Title ThoHSpEkt Study Design Pilot Study concerning the technical operative methods and a phase II study concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a new indication) Location Kantonsspital St.Gallen Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules with the help of free-hand SPECT. Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is not possible a switch to minithoracotomy is performed. Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided surgery Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal) Rational for patient number 10 patients for each group are enough to prove the feasibility, to manage difficulties and to record complications Duration approximately 24 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
11
Application directly into a pulmonary nodule
CT guided puncture is a standard procedure in radiology. In this study it is used to mark pulmonary nodules for the following thoracoscopic surgery, done with a handheld-SPECT device.
Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules.
Cantonal Hospital St.Gallen
Sankt Gallen, Switzerland
Successful thoracoscopic ectomies
Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications)
Time frame: 1 week
CT labelling
Success rate of CT labelling
Time frame: 1 day
CT Labelling complications
complication rate attributable to CT labelling
Time frame: 1 day
Successful labeling using electro-magnetically navigated bronchoscopy
Rate of successful labeling using electro-magnetically navigated bronchoscopy
Time frame: 1 day
Complications after labeling using electro-magnetically navigated bronchoscopy
Complication rate after labeling using electro-magnetically navigated bronchoscopy
Time frame: 1 day
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