A Comparison of Two Expandable Metal Stents for the Palliation of Malignant Esophageal Disease

A Comparison of Two Expandable Metal Stents for the Palliation of Malignant Esophageal Disease - STEMA study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33264

Enrollment

Registered

2009-06-22

Start date

2009-06-26

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

malignant esophageal stenosis / esophageal narrowing and malignant esophageal fistulas

Interventions

• Insertion of the Ultraflex® Stent (group 1) or the Evolution® Controlled Release Stent (group 2)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients, 18 years of age and older, referred for stent placement for malignant esophageal disease

Exclusion criteria

Exclusion criteria: Location of lesions at less than 4 cm from upper gastro-intestinal sphincter. Lesions longer than 9 cm. Patients who are unable to undergo endoscopy

Design outcomes

Primary

Measure	Time frame
• To compare the reintervention rate	—

Secondary

Measure	Time frame
• To compare the procedural failure rate. • To compare the early functional failure rate. • To compare the procedure related complications. • To compare the recurrence rate of dysphagia / esophageal leakage • To compare the survival rate.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)