A new design metal stent, SX-Ella stent Esophageal HV, for the prevention of recurrent dysphagia due to migration or tissue overgrowth: a prospective follow-up study

A new design metal stent, SX-Ella stent Esophageal HV, for the prevention of recurrent dysphagia due to migration or tissue overgrowth: a prospective follow-up study - SX-ELLA stent Esophageal HV for the prevention of recurent dysphagia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30726

Enrollment

Registered

2007-03-16

Start date

2007-02-14

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Maligne obstruction esophagus obstructive esophageal cancer

Interventions

Endoscopic esophageal stent placement

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a.Inoperable malignant obstruction of the esophagus or cardia (a tumor is considered inoperable if the patient has local tumor infiltration in neighboring organs, distant metastases, or a poor general health due to serious concomitant disease). b.Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal cancer. c.Signed informed consent.

Exclusion criteria

Exclusion criteria: a.Evidence of tumor within 2 cm of the upper esophageal sphincter. b.Esophagotracheal or -bronchial fistula or both. c.Lesions longer than 12 cm. d.WHO performance score of 4. e.Lack of fitness for sedation (including known allergies).

Design outcomes

Primary

Measure	Time frame
- Primary endpoint is the occurrence of recurrent dysphagia (stent migration, tissue overgrowth) including the need for re-intervention.	—

Secondary

Measure	Time frame
- Secondary endpoints are functional outcome (dysphagia score), the occurrence of complications and survival.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)