WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture (E7025)

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

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 Overview

• Status: Completed
• Conditions: Refractory Anastomotic Esophageal Strictures
• Intervention / Treatment: Device: WallFlex Esophageal RX Fully Covered Stent; Device: Esophageal Bougie Dilator Per Investigator preference

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05612-000
    • Instituto do Cancer do Estado de Sao Paulo
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • CE
    • Rotterdam, CE, Netherlands, 3015
      • Erasmus Medical Center
• Sweden
  • Stockholm, Sweden, S-14186
    • Karolinska Universitets Sjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Metal Stent; 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; 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
ACTIVE_COMPARATOR: Bougie Dilation; 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; Commercially available Esophageal Bougie Dilator Per Investigator preference

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Peter D. Siersema, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 23, 2013
• Primary Completion (ACTUAL): September 25, 2016
• Study Completion (ACTUAL): September 25, 2016

Study Registration Dates

• First Submitted: October 2, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (ESTIMATE): October 3, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Refractory Anastomotic esophageal strictures
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis
• Other Study ID Numbers: 90913904