Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Oesophageal Cancer
- Sponsor
- Erasmus Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Efficacy: incidence of patients receiving technical successful stent placement
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Peter Siersema
Prof. dr.
Erasmus Medical Center
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.
Outcomes
Primary Outcomes
Efficacy: incidence of patients receiving technical successful stent placement
Time Frame: 1 day, during stent placement
Technical successful stent placement will be measured during stent placement whether the stent is in the correct position (covering the whole stenosis) and is described as yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of perforation
Time Frame: 6 months
The complication perforation during stent placement and during follow-up will be measured using patient anamneses and if necessary upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of hemorrhage
Time Frame: 6 months
The complication hemorrhage will be measured during stent placement and follow-up using patient anamneses and if necessary with an upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of fistula formation
Time Frame: 6 months
The complication fistula formation will be measured during stent placement and during follow-up using patient anamneses and if necessary with an upper endoscopy and is described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of gastroesophageal reflux
Time Frame: 6 months
The complication gastroesophagel reflux will be measured after stent placement with the use of patient anamneses and will be described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of stent migration
Time Frame: 6 months
The complication stent migration will be measured using a new upper endoscopy in case there is recurrent dysphagia (measured with the Ogilvie Dysphagia score from 0 = no dysphagia to 4 = inability to swallow food or liquids, so the higher te score, the worse the outcome) and described as present yes or no. After all patients are included, the incidence can be described as percentage.
Efficacy: clinical outcome
Time Frame: 6 months
The clinical outcome will be measured using the Ogilvie Dysphagia Score to determine whether recurrent dysphagia is present after stent placement during follow-up or until death. The Ogilvie Dysphagia Score is a score ranging from 0 = no dysphagia to 4 = inability to swallow any food or liquids, so the higher te score, the worse the outcome.
Secondary Outcomes
- Incidence of recurrent dysphagia(6 months)
- Pain related to esophageal stent (placement)(6 months)
- Overall survival(6 months)