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

Recruiting

• Conditions: Maligne obstruction esophagus; obstructive esophageal cancer; 10018008

• Registration Number: NL-OMON30726
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Primary endpoint is the occurrence of recurrent dysphagia (stent migration,<br /><br>tissue overgrowth) including the need for re-intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Secondary endpoints are functional outcome (dysphagia score), the occurrence<br /><br>of complications and survival. </p><br>