NCT03186014

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer related mortality worldwide. Most patients have lost chance of surgical resection when they are initially diagnosed, because of late stage cancer or metastasis. Dysphagia is the major symptom of patients with advanced esophageal cancer. The two most commonly used strategies for relieving the dysphagia are stent placement and intraluminal brachytherapy. Stent placement provides a fast improvement of dysphagia, while intraluminal brachytherapy provides a more durable effect on dysphagia. To combine the advantages of the immediate relief of esophageal dysphagia with stent placement and long-term benefit with brachytherapy, a novel irradiation stent loaded with 125I seeds has been developed in the authors' institute. Recently, a multicentre randomized clinical trial demonstrated this novel irradiation stent can relieve the dysphagia rapidly and prolong the survival of patients with advanced esophageal cancer. However, this irradiation stent only provides a slightly longer relief of dysphagia and cannot reduce the total stent stenosis rate, because partly covered stent with uncoated flanges on both ends for anchoring the stent are used. In the past few years, fully covered retrievable stents which allow less tissue overgrowth have been used in patients with longer life expectancy, especially if they are receiving additional palliative therapy like brachytherapy. In order to provide a further longer relief of dysphagia and prevent stent migration caused by tumor regresses with brachytherapy, a fully covered segmented retrievable irradiation stent has been developed. The aim of the current study is to evaluate the clinical efficacy, particularly focus on stent stenosis and stent migration, and safety of this newly developed irradiation stent in patients with unresectable malignant dysphagia.

Conditions

• Malignant Dysphagia

Interventions

Type	Name	Description
DEVICE	Fully covered irradiation stent	A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-06-14
• Last updated: 2017-06-14

Locations

1 site across 1 country: China