TTS Esophageal HILZO Stent: A Safety and Feasibility Study

Study Overview
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Brief Summary
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A multicenter non-randomized prospective clinical study assessing the safety and feasibility of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for palliation of malignant dysphagia

Detailed Description
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The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. Other (secondary) objects are to assess the effect of the stent on the presence of hyperplastic reaction after implantation, the functional complications and survival.

Official Title
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TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Device: HILZO esophageal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease. OR Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer. Requiring treatment for dysphagia (dysphagia score of ≥ 2, according to Ogilvie2) Written informed consent Age ≥ 18 years Exclusion Criteria: Inappropriate cultural level and understanding of the study. Simultaneous participation in another clinical study Life expectancy of less than 12 months Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter Tumor length of more than 12cm Previous stent placement for the same condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients with malignant dysphagia treated with the HILZO stent | Device: HILZO esophageal stent<br>* A fully covered esophageal self-expandable metal stent for malignant dysphagia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment associated adverse events during follow-up (safety) | Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux. | 1 year | 
| Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location | Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location. | 1 day | 
| Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement | Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome) | Ogilvie dysphagia score measured at: baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up. | 6 months | 
| Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome) | Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale. Measurements will take place at 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up | 6 months |