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A RANDOMIZED COMPARISON OF DEGRADABLE ESOPHAGEAL STENT VS DILATION THERAPY: *DESTINY TRIAL* FOR PATIENTS WITH RECURRENT BENIGN ESOPHAGEAL STRICTURES

A RANDOMIZED COMPARISON OF DEGRADABLE ESOPHAGEAL STENT VS DILATION THERAPY: *DESTINY TRIAL* FOR PATIENTS WITH RECURRENT BENIGN ESOPHAGEAL STRICTURES - DESTINY TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35755
Enrollment
40
Registered
2011-11-02
Start date
2012-01-19
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysphagia Recurrent benign esophageal strictures

Interventions

Standard dilation therapy (balloon or bougie dilation) to 18 mm vs. placement of a degradable stent (SX-ELLA Stent Esophageal Degradable BD (Ella-CS, s.r.o., Czech Republic)) with a diameter of 18,

Sponsors

William Cook Europe ApS
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: recurrent dysphagia for solid, semisolid, or liquid food after 1-5 previous dilations, due to a confirmed benign esophageal stricture.

Exclusion criteria

Exclusion criteria: esophageal motility disorder, malignant stricture, previous stent placement and active leak, perforation or local infection.

Design outcomes

Primary

MeasureTime frame
Primary Objective: - The number of repeat endoscopic dilations within 3 and 6 months after degradable esophageal self-expanding stent placement to standard dilation therapy in patients with benign recurrent esophageal strictures—

Secondary

MeasureTime frame
Secondary Objectives: - Safety, quality of life, direct medical costs and patient satisfaction after degradable esophageal self-expanding stent placement to standard dilation therapy during 12 months in patients with benign recurrent esophageal strictures—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)