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出境医 / 临床实验 / A Metal Bare Stent With 125 Iodine （125I）Seeds for the Treatment of Malignant Central Airway Stenosis

A Metal Bare Stent With 125 Iodine （125I）Seeds for the Treatment of Malignant Central Airway Stenosis

Study Description
Brief Summary:
Malignant central airway stenosis caused by primary or metastatic malignant tumor may lead to dyspnea even death of patients.With the rapid development of interventional pulmonology, bronchoscopic therapy has become the main treatment for malignant central airway stenosis. Metal stent implantation in airway can quickly relieve respiratory obstruction and improve quality of life.However, the tumor tissue can continue to grow into metal stent and obstruct airway again. This is the shortcoming of metal bare stents, which often need further treatment to keep airway open, including ablation, laser, cryotherapy, external radiotherapy or systemic anti-tumor drug therapy.Metal stent implantation combined with external radiotherapy can effectively reduce the incidence of airway restenosis.However, complications of external radiotherapy are high, including bone marrow suppression, radioactive pneumonia, radioactive esophagitis, myocardial injury and tracheoesophageal fistula, of which may cause serious consequences and even cause death of the patient.125I radioactive seeds have been one of the mature radioactive interventional therapy, which release X rays, and γ rays. Because of the short radioactive distance, 125I seeds can destruct tumor cells in tumor site and promote apoptosis and necrosis of tumor cells around the obstruction of the airway, meanwhile cause little damage to the surrounding normal tissues. Some studies showed that 125I seed implantation of lung tumor lesions achieved good short-term results.Therefore, the investigators hypothesize that 125I seeds fixed on the metal bare stent can not only improve the patient's breathing difficulties, but also play a role in killing tumor cells. At present, there have been reports of related clinical cases and monocentric control studies of malignant central airway stenosis treated with the implantation of metal stent with 125I seeds, but there is a lack of multicentric clinical studies with large samples.

Condition or disease Intervention/treatment Phase
Malignant Airway Obstruction Procedure: stent implantation Not Applicable

Detailed Description:
It is an open, multicentric randomized controlled clinical trial conducted in China, and plan to recruiting 200 patients who suffer malignant central airway stenosis. To evaluate the efficacy and safety of metal stent with 125I seeds group and metal bare stent group in the treatment of malignant central airway stenosis, follow-up should be done within 1 week, 1 month, and 3 months after the first treatment, followed by every 3 months. The contents include review of bronchoscopy and chest CT, blood routine, immune indicators (IgA, immunoglobulin M（Ig M）, IgG), evaluation of general conditions. The patients of the first group need emission-computed tomography（ECT） imaging or positron emission tomography-computed tomography （PET-CT） examination within 1 month. If the patient has severe dyspnea, emergency bronchoscopy should be performed .
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of a Metal Bare Stent With 125I Seeds for the Treatment of Malignant Central Airway Compared to a Metal Bare Stent: A Multicentric Randomized Controlled Study.
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : February 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: A metal bare stent with 125I seeds
125I seeds fixed on the metal bare stent, then stent implantation
 Procedure: stent implantation
stent implantation
A metal bare stent
A metal bare stent implantation
 Procedure: stent implantation
stent implantation
Outcome Measures
Primary Outcome Measures :
  1. stenosis grade [ Time Frame: the first month after stent implantation ]

    Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0

    = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction


  2. stenosis grade [ Time Frame: the third month after stent implantation ]

    Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0

    = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction



Secondary Outcome Measures :
  1. overall survival （OS） [ Time Frame: From randomization until death （up to 24 months） ]
    overall survival

  2. technical success [ Time Frame: one week after stent implantation ]
    successful implantation of the stent across the stricture with appropriate positioning of the stent and full expansion

  3. complications and side effects [ Time Frame: From randomization until death （up to 24 months） ]
    Possible radiation related complications included neutropenia, decrease in IgA, IgG, and IgM, and leakage of radioactive seeds.Neutropenia was defined as a total white blood cell count b4000/mm3 in the plasma. The leakage of radioactive seeds was defined as the detection of non-target radioactive source verified by radiography

  4. tumor growth rate [ Time Frame: From randomization until death （up to 24 months） ]
    the size of tumor assessed by CT after stent implantation

  5. the time of emergency endoscopic treatment [ Time Frame: From randomization until death （up to 24 months） ]
    record the time of emergency endoscopic treatment for the recurrent severe dyspnea of patient


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age range: 18-75 years old, male or female who is not pregnant
  2. Comply with the diagnosis of malignant central airway stenosis, and undergo chest CT or bronchoscopy to confirm that the stenosis degree is above 50% and need to be implanted with airway metal stent; or the patient has obvious dyspnea due to airway stenosis, obstructive pneumonia
  3. Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up.
  4. Unable or refused surgery
  5. Unable or refused external radiation therapy
  6. Unable or refuse systemic tumor-related drugs therapy within 3 months

Exclusion Criteria:

  1. The distal end of the stenosis is unpredictable, and the stent treatment may not be satisfactory;
  2. Severe arrhythmia, acute myocardial ischemia, uncontrollable hypertensive crisis;
  3. Severe coagulopathy
  4. Severe organ dysfunction (except respiratory insufficiency)
  5. Allergic to anesthetics
  6. Airway fistula lesions
  7. The narrow lesion involves 2cm inside the glottis
  8. History of extrathoracic radiation therapy in the past 6 months
  9. Severe myelosuppression
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Chengshui Chen, doctor 86 13806889081 ext 8613806889081 wzchencs@163.com
Contact: Xiaoxiao Lin, doctor 8615068252060 ext 8615068252060 295357950@qq.com

Locations
Layout table for location information
China, Zhejiang
The first affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
Shanghai 10th People's Hospital
The Second Affiliated Hospital of Xiamen Medical College
Anhui Chest Hospital
China Meitan General Hospital
The Second Hospital of Hebei Medical University
West China Hospital
The Second Affiliated Hospital of Fujian Medical University
Wuhan Central Hospital
Wuhan No.1 Hospital
Hunan People's Hospital
First Affiliated Hospital of Chongqing Medical University
Yichang Central People's Hospital
Investigators
Layout table for investigator information
Study Chair: Chengshui Chen, doctor First Affiliated Hospital of Wenzhou Medical University
Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date May 9, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • stenosis grade [ Time Frame: the first month after stent implantation ]
    Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0 = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction
  • stenosis grade [ Time Frame: the third month after stent implantation ]
    Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0 = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • overall survival （OS） [ Time Frame: From randomization until death （up to 24 months） ]
    overall survival
  • technical success [ Time Frame: one week after stent implantation ]
    successful implantation of the stent across the stricture with appropriate positioning of the stent and full expansion
  • complications and side effects [ Time Frame: From randomization until death （up to 24 months） ]
    Possible radiation related complications included neutropenia, decrease in IgA, IgG, and IgM, and leakage of radioactive seeds.Neutropenia was defined as a total white blood cell count b4000/mm3 in the plasma. The leakage of radioactive seeds was defined as the detection of non-target radioactive source verified by radiography
  • tumor growth rate [ Time Frame: From randomization until death （up to 24 months） ]
    the size of tumor assessed by CT after stent implantation
  • the time of emergency endoscopic treatment [ Time Frame: From randomization until death （up to 24 months） ]
    record the time of emergency endoscopic treatment for the recurrent severe dyspnea of patient
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Metal Bare Stent With 125 Iodine （125I）Seeds for the Treatment of Malignant Central Airway Stenosis
Official Title  ICMJE The Efficacy and Safety of a Metal Bare Stent With 125I Seeds for the Treatment of Malignant Central Airway Compared to a Metal Bare Stent: A Multicentric Randomized Controlled Study.
Brief Summary Malignant central airway stenosis caused by primary or metastatic malignant tumor may lead to dyspnea even death of patients.With the rapid development of interventional pulmonology, bronchoscopic therapy has become the main treatment for malignant central airway stenosis. Metal stent implantation in airway can quickly relieve respiratory obstruction and improve quality of life.However, the tumor tissue can continue to grow into metal stent and obstruct airway again. This is the shortcoming of metal bare stents, which often need further treatment to keep airway open, including ablation, laser, cryotherapy, external radiotherapy or systemic anti-tumor drug therapy.Metal stent implantation combined with external radiotherapy can effectively reduce the incidence of airway restenosis.However, complications of external radiotherapy are high, including bone marrow suppression, radioactive pneumonia, radioactive esophagitis, myocardial injury and tracheoesophageal fistula, of which may cause serious consequences and even cause death of the patient.125I radioactive seeds have been one of the mature radioactive interventional therapy, which release X rays, and γ rays. Because of the short radioactive distance, 125I seeds can destruct tumor cells in tumor site and promote apoptosis and necrosis of tumor cells around the obstruction of the airway, meanwhile cause little damage to the surrounding normal tissues. Some studies showed that 125I seed implantation of lung tumor lesions achieved good short-term results.Therefore, the investigators hypothesize that 125I seeds fixed on the metal bare stent can not only improve the patient's breathing difficulties, but also play a role in killing tumor cells. At present, there have been reports of related clinical cases and monocentric control studies of malignant central airway stenosis treated with the implantation of metal stent with 125I seeds, but there is a lack of multicentric clinical studies with large samples.
Detailed Description It is an open, multicentric randomized controlled clinical trial conducted in China, and plan to recruiting 200 patients who suffer malignant central airway stenosis. To evaluate the efficacy and safety of metal stent with 125I seeds group and metal bare stent group in the treatment of malignant central airway stenosis, follow-up should be done within 1 week, 1 month, and 3 months after the first treatment, followed by every 3 months. The contents include review of bronchoscopy and chest CT, blood routine, immune indicators (IgA, immunoglobulin M（Ig M）, IgG), evaluation of general conditions. The patients of the first group need emission-computed tomography（ECT） imaging or positron emission tomography-computed tomography （PET-CT） examination within 1 month. If the patient has severe dyspnea, emergency bronchoscopy should be performed .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Airway Obstruction
Intervention  ICMJE Procedure: stent implantation
stent implantation
Study Arms  ICMJE
  • Experimental: A metal bare stent with 125I seeds
    125I seeds fixed on the metal bare stent, then stent implantation
    Intervention: Procedure: stent implantation
  • A metal bare stent
    A metal bare stent implantation
    Intervention: Procedure: stent implantation
Publications *
  • Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. Review.
  • Ong P, Grosu HB, Debiane L, Casal RF, Eapen GA, Jimenez CA, Noor L, Ost DE. Long-term quality-adjusted survival following therapeutic bronchoscopy for malignant central airway obstruction. Thorax. 2019 Feb;74(2):141-156. doi: 10.1136/thoraxjnl-2018-211521. Epub 2018 Sep 25.
  • Wood DE, Liu YH, Vallières E, Karmy-Jones R, Mulligan MS. Airway stenting for malignant and benign tracheobronchial stenosis. Ann Thorac Surg. 2003 Jul;76(1):167-72; discussion 173-4.
  • Saad CP, Murthy S, Krizmanich G, Mehta AC. Self-expandable metallic airway stents and flexible bronchoscopy: long-term outcomes analysis. Chest. 2003 Nov;124(5):1993-9.
  • Sabath BF, Ost DE. Update on airway stents. Curr Opin Pulm Med. 2018 Jul;24(4):343-349. doi: 10.1097/MCP.0000000000000486. Review.
  • Lemaire A, Burfeind WR, Toloza E, Balderson S, Petersen RP, Harpole DH Jr, D'Amico TA. Outcomes of tracheobronchial stents in patients with malignant airway disease. Ann Thorac Surg. 2005 Aug;80(2):434-7; discussion 437-8.
  • Rochet N, Hauswald H, Schmaus M, Hensley F, Huber P, Eberhardt R, Herth FJ, Debus J, Neuhof D. Safety and efficacy of thoracic external beam radiotherapy after airway stenting in malignant airway obstruction. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):e129-35. doi: 10.1016/j.ijrobp.2011.11.055.
  • Qu A, Wang H, Li J, Wang J, Liu J, Hou Y, Huang L, Zhao Y. Biological effects of (125)i seeds radiation on A549 lung cancer cells: G2/M arrest and enhanced cell death. Cancer Invest. 2014 Jul;32(6):209-17. doi: 10.3109/07357907.2014.905585. Epub 2014 Apr 18.
  • Wang Y, Lu J, Guo JH, Zhu GY, Zhu HD, Chen L, Wang C, Teng GJ. A Novel Tracheobronchial Stent Loaded with (125)I Seeds in Patients with Malignant Airway Obstruction Compared to a Conventional Stent: A Prospective Randomized Controlled Study. EBioMedicine. 2018 Jul;33:269-275. doi: 10.1016/j.ebiom.2018.06.006. Epub 2018 Jun 14.
  • Lu M, Pu D, Zhang W, Liao J, Zhang T, Yang G, Liu Z, Singh S, Gao F, Zhang F. Trans-bronchoscopy with implantation of (125)I radioactive seeds in patients with pulmonary atelectasis induced by lung cancer. Oncol Lett. 2015 Jul;10(1):216-222. Epub 2015 May 13.
  • Mallick I, Sharma SC, Behera D. Endobronchial brachytherapy for symptom palliation in non-small cell lung cancer--analysis of symptom response, endoscopic improvement and quality of life. Lung Cancer. 2007 Mar;55(3):313-8. Epub 2006 Dec 8.
  • Wang Y, Guo JH, Zhu GY, Zhu HD, Chen L, Lu J, Wang C, Teng GJ. A Novel Self-Expandable, Radioactive Airway Stent Loaded with (125)I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog. Cardiovasc Intervent Radiol. 2017 Jul;40(7):1086-1093. doi: 10.1007/s00270-017-1639-8. Epub 2017 Apr 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age range: 18-75 years old, male or female who is not pregnant
  2. Comply with the diagnosis of malignant central airway stenosis, and undergo chest CT or bronchoscopy to confirm that the stenosis degree is above 50% and need to be implanted with airway metal stent; or the patient has obvious dyspnea due to airway stenosis, obstructive pneumonia
  3. Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up.
  4. Unable or refused surgery
  5. Unable or refused external radiation therapy
  6. Unable or refuse systemic tumor-related drugs therapy within 3 months

Exclusion Criteria:

  1. The distal end of the stenosis is unpredictable, and the stent treatment may not be satisfactory;
  2. Severe arrhythmia, acute myocardial ischemia, uncontrollable hypertensive crisis;
  3. Severe coagulopathy
  4. Severe organ dysfunction (except respiratory insufficiency)
  5. Allergic to anesthetics
  6. Airway fistula lesions
  7. The narrow lesion involves 2cm inside the glottis
  8. History of extrathoracic radiation therapy in the past 6 months
  9. Severe myelosuppression
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chengshui Chen, doctor 86 13806889081 ext 8613806889081 wzchencs@163.com
Contact: Xiaoxiao Lin, doctor 8615068252060 ext 8615068252060 295357950@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03944408
Other Study ID Numbers  ICMJE wzchencs
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party First Affiliated Hospital of Wenzhou Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Wenzhou Medical University
Collaborators  ICMJE
  • Shanghai 10th People's Hospital
  • The Second Affiliated Hospital of Xiamen Medical College
  • Anhui Chest Hospital
  • China Meitan General Hospital
  • The Second Hospital of Hebei Medical University
  • West China Hospital
  • The Second Affiliated Hospital of Fujian Medical University
  • Wuhan Central Hospital
  • Wuhan No.1 Hospital
  • Hunan People's Hospital
  • First Affiliated Hospital of Chongqing Medical University
  • Yichang Central People's Hospital
Investigators  ICMJE
Study Chair: Chengshui Chen, doctor First Affiliated Hospital of Wenzhou Medical University
PRS Account First Affiliated Hospital of Wenzhou Medical University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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