NCT03944408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

May 5, 2019

Last Update Submit

May 8, 2019

Conditions

Malignant Airway Obstruction

Outcome Measures

Primary Outcomes (2)

  • stenosis grade

    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

    the first month after stent implantation

  • stenosis grade

    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

    the third month after stent implantation

Secondary Outcomes (5)

  • overall survival （OS）

    From randomization until death （up to 24 months）

  • technical success

    one week after stent implantation

  • complications and side effects

    From randomization until death （up to 24 months）

  • tumor growth rate

    From randomization until death （up to 24 months）

  • the time of emergency endoscopic treatment

    From randomization until death （up to 24 months）

Study Arms (2)

A metal bare stent with 125I seeds

EXPERIMENTAL

125I seeds fixed on the metal bare stent, then stent implantation

Procedure: stent implantation

A metal bare stent

OTHER

A metal bare stent implantation

Procedure: stent implantation

Interventions

stent implantationPROCEDURE

stent implantation

A metal bare stentA metal bare stent with 125I seeds

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range: 18-75 years old, male or female who is not pregnant
  • 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
  • Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up.
  • Unable or refused surgery
  • Unable or refused external radiation therapy
  • Unable or refuse systemic tumor-related drugs therapy within 3 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of wenzhou medical university

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (12)

  • 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. doi: 10.1164/rccm.200210-1181SO.

    PMID: 15187010RESULT

  • 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.

    PMID: 30254139RESULT

  • Wood DE, Liu YH, Vallieres 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. doi: 10.1016/s0003-4975(03)00033-x.

    PMID: 12842534RESULT

  • 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. doi: 10.1378/chest.124.5.1993.

    PMID: 14605078RESULT

  • Sabath BF, Ost DE. Update on airway stents. Curr Opin Pulm Med. 2018 Jul;24(4):343-349. doi: 10.1097/MCP.0000000000000486.

    PMID: 29538079RESULT

  • 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. doi: 10.1016/j.athoracsur.2005.02.071.

    PMID: 16039180RESULT

  • 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.

    PMID: 22516383RESULT

  • 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.

    PMID: 24745612RESULT

  • Wang Y, Lu J, Guo JH, Zhu GY, Zhu HD, Chen L, Wang C, Teng GJ. A Novel Tracheobronchial Stent Loaded with 125I 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.

    PMID: 29909977RESULT

  • 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 125I radioactive seeds in patients with pulmonary atelectasis induced by lung cancer. Oncol Lett. 2015 Jul;10(1):216-222. doi: 10.3892/ol.2015.3204. Epub 2015 May 13.

    PMID: 26171002RESULT

  • 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. doi: 10.1016/j.lungcan.2006.10.018. Epub 2006 Dec 8.

    PMID: 17157949RESULT

  • 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 125I 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.

    PMID: 28389860RESULT

Study Officials

  • Chengshui Chen, doctor

    First Affiliated Hospital of Wenzhou Medical University

    STUDY CHAIR

Central Study Contacts

Chengshui Chen, doctor

CONTACT

86 13806889081wzchencs@163.com

Xiaoxiao Lin, doctor

CONTACT

8615068252060295357950@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2019

First Posted

May 9, 2019

Study Start

May 1, 2019

Primary Completion

July 1, 2021

Study Completion

February 1, 2022

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)