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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Novel Tracheal Radioactive Stent Loaded With 125I Seeds for the Malignant Airway Obstruction Versus a Conventional Stent: A Prospective Randomized Controlled Trial

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.

Detailed Summary: Malignant tumors of the lung, esophagus, thyroid, or other mediastinal structures often involve the trachea by direct tumor growth compression and (or) invasion. In addition, extrathoracic cancers metastasize to these lymph nodes as well. However, surgical resection and airway reconstruction are the gold-standard treatment for MAO, many patients with airway involvement are poor surgical candidates based on physiologic or oncologic criteria.There are three main types of malignant airway obstruction: endobronchial obstruction, extrinsic compression, and a mixed pattern. For endobronchial obstruction, ablative techniques that destroy tissue are indicated, including lasers, electrocautery, argon plasma coagulation (APC), photodynamic therapy, microdebriders, and cryotherapy, but primary tracheal cancers are less common than other types of lung cancer. If the obstruction is exclusively or mainly due to compression from outside the airway wall, the only option consists of placement of a stent or endoprosthesis. However, follow-up data has demonstrated that postoperative restenosis of stenting occurs in 5-45% of cases as a result of neoplastic infiltration through the mesh into the lumen or tumor overgrowth above and below the mesh stents. Encouraged by the success of 125I esophageal and biliary stent in esophageal carcinoma , a tracheal stent loaded with 125I radioactive seeds was developed in investigators'institute. After successful in vitro and in vivo evaluations of the delivery system, investigator will prospectively compare responses to treatment with this irradiation tracheal stent versus the conventional self-expandable stent in patients with MAO.
Sponsor: Zhongda Hospital

Current Primary Outcome: diameter stenosis [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Over survival [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]

Time from stenting to the day when the patients died or lost to the follow-up.


Original Secondary Outcome: Same as current

Information By: Zhongda Hospital

Dates:
Date Received: September 20, 2015
Date Started: May 2015
Date Completion: September 2016
Last Updated: September 29, 2015
Last Verified: September 2015