Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02565927
Recruitment Status : Unknown
Verified September 2015 by Gao-jun Teng, Zhongda Hospital.
Recruitment status was:  Recruiting
First Posted : October 1, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, 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.

Condition or disease Intervention/treatment Phase
Malignant Airway Obstruction Device: Traditional airway stent Drug: Iodine-125 seeds Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking
Drug Information available for: Iodine

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 Name: Tracheal stent(Nanjing MicroInvasive Medical Inc.)

Drug: Iodine-125 seeds
process intraluminal brachytherapy
Other Name: 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 Name: Tracheal stent(Nanjing MicroInvasive Medical Inc.)




Primary Outcome Measures :
  1. diameter stenosis [ Time Frame: 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 :
  1. Over survival [ Time Frame: 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.


Other Outcome Measures:
  1. Success rate [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    The rate of relief of the symptoms and signs of the patients

  2. Number of participants with abnormal laboratory values that are telated to treatment [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    laboratory examination of white blood cells, IgA, IgG and IgM.

  3. Number of participants with adverse events that are telated to treatment [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    Adverse events as follows: severe chest pain, hemoptysis, perforation, pneumonia

  4. dyspnea index [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565927


Contacts
Layout table for location contacts
Contact: Yong Wang, Ph.D medicalusing@163.com

Locations
Layout table for location information
China, Jiangsu
Zhongda Hospital,Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Yong Wang, Ph.D         
Sponsors and Collaborators
Zhongda Hospital
Investigators
Layout table for investigator information
Principal Investigator: Gao-jun Teng, Ph.D,MD Zhongda Hospital Southeast University

Layout table for additonal information
Responsible Party: Gao-jun Teng, Director of Department of Interventional Radiology & Vascular Surgery, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT02565927    
Other Study ID Numbers: 2015ZDSYLL032.0
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Keywords provided by Gao-jun Teng, Zhongda Hospital:
Trachea
Stent
Intraluminal brachytherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs