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A randomized comparison of a fully covered self expandable metal stent versus a partially covered self expandable metal stent in malignant esophageal strictures

A randomized comparison of a fully covered self expandable metal stent versus a partially covered self expandable metal stent in malignant esophageal strictures - COPAC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35282
Enrollment
72
Registered
2012-03-20
Start date
2012-08-01
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 stricture

Interventions

In one treatment group a fully covered metal stent will be placed. In the other treatment group a partially covered metal stent will be inserted.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Malignant stricture of the esophagus or cardia No curative treatment options available Dysphagia grade of at least 2 (able to swallow semi-solid soft foods) Informed consent Age * 18 years

Exclusion criteria

Exclusion criteria: Previous treatment with self-expandable metal stent for same condition Evidence of tumor within 2 cm of the upper esophageal sphincter. Presence of an esophago-tracheal or -bronchial fistula or both. Not able to undergo upper endoscopy

Design outcomes

Primary

MeasureTime frame
Recurrent dysphagia. This is defined as occurrence of dysphagia due to a stent or tumour related cause such as tumor in- or overgrowth, stent migration or food impaction.

Secondary

MeasureTime frame
Technical success of metal stent placement, clinical success defined as improvement of dysphagia score, complication rate, quality of life and survival

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)