Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

8 maj 2019 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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 .

Studietyp

Interventionell

Inskrivning (Förväntat)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: A metal bare stent with 125I seeds
125I seeds fixed on the metal bare stent, then stent implantation
Procedur: stent implantation
stent implantation
Övrig: A metal bare stent
A metal bare stent implantation
Procedur: stent implantation
stent implantation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
stenosis grade
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
overall survival （OS）
Tidsram: From randomization until death （up to 24 months）
overall survival
From randomization until death （up to 24 months）
technical success
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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）

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 maj 2019

Primärt slutförande (Förväntat)

1 juli 2021

Avslutad studie (Förväntat)

1 februari 2022

Studieregistreringsdatum

Först inskickad

5 maj 2019

Först inskickad som uppfyllde QC-kriterierna

8 maj 2019

Första postat (Faktisk)

9 maj 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 maj 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 maj 2019

Senast verifierad

1 maj 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • wzchencs

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Maligna luftvägsobstruktion

Kliniska prövningar på stent implantation

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Belarus

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera