Clinical trial · Interventional
Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer. PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastrointestinal Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| management of therapy complications | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in health-related quality of life from baseline to 30 days and 3 months after self-expanding plastic stent or self-expanding metal stent placement
Secondary outcomes (5)
- measure
- Cost effectiveness of each type of stent
- measure
- Degree and duration of improvement of dysphagia
- measure
- Stent-related morbidities
- measure
- Time to event (time until first complication)
- measure
- Overall rate of mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary cancer of the esophagus or gastroesophageal junction * Squamous cell or other type * Diagnosis of malignant dysphagia * Disease deemed surgically inoperable, but may be any of the following: * Locally contained * Locally advanced * Metastatic * Unresponsive to previous chemoradiotherapy * Recurrent despite previous surgical resection * Must be either an inpatient OR outpatient at Johns Hopkins Hospital * No known tracheal compression by tumor burden PATIENT CHARACTERISTICS: * Karnofsky performance status 50-100% * Life expectancy ≥ 6 months * Platelet count \> 50,000/mm³ * INR \< 1.5 PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior surgery, chemotherapy, biologic therapy, or radiotherapy allowed * No concurrent surgery, chemotherapy, biologic therapy, or radiotherapy
References
Publications (0)
Data not yet available