A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia
NCT03186014 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2017-06-14
Summary
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
- Malignant Dysphagia
Interventions
- DEVICE
-
Fully covered irradiation stent
A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia
Sponsors & Collaborators
-
Zhongda Hospital
lead OTHER
Principal Investigators
-
Gao-jun Teng, Ph.D,MD · Zhongda Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-30
- Primary Completion
- 2018-10-31
- Completion
- 2018-10-31
Countries
- China
Study Locations
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