A Trail of a Novel Tracheal Radioactive Stent for the Malignant Airway Obstruction

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to evaluate the safety and effectiveness of an radioactive airway stent loaded with 125I seeds compared to a conventional airway stent in patients with malignant airway obstruction caused by both primary and metastatic malignant tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhongda Hospital

Criteria

Inclusion Criteria:

1. aged between 18 and 80 years

2. MAO caused by any adenocarcinoma with histologically or cytologically confirmation by biopsy or previous surgical procedures

3. symptoms such as dyspnea related to biliary obstruction

4. unresectability or refusal to be surgically treated

5. willing and able to comply with the study procedures and provide written informed consent to participate

Exclusion Criteria:

1. patients with suspected benign airway obstruction

2. airway obstruction that could not be dilated enough to pass the delivery system

3. perforation of any ducts within the tracheal tree

4. presence of metallic tracheal stent or airway surgery

5. acute or chronic inflammation in the airway

6. uncooperative or could not provide authorization and signature.