Malignant esophageal stenosis, malignant esophageal stricture Malignant esophageal stricture
Conditions
Interventions
All patients will be treated with the esophageal self-expandable nitinol stent
(Leufen Esophageal aixstent®).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients presenting with dysphagia due to an incurable malignant obstruction of the distal esophagus (>24cm) or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients; - Requiring treatment for dysphagia (Ogilvie score of 2-4); - Life expectancy of less than 12 months; - Written informed consent; - Age >= 18 years;
Exclusion criteria
Exclusion criteria: - Stenosis after laryngectomy; - Tumor at a distance of <24cm from incisors; - Tumor length of more than 14 cm; - Previous stent placement for the same condition; - Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the baseline procedure (low-dose aspirin (max. 100 mg/day) may be continued); - Known clotting disorder that cannot be corrected pre-procedural; - Esophageal varices; - Disorders of the physiological swallowing function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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, hemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening, moderately severe pain or gastroesophageal reflux and stent migration. - Efficacy: Consisting of: • Clinical outcome, measured at baseline and during follow-up until death with the Ogilvie dysphagia score; •Technical successful placement of the esophageal partially covered SEMS including correct positioning at the stenosis. Technical success is defined as ease of deployment and placement of the stent at the required location. All primary study parameters will be compared to our historical stent cohort consisting of 997 patients that underwent self-expandable metal stent placement due to an incurable esophageal stricture from July 1994 to May 2017. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recurrent dysphagia: cause of dysphagia will be registered during follow-up; - Pain related to esophageal stent during follow-up: the first two weeks pain will be measured daily with a patient diary, using the Visual Analogue Scale (VAS). After this, every 4 weeks until death the patient will be contacted with a telephone interview; - Overall survival. All secundary study parameters will be compared to our historic stent cohort consisting of 997 patients that underwent self-expandable metal stent placement due to an incurable esophageal stricture from July 1994 to May 2017. | — |
Countries
Netherlands
Contacts
Public ContactA.D.I. Maan
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed