Hideo Saka1, Masahide Oki2, Akiko Kada3, Akiko M Saito3. 1. Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan saka@med.nagoya-u.ac.jp. 2. Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan. 3. Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Abstract
BACKGROUND: An open-label, single-arm study was conducted to assess the safety of a cryosurgery unit named CRYO2 for debulking at the site of obstruction or stenosis. PATIENTS AND METHODS: In order to treat central airway tumor-related stenosis, debulking at the stenotic site of the airway was performed using CRYO2 under general or local anesthesia. The primary endpoint was the incidence of moderate to massive hemorrhage. RESULTS: Incidence of moderate to massive hemorrhage during surgery was 3.8% (1/26) (95% confidence interval(CI)=0.1-19.6%). Technical success was 96.2% (25/26), with a 95% confidence interval of 80.4-99.9%. CONCLUSION: CRYO2 for debulking at the site of obstruction or stenosis can be performed safely. Copyright
BACKGROUND: An open-label, single-arm study was conducted to assess the safety of a cryosurgery unit named CRYO2 for debulking at the site of obstruction or stenosis. PATIENTS AND METHODS: In order to treat central airway tumor-related stenosis, debulking at the stenotic site of the airway was performed using CRYO2 under general or local anesthesia. The primary endpoint was the incidence of moderate to massive hemorrhage. RESULTS: Incidence of moderate to massive hemorrhage during surgery was 3.8% (1/26) (95% confidence interval(CI)=0.1-19.6%). Technical success was 96.2% (25/26), with a 95% confidence interval of 80.4-99.9%. CONCLUSION:CRYO2 for debulking at the site of obstruction or stenosis can be performed safely. Copyright
Authors: Christian Schumann; Martin Hetzel; Alexander J Babiak; Jürgen Hetzel; Tobias Merk; Thomas Wibmer; Philipp M Lepper; Stefan Krüger Journal: J Thorac Cardiovasc Surg Date: 2009-08-27 Impact factor: 5.209