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Comparison of Two Expandable Endoprosthesis for Benign Esophageal Disease

Comparison of Two Expandable Endoprosthesis for Benign Esophageal Disease - CTEB - Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32797
Enrollment
40
Registered
2008-11-13
Start date
2008-11-17
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

non-malignant esophageal stenosis (esophageal narrowing)/ esophageal perforation (leak)

Interventions

stent insertion --> Ultraflex stent or Hanarostent

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Presence of an esophageal malignancy or extrinsic compression due to mediastinal malignancy. 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

Secondary

MeasureTime frame
o Technical outcome - defined as success of stent deployment at the required position. o Immediate functional outcome - defined as immediate clinical success in relief of dysphagia, or sealing of a perforation or fistula at 24 hours. o Re-intervention rate after stent removal. o Procedural complications. o Success of stent extraction. o Thirty-day mortality rate.

Primary

MeasureTime frame
The primary parameter of this study is the stent migration rate.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)