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

Phase 2

• Conditions: Malignant Airway Obstruction
• Interventions: Device: Traditional airway stent; Drug: Iodine-125 seeds

• Registration Number: NCT02565927
• Lead Sponsor: Zhongda Hospital

Brief 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.

Detailed Description

Malignant tumors of the lung, esophagus, thyroid, or other mediastinal structures often involve the trachea by direct tumor growth compression and (or) invasion. In addition, extrathoracic cancers metastasize to these lymph nodes as well. However, surgical resection and airway reconstruction are the gold-standard treatment for MAO, many patients with airway involvement are poor surgical candidates based on physiologic or oncologic criteria.There are three main types of malignant airway obstruction: endobronchial obstruction, extrinsic compression, and a mixed pattern. For endobronchial obstruction, ablative techniques that destroy tissue are indicated, including lasers, electrocautery, argon plasma coagulation (APC), photodynamic therapy, microdebriders, and cryotherapy, but primary tracheal cancers are less common than other types of lung cancer. If the obstruction is exclusively or mainly due to compression from outside the airway wall, the only option consists of placement of a stent or endoprosthesis. However, follow-up data has demonstrated that postoperative restenosis of stenting occurs in 5-45% of cases as a result of neoplastic infiltration through the mesh into the lumen or tumor overgrowth above and below the mesh stents. Encouraged by the success of 125I esophageal and biliary stent in esophageal carcinoma , a tracheal stent loaded with 125I radioactive seeds was developed in investigators'institute. After successful in vitro and in vivo evaluations of the delivery system, investigator will prospectively compare responses to treatment with this irradiation tracheal stent versus the conventional self-expandable stent in patients with MAO.

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-20
• Study First Submitted QC: 2015-09-29
• Last Update Submitted: 2015-09-29
• Study First Posted: 2015-10-01
• Last Update Posted: 2015-10-01
• Primary Completion: 2016-08
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional airway stent	Traditional airway stent	Patients diagnosed as MAO treated with traditional airway stent
Radioactive stent	Traditional airway stent	Patients diagnosed as MAO treated with radioactive airway stent loaded with Iodine-125 seeds
Radioactive stent	Iodine-125 seeds	Patients diagnosed as MAO treated with radioactive airway stent loaded with Iodine-125 seeds

Primary Outcome Measures

Name	Time	Method
diameter stenosis	Participants will be followed till die or lost to follow-up,an expected average of a year.	reference tracheal diameter minus minimum diameter at stenosis site / reference tracheal diameter×100

Secondary Outcome Measures

Name	Time	Method
Over survival	Participants will be followed till die or lost to follow-up,an expected average of a year.	Time from stenting to the day when the patients died or lost to the follow-up.

Trial Locations

Locations (1)

Zhongda Hospital,Southeast University; 🇨🇳 Nanjing, Jiangsu, China