N/A
N=18
WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture
Refractory Anastomotic Esophageal Strictures
Bottom Line
View on ClinicalTrials.gov: NCT01699542 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Jun 2021
Primary outcome: Primary: Number of Dilation Procedures — 5.4; 2.4 Dilation procedures — p=0.159
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WallFlex Esophageal RX Fully Covered Stent (Device); Esophageal Bougie Dilator Per Investigator preference (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Dilation Procedures |
5.4; 2.4 | 0.159 |
| SECONDARY Number of Participants With Technical Stent Placement Success |
9; 0 | — |
| SECONDARY Number of Participants With Technical Stent Removal Success |
9; 0 | — |
| SECONDARY Patient's Satisfaction With the Therapy |
8.0; 10.0; 8.0; 9.5; 9.0; 10.0 | — |
| SECONDARY Patient's Report of Pain |
0.0; 0.0; 3.0; 0.0; 1.0; 0.0 | — |
| SECONDARY Quality Of Life Overall Health Score |
70.0; 75.0; 70.0; 80.0; 80.0; 80.0 | — |
| SECONDARY Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure |
1; 0; 5; 0 | — |
| SECONDARY Time to Recurrence of Dysphagia |
36; 33 | — |
| SECONDARY Total Number of Stent Migrations |
2; 0 | — |
| SECONDARY Number of Reinterventions Within 12 Months Following the Initial Study Treatment |
5.6; 2.9 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01699542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.