Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esophageal self-expandable metal stent.
- Who it may be relevant to
- Registry conditions: Oesophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.
Detailed description
Objective: To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.
Study design: Single center prospective observational non-randomized clinical study.
Study population: A total of 20 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.
Interventions
- Device Esophageal self-expandable metal stent
The Leufen Esophageal aixstent ® (Leufen Medical GmbH) is indicated for the treatment of malignant esophageal strictures and postoperative stenosis. It is comprised of two components: an implantable metallic stent and the delivery system. After the procedure, the stent remains at the intended location, within the patient while the delivery system is removed.
Primary outcome measures
- Complication: incidence of perforation [Time frame: 6 months]
- Complication: incidence of hemorrhage [Time frame: 6 months]
- Complication: incidence of fistula formation [Time frame: 6 months]
- Complication: incidence of gastroesophageal reflux [Time frame: 6 months]
- Complication: incidence of stent migration [Time frame: 6 months]
- Efficacy: clinical outcome [Time frame: 6 months]
- Efficacy: incidence of patients receiving technical successful stent placement [Time frame: 1 day, during stent placement]
Secondary outcome measures (3)
- Incidence of recurrent dysphagia [Time frame: 6 months]
- Pain related to esophageal stent (placement) [Time frame: 6 months]
- Overall survival [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
- Requiring treatment for dysphagia (Ogilvie score of 2-41);
- Life expectancy of less than 12 months;
- Written informed consent;
- Age ≥ 18 years.
Exclusion criteria
- Stenosis after laryngectomy;
- Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- Tumor length of more than 14 cm;
- Previous stent placement for the same condition;
- Coagulopathy (not corrected prior to stent placement);
- Patients with eosinophilic esophagitis or an esophageal motility disorder;
- Nickel titanium (Nitinol) allergy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT06364553 · NL86416.078.24