Study objective: To investigate the safety, efficacy, and tolerance of the covered Wallstent for the palliative treatment of inoperable tracheobronchial cancer. Design: An 8-month prospective study employing either a rigid bronschoscope or a flexible delivery system for prosthesis insertion. Setting: Multicentric setting involving four teaching hospitals in Switzerland and Germany. Patients: Forty patients (29 men, 11 women), average age of 62 years, presenting with an inoperable tracheobronchial cancer. Interventions: After partial airway recanalization with an Nd-YAG laser, the covered Wallstent was inserted 23 times using a rigid bronchoscope (Rigidstep device), and 27 times using a flexible delivery system (Telestep device) under fluoroscopic and endoscopic visualization. Results: Clinical and endoscopic examination at 1, 30, and 90 days showed improvement in the bronchial lumen and in the dyspnea index. No serious complication (death, perforation, hemorrhage, inability to remove an improperly placed prosthesis) was observed during surgery. Late complications included migration (12%), inflammatory granulations or tumor regrowth at the tip of the prosthesis (36%), and symptomatic retention of secretion (38%). Conclusions: Compared with other tracheobronchial prostheses, notably the Dumon stent, the covered Wallstent presents the following advantages: insertion with visual guidance, treatment of extrinsic compressions and esophagobronchial fistulas, and little chance of migration when the prosthesis diameter is chosen correctly. The following disadvantages can be noted: high price; both repositioning and extraction of the released stent are more difficult, though certainly possible; and risk of granulations at the tips of the prosthesis and retention of secretions. Suggestions are made for potential improvements to the stent and insertion system that may result in a significant decrease in early and late complications.
