Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal Cancer

Esophageal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477841
• Other study ID #: 320106196208052017
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2007
• Last updated: April 17, 2008
• Start date: April 2004
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the response to treatment with a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy versus a conventional covered stent in patients with advanced esophageal cancer.

Description:

Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. 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 technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The current study is designed to demonstrate the preliminary results with this irradiation stent in patients with inoperable esophageal cancer compared to those using a conventional covered stent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed primary cancer of esophagus,

• Must be dysphagia caused by esophageal cancer,

• Surgically inoperable, but may be metastatic,

• Without esophageal fistulas,

• Must be an inpatient at Zhongda Hospital,

• 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:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Esophageal stent placement

• dysphagia scores

• complications of therapy

• survival time of therapy

Locations

Country	Name	City	State
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

References & Publications (1)

Guo 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. Epub 2006 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of dysphagia measured by dysphagia scores, survival time from the interventional procedure to the last follow-up.		Follow-up in intervals of 1, 3, 6 and 12 months after stent placement
Secondary	Successful rate of stent placement, Stent-related complications and morbidity, Overall rate of mortality		Follow-up in intervals of 1, 3, 6, and 12 months after stent placement