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

Malignant Airway Obstruction Clinical Trial

Official title:

A Novel Tracheal Radioactive Stent Loaded With 125I Seeds for the Malignant Airway Obstruction Versus a Conventional Stent: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565927
• Other study ID #: 2015ZDSYLL032.0
• Status: Recruiting
• Phase: Phase 2
• First received: September 20, 2015
• Last updated: September 29, 2015
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: Zhongda Hospital
• Contact: Yong Wang, Ph.D
• Email: medicalusing[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Malignant Airway Obstruction

Intervention

Device:
• Traditional airway stent
process airway stenting

Drug:
• Iodine-125 seeds
process intraluminal brachytherapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Success rate	The rate of relief of the symptoms and signs of the patients	Participants will be followed till die or lost to follow-up,an expected average of a year.	Yes
Other	Number of participants with abnormal laboratory values that are telated to treatment	laboratory examination of white blood cells, IgA, IgG and IgM.	Participants will be followed till die or lost to follow-up,an expected average of a year.	Yes
Other	Number of participants with adverse events that are telated to treatment	Adverse events as follows: severe chest pain, hemoptysis, perforation, pneumonia	Participants will be followed till die or lost to follow-up,an expected average of a year.	Yes
Other	dyspnea index	Dyspnea index grades are as follows: grade 0,asymptomatic while climbing stairs; grade I, symptomatic climbing stairs; grade II, symptomatic after walking 100 m on flat ground; grade III, symptomatic with the least effort (talking,getting dressed); and grade IV, symptomatic in bed, at rest.	Participants will be followed till die or lost to follow-up,an expected average of a year.	Yes
Primary	diameter stenosis	reference tracheal diameter minus minimum diameter at stenosis site / reference tracheal diameter×100	Participants will be followed till die or lost to follow-up,an expected average of a year.	No
Secondary	Over survival	Time from stenting to the day when the patients died or lost to the follow-up.	Participants will be followed till die or lost to follow-up,an expected average of a year.	Yes