A Trail of a Novel Tracheal Radioactive Stent for the Malignant Airway Obstruction

NCT02565927 | Unknown Phase 2

• 1 other identifier: 2015ZDSYLL032.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the safety and effectiveness of an radioactive airway stent loaded with 125I seeds compared to a conventional airway stent in patients with malignant airway obstruction caused by both primary and metastatic malignant tumors.

Conditions

Malignant Airway Obstruction

Keywords

Trachea; Stent; Intraluminal brachytherapy

Outcome Measures

Primary Outcomes (1)

• diameter stenosis

  reference tracheal diameter minus minimum diameter at stenosis site / reference tracheal diameter×100

  Participants will be followed till die or lost to follow-up,an expected average of a year.

Secondary Outcomes (1)

• Over survival

  Participants will be followed till die or lost to follow-up,an expected average of a year.

Other Outcomes (4)

• Success rate

  Participants will be followed till die or lost to follow-up,an expected average of a year.

• Number of participants with abnormal laboratory values that are telated to treatment

  Participants will be followed till die or lost to follow-up,an expected average of a year.

• Number of participants with adverse events that are telated to treatment

  Participants will be followed till die or lost to follow-up,an expected average of a year.

Study Arms (2)

Radioactive stent

EXPERIMENTAL

Patients diagnosed as MAO treated with radioactive airway stent loaded with Iodine-125 seeds

Device: Traditional airway stent; Drug: Iodine-125 seeds

Traditional airway stent

ACTIVE COMPARATOR

Patients diagnosed as MAO treated with traditional airway stent

Device: Traditional airway stent

Interventions

Traditional airway stent DEVICE

process airway stenting

Also known as: Tracheal stent(Nanjing MicroInvasive Medical Inc.)

Radioactive stent; Traditional airway stent

Iodine-125 seeds DRUG

process intraluminal brachytherapy

Also known as: Radioactive seeds(Chinese Atomic Energy Science Institution)

Radioactive stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 80 years
• MAO caused by any adenocarcinoma with histologically or cytologically confirmation by biopsy or previous surgical procedures
• symptoms such as dyspnea related to biliary obstruction
• unresectability or refusal to be surgically treated
• willing and able to comply with the study procedures and provide written informed consent to participate

You may not qualify if:

• patients with suspected benign airway obstruction
• airway obstruction that could not be dilated enough to pass the delivery system
• perforation of any ducts within the tracheal tree
• presence of metallic tracheal stent or airway surgery
• acute or chronic inflammation in the airway
• uncooperative or could not provide authorization and signature.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Gao-jun Teng, Ph.D,MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Wang, Ph.D

CONTACT

medicalusing@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Interventional Radiology & Vascular Surgery

Study Record Dates

• First Submitted: September 20, 2015
• First Posted: October 1, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

CN (1)