Background: The optimal approach to the investigation of mediastinal disease in patients with apparently operable non-small cell carcinoma of the lung is controversial.
Methods: We conducted a randomized, controlled trial in thoracic surgery services at mainly academic tertiary and secondary care general hospitals. We recruited 685 patients with apparently operable, suspected or proven, non-small cell carcinoma of the lung who underwent either mediastinoscopy or computed tomography. Depending on the apparent presence or absence of mediastinal nodes of greater than 1 cm, patients undergoing computed tomography either underwent mediastinoscopy or went directly to thoracotomy. The primary outcome was thoracotomy without cure, defined as resection with recurrence. Secondary outcomes included thoracotomies undertaken in patients with benign disease and costs of the two strategies.
Results: The relative risk of thoracotomy without cure in patients in the computed tomography group was 0.95 (95% confidence interval, 0.75 to 1.19). The relative risk of thoracotomy without cure or thoracotomy in patients with benign disease was 0.88 (95% confidence interval, 0.71 to 1.10). The mediastinoscopy strategy cost $708 more per patient (95% confidence interval, -$723 to $2,140).
Conclusions: The computed tomography strategy is likely to produce the same number of or fewer unnecessary thoracotomies in comparison with doing mediastinoscopy on all patients, and is also likely to be as or less expensive.