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

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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Airway Obstruction
• Intervention / Treatment: Device: Traditional airway stent; Drug: Iodine-125 seeds

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital，Southeast University
      • Contact: Yong Wang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radioactive stent; Patients diagnosed as MAO treated with radioactive airway stent loaded with Iodine-125 seeds	Device: Traditional airway stent; process airway stenting; Other Names: Tracheal stent(Nanjing MicroInvasive Medical Inc.); Drug: Iodine-125 seeds; process intraluminal brachytherapy; Other Names: Radioactive seeds(Chinese Atomic Energy Science Institution)
Active Comparator: Traditional airway stent; Patients diagnosed as MAO treated with traditional airway stent	Device: Traditional airway stent; process airway stenting; Other Names: Tracheal stent(Nanjing MicroInvasive Medical Inc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-jun Teng, Ph.D,MD, Zhongda Hospital Southeast University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: September 20, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Stent; Trachea; Intraluminal brachytherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 2015ZDSYLL032.0