WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

Study Overview
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Brief Summary
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The purpose of this of this study is to compare the safety and effectiveness of temporary indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of refractory anastomotic esophageal strictures

Official Title
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A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures

Conditions
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Refractory Anastomotic Esophageal Strictures

Intervention / Treatment
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* Device: WallFlex Esophageal RX Fully Covered Stent
* Device: Esophageal Bougie Dilator Per Investigator preference


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures). Esophagectomy performed at the same institution where patient enrollment and follow-up is planned. Two dilations to at least 16 mm in diameter since esophagectomy. 1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6 months of 1st dilation to 16mm. Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline. Unable to pass a standard endoscope (approx. 9.8 mm diameter). Age 18 years or older. Willing and able to comply with the study procedures and provide Exclusion Criteria:Stricture within 2 cm of the upper esophageal sphincter. Dysphagia related to motility disorder. Non-anastomotic esophageal strictures. Esophagocolonic strictures. Planned adjuvant radiation therapy post esophagectomy. Prior esophageal stent placements post esophagectomy. Active erosive esophagitis. Sensitivity to any components of the stent or delivery system. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study. Stricture length > 5 cm.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metal Stent<br>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures. | Device: WallFlex Esophageal RX Fully Covered Stent<br>* Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell<br>|
| Active Comparator: Bougie Dilation<br>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures. | Device: Esophageal Bougie Dilator Per Investigator preference<br>* Commercially available Esophageal Bougie Dilator Per Investigator preference<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Dilation Procedures | Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Technical Stent Placement Success | Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture. | 12 months | 
| Number of Participants With Technical Stent Removal Success | Technical stent removal success is defined as the ability to remove the stent without complications. | 12 months | 
| Patient's Satisfaction With the Therapy | Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome). | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 | 
| Patient's Report of Pain | Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome). | Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 | 
| Quality Of Life Overall Health Score | Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome. | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 | 
| Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure | Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure. | 12 months | 
| Time to Recurrence of Dysphagia | Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture. | 12 months | 
| Total Number of Stent Migrations | Total number of stent migrations with or without symptoms. | 12 months | 
| Number of Reinterventions Within 12 Months Following the Initial Study Treatment | Number of reinterventions within 12 months following the initial study treatment. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Anastomotic esophageal strictures