A Metal Bare Stent With 125 Iodine （125I）Seeds for the Treatment of Malignant Central Airway Stenosis
8 mei 2019 bijgewerkt door: First Affiliated Hospital of Wenzhou Medical University
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.
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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 .
Studietype
Ingrijpend
Inschrijving (Verwacht)
200
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: A metal bare stent with 125I seeds
125I seeds fixed on the metal bare stent, then stent implantation
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stent implantation
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Ander: A metal bare stent
A metal bare stent implantation
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stent implantation
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
stenosis grade
Tijdsspanne: 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 |
the first month after stent implantation
|
|
stenosis grade
Tijdsspanne: 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 |
the third month after stent implantation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
overall survival （OS）
Tijdsspanne: From randomization until death （up to 24 months）
|
overall survival
|
From randomization until death （up to 24 months）
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technical success
Tijdsspanne: one week after stent implantation
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successful implantation of the stent across the stricture with appropriate positioning of the stent and full expansion
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one week after stent implantation
|
|
complications and side effects
Tijdsspanne: 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
|
From randomization until death （up to 24 months）
|
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tumor growth rate
Tijdsspanne: From randomization until death （up to 24 months）
|
the size of tumor assessed by CT after stent implantation
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From randomization until death （up to 24 months）
|
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the time of emergency endoscopic treatment
Tijdsspanne: From randomization until death （up to 24 months）
|
record the time of emergency endoscopic treatment for the recurrent severe dyspnea of patient
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From randomization until death （up to 24 months）
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie stoel: Chengshui Chen, doctor, First Affiliated Hospital of Wenzhou Medical University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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, 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.
- 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.
- Sabath BF, Ost DE. Update on airway stents. Curr Opin Pulm Med. 2018 Jul;24(4):343-349. doi: 10.1097/MCP.0000000000000486.
- 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.
- 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 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 mei 2019
Primaire voltooiing (Verwacht)
1 juli 2021
Studie voltooiing (Verwacht)
1 februari 2022
Studieregistratiedata
Eerst ingediend
5 mei 2019
Eerst ingediend dat voldeed aan de QC-criteria
8 mei 2019
Eerst geplaatst (Werkelijk)
9 mei 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 mei 2019
Laatste update ingediend die voldeed aan QC-criteria
8 mei 2019
Laatst geverifieerd
1 mei 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- wzchencs
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .