Clinical trial · Interventional
Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
NCT06364553CI-TRIAL-00093295ENTRANCErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophageal self-expandable metal stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Esophageal self-expandable metal stent
- description
- Esophageal self-expandable metal stent
- interventionNames
- Device: Esophageal self-expandable metal stent
Primary outcomes (7)
- measure
- Complication: incidence of perforation
- timeFrame
- 6 months
- description
- 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.
- measure
- Complication: incidence of hemorrhage
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.