WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

Not Applicable

Completed

• Conditions: Refractory Anastomotic Esophageal Strictures
• Interventions: Device: WallFlex Esophageal RX Fully Covered Stent; Device: Esophageal Bougie Dilator Per Investigator preference

• Registration Number: NCT01699542
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-03
• Study Start: 2013-12-23
• Primary Completion: 2016-09-25
• Study Completion: 2016-09-25
• Status Verified: 2021-04
• Results First Submitted: 2021-05-10
• Results First Submitted QC: 2021-06-04
• Last Update Submitted: 2021-06-04
• Results First Posted: 2021-06-28
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metal Stent	WallFlex Esophageal RX Fully Covered Stent	The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
Bougie Dilation	Esophageal Bougie Dilator Per Investigator preference	Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.

Primary Outcome Measures

Name	Time	Method
Number of Dilation Procedures	12 months	Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Technical Stent Placement Success	12 months	Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.
Number of Participants With Technical Stent Removal Success	12 months	Technical stent removal success is defined as the ability to remove the stent without complications.
Patient's Satisfaction With the Therapy	Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12	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).
Patient's Report of Pain	Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12	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).
Quality Of Life Overall Health Score	Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12	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.
Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure	12 months	Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.
Time to Recurrence of Dysphagia	12 months	Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.
Total Number of Stent Migrations	12 months	Total number of stent migrations with or without symptoms.
Number of Reinterventions Within 12 Months Following the Initial Study Treatment	12 months	Number of reinterventions within 12 months following the initial study treatment.

Trial Locations

Locations (4)

Erasmus Medical Center; 🇳🇱 Rotterdam, CE, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Karolinska Universitets Sjukhuset; 🇸🇪 Stockholm, Sweden

Instituto do Cancer do Estado de Sao Paulo; 🇧🇷 Sao Paulo, Brazil