Clinical trial · Interventional
Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer
Phase IV Study of Self-Expandable Esophageal Stent Loaded With 125I Seeds: a Randomized Controlled Multiple Center Trial in Patients With Advanced Esophageal Cancer
- 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)
More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophageal stent placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- stenting
- description
- The conventional esophageal stent or 125I radiation stent is placed in the patients with dysphagia who are enrolled to the study.
- interventionNames
- Device: Esophageal stent placement
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Death of the patient
Secondary outcomes (3)
- measure
- Quality of life
- timeFrame
- 3, 6, 12 months
- measure
- Restenosis of the stent
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, * Without esophageal fistulas, * Must be an inpatient, * 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 after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
References
Publications (2)
- BACKGROUNDGuo JH, Teng GJ, Zhu GY, He SC, Fang W, Deng G, Li GZ. Self-expandable esophageal stent loaded with 125I seeds: initial experience in patients with advanced esophageal cancer. Radiology. 2008 May;247(2):574-81. doi: 10.1148/radiol.2472070999. Epub 2008 Mar 18. PMID 18349316
- 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