Clinical trial NCT06364553: Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
Official title: Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oesophageal Cancer
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complication: incidence of perforation
timeFrame: 6 months
measure: Complication: incidence of hemorrhage
timeFrame: 6 months
measure: Complication: incidence of fistula formation
timeFrame: 6 months
measure: Complication: incidence of gastroesophageal reflux
timeFrame: 6 months
measure: Complication: incidence of stent migration
timeFrame: 6 months
measure: Efficacy: clinical outcome
timeFrame: 6 months
measure: Efficacy: incidence of patients receiving technical successful stent placement
timeFrame: 1 day, during stent placement
Secondary outcomes:
measure: Incidence of recurrent dysphagia
timeFrame: 6 months
measure: Pain related to esophageal stent (placement)
timeFrame: 6 months
measure: Overall survival
timeFrame: 6 months
Other outcomes:
measure: Patient characteristic: age
timeFrame: 1 day, at stent placement
measure: Patient characteristic: gender
timeFrame: 1 day, at stent placement
measure: Patient characteristic: tumor location
timeFrame: 1 day, during stent placement
measure: Patient characteristic: tumor histology
timeFrame: 1 day, checking PA records
measure: Stent characteristic: length of the stent
timeFrame: 1 day, during stent placement
measure: Stent characteristic: diameter of the stent
timeFrame: 1 day, during stent placement
measure: Patient characteristic: prior radiotherapy
timeFrame: 1 day, before stent placement
measure: Patient characteristic: prior chemotherapy
timeFrame: 1 day, before stent placement
Locations:
Study officials:
References: