation, or fistula referred for endoscopic stenting 4. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
1. Pediatric patients age under 18 years 2. Pregnant or breastfeeding patients 3. 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) 4. Benign strictures not having had two attempts at endoscopic dilation 5. Uncorrectable coagulopathy defined by partial thromboplastin time (PTT) greater than 50 sec, or international normalized ratio (INR) greater than 1.5 6. Uncorrectable thrombocytopenia with platelet count less than 50, 000
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy. | Up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia | 4 weeks, 6 months post-stent removal | Dysphagia relief as assessed by the validated dysphagia score |
| Procedure time | During procedure | Time required for stent placement with/without endostitch |
| Stent insertion complication rate | 3 days post-stent insertion, 4 weeks post-stent removal | 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. |
| Quality of life | prior to stent insertion and 6 months post-stent removal | Quality of life as measured by the SF-36 (Short Form health survey) questionnaire |
Countries
United States
Outcome results
None listed