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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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
Commercially available Esophageal Bougie Dilator Per Investigator preference
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Erasmus Medical Center
Rotterdam, CE, Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
Karolinska Universitets Sjukhuset
Stockholm, Sweden
Number of Dilation Procedures
Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
Quality Of Life Overall Health Score
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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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Total Number of Stent Migrations
Total number of stent migrations with or without symptoms.
Time frame: 12 months
Number of Reinterventions Within 12 Months Following the Initial Study Treatment
Number of reinterventions within 12 months following the initial study treatment.
Time frame: 12 months