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
Qualifiers
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
Treatments tested in this trial
- Esophageal self-expandable metal stent
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov