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

8. maj 2019 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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 .

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Zhejiang
      • Wenzhou, Zhejiang, Kina, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A metal bare stent with 125I seeds
125I seeds fixed on the metal bare stent, then stent implantation
Procedure: stent implantation
stent implantation
Andet: A metal bare stent
A metal bare stent implantation
Procedure: stent implantation
stent implantation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
stenosis grade
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
overall survival （OS）
Tidsramme: From randomization until death （up to 24 months）
overall survival
From randomization until death （up to 24 months）
technical success
Tidsramme: one week after stent implantation
successful implantation of the stent across the stricture with appropriate positioning of the stent and full expansion
one week after stent implantation
complications and side effects
Tidsramme: 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）
tumor growth rate
Tidsramme: From randomization until death （up to 24 months）
the size of tumor assessed by CT after stent implantation
From randomization until death （up to 24 months）
the time of emergency endoscopic treatment
Tidsramme: From randomization until death （up to 24 months）
record the time of emergency endoscopic treatment for the recurrent severe dyspnea of patient
From randomization until death （up to 24 months）

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Samarbejdspartnere

The Second Hospital of Hebei Medical University
West China Hospital
Shanghai 10th People's Hospital
First Affiliated Hospital of Chongqing Medical University
Yichang Central People's Hospital
The Second Affiliated Hospital of Xiamen Medical College
Anhui Chest Hospital
China Meitan General Hospital
The Second Affiliated Hospital of Fujian Medical University
Wuhan Central Hospital
Wuhan No.1 Hospital
Hunan People's Hospital

Efterforskere

  • Studiestol: Chengshui Chen, doctor, First Affiliated Hospital of Wenzhou Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. maj 2019

Primær færdiggørelse (Forventet)

1. juli 2021

Studieafslutning (Forventet)

1. februar 2022

Datoer for studieregistrering

Først indsendt

5. maj 2019

Først indsendt, der opfyldte QC-kriterier

8. maj 2019

Først opslået (Faktiske)

9. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • wzchencs

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