Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
ConditionOesophageal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Esophageal self-expandable metal stent
DeviceThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Esophageal self-expandable metal stentOther 1 intervention
Trial outcomes
Primary outcomes
1
Complication: incidence of perforation
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.
Time frame
6 months2
Complication: incidence of hemorrhage
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.
Time frame
6 months3
Complication: incidence of fistula formation
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.
Time frame
6 months4
Complication: incidence of gastroesophageal reflux
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.
Time frame
6 monthsSecondary outcomes
1
Incidence of recurrent dysphagia
Recurrent dysphagia will be asked from the patient and will be measured with the Ogilvie Dysphagia score (ranging from 0 = no dysphagia to 4 = inability to swallow any food or liquids, so the higher te score, the worse the outcome). After all patients are included, the incidence can be described as percentage.
Time frame
6 months2
Pain related to esophageal stent (placement)
Pain related to esophageal stent (placement) measured daily using a patient diary which scores the Visual Analogue Scale (ranging from 0 = no pain to 10 = the worst pain imaginable, so the higher the score, the worse the outcome) during the first two weeks, after this every 4 weeks a telephone call with the patient will be held to discuss pain using the Visual Analogue Scale as well until death/stent removal, or until a maximum of 6 months follow-up)
Time frame
6 months3
Overall survival
Overall survival measured in days
Time frame
6 monthsOther outcomes
1
Patient characteristic: age
Patient age at baseline, so at the day of stent placement, measured in years
Time frame
1 day, at stent placement2
Patient characteristic: gender
Patient gender at baseline, at the day of stent placement, measured as male or female
Time frame
1 day, at stent placement3
Patient characteristic: tumor location
Location of the tumor in the esophagus, measured in cm from incisors during stent placement
Time frame
1 day, during stent placement4
Patient characteristic: tumor histology
Histology of the tumor in the esophagus, measured from biopsy results from upper endoscopies perfomed prior to the stent placement
Time frame
1 day, checking PA recordsSponsors and contacts
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Source ClinicalTrials.gov