Clinical trial · Interventional
A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia
A Novel Fully Covered Segmented Irradiation Stent Loaded With 125I Seeds for the Palliation of Malignant Dysphagia：a Prospective Pilot Study
- 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)
Dysphagia is the major symptom of patients with malignant esophageal stricture caused predominantly by advanced esophageal cancer. Stent placement is the most commonly used strategies for relieving the dysphagia and a novel irradiation stent loaded with 125I seeds has recently been developed. A multicentre randomized clinical trial demonstrated this irradiation stent can relieve the dysphagia rapidly and prolong the survival of patients with advanced esophageal cancer, but the total stent stenosis rate cannot be ruduced. A novel fully covered segmented retrievable irradiation stent was developed in our institute. The purpose of this study is to evaluate the safety and clinical efficacy of this newly developed irradiation stent in patients with unresectable 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 |
|---|---|---|---|
| Malignant Dysphagia | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fully covered irradiation stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fully covered irradiation stent
- description
- A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia
- interventionNames
- Device: Fully covered irradiation stent
Primary outcomes (1)
- measure
- Recurrent dysphagia
- timeFrame
- Participants will be followed till die or lost to follow-up, an expected average of 6 months.
- description
- The rate of occurrence of tissue ingrowth or overgrowth, stent migration, and food obstruction.
Secondary outcomes (9)
- measure
- Dysphagia score
- timeFrame
- Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Endoscopically and histologically confirmed malignant obstruction of the esophagus or the gastroesophageal junction * Progressive dysphagia with a dysphagia score of 2-4 * Unresectable tumours due to extensive lesions, metastases, or poor medical condition * Patients with clear consciousness, cooperation * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3 * Informed consent: authorization and signature Exclusion Criteria: * The superior border of the lesion extending beyond the level of the seventh cervical vertebrae * Previous treatment with a stent or surgical resection for the same condition * Ulcerative esophageal cancer * Esophageal fistula * Severe hepatic inadequacy or renal inadequacy
References
Publications (0)
Data not yet available