Safety and efficacy of a biodegradable stent during neoadjuvant therapy in patients with advanced esophageal cancer.

Safety and efficacy of a biodegradable stent during neoadjuvant therapy in patients with advanced esophageal cancer. - EsNeBio.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36667

Enrollment

Registered

2011-11-02

Start date

2011-10-31

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

esophageal cancer

Interventions

Endoscopic placement of a biodegradable esophageal stent.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * cT1-3 N0-1 M0 esophageal carcinoma. * Scheduled for neoadjuvant chemoradiation therapy prior to esophagectomy. * Dysphagia for solid, semisolid or liquid food (dysphagia score 2, 3, 4). * Age older then 18 years. * Informed consent.

Exclusion criteria

Exclusion criteria: * Tumor length of more than 10 cm. * Tumor growth within 5 cm of the upper esophageal sphincter. * Tumor extension into the stomach more than 5 cm. * Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments.

Design outcomes

Primary

Measure	Time frame
Primary outcome measure is safety.	—

Secondary

Measure	Time frame
Secondary outcome measures are clinical succes, technical success, persistent or recurrent dysphagia, complications and weight changes.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)