A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia

NCT ID: NCT03186014

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fully covered irradiation stent

A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia

Group Type: EXPERIMENTAL

Fully covered irradiation stent

Intervention Type: DEVICE

A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia

Interventions

Fully covered irradiation stent

A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao-jun Teng

Director of Department of Interventional Radiology & Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gao-jun Teng, Ph.D,MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chao Wang, Ph.D

Role: CONTACT

wangchaoseu@126.com

+86 151 9585 3100

Facility Contacts

Chao Wang

Role: primary

wangchaoseu@126.com

Other Identifiers

2017ZDSYLL027

Identifier Type: -

Identifier Source: org_study_id