Clinical trial · Interventional
Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal Cancer
NCT00477841CI-TRIAL-00001410completedPhase 2ClinicalTrials.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)
To determine the response to treatment with a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy versus a conventional covered stent in patients with advanced esophageal cancer.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| complications of therapy | Procedure | — | UNRESOLVED |
| dysphagia scores | Procedure | — | UNRESOLVED |
| Esophageal stent placement | Procedure | — | UNRESOLVED |
| survival time of therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Relief of dysphagia measured by dysphagia scores, survival time from the interventional procedure to the last follow-up.
- timeFrame
- Follow-up in intervals of 1, 3, 6 and 12 months after stent placement
Secondary outcomes (1)
- measure
- Successful rate of stent placement, Stent-related complications and morbidity, Overall rate of mortality
- timeFrame
- Follow-up in intervals of 1, 3, 6, and 12 months after stent placement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary cancer of esophagus, * Must be dysphagia caused by esophageal cancer, * Surgically inoperable, but may be metastatic, * Without esophageal fistulas, * Must be an inpatient at Zhongda Hospital, * Life expectancy is over 6 months, Exclusion Criteria: * Esophageal fistulas, * Tracheal compression with symptoms, * WBC \<2000/mm3 and Platelet count \<50,000/mm3, * Concurrent therapies:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
References
Publications (1)
- BACKGROUNDGuo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7. PMID 17085003