Clinical trial NCT01699542: WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Anastomotic Esophageal Strictures
Keywords: Refractory Anastomotic esophageal strictures
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Dilation Procedures
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Technical Stent Placement Success
timeFrame: 12 months
measure: Number of Participants With Technical Stent Removal Success
timeFrame: 12 months
measure: Patient's Satisfaction With the Therapy
timeFrame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
measure: Patient's Report of Pain
timeFrame: Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
measure: Quality Of Life Overall Health Score
timeFrame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
measure: Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure
timeFrame: 12 months
measure: Time to Recurrence of Dysphagia
timeFrame: 12 months
measure: Total Number of Stent Migrations
timeFrame: 12 months
measure: Number of Reinterventions Within 12 Months Following the Initial Study Treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: CE
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Stockholm
country: Sweden
facility: Karolinska Universitets Sjukhuset
Study officials:
affiliation: Study Principal Investigator
name: Peter D. Siersema, MD
role: PRINCIPAL_INVESTIGATOR
References: