Intraoperative application of inactivated Pseudomonas aeruginosa in patients undergoing lateral neck dissection for metastatic thyroid cancer: A randomized, parallel group, placebo-controlled trial.

ABSTRACT

BACKGROUND: We hypothesize that the intraoperative, prophylactic application of Pseudomonas aeruginosa can decrease postoperative chylous fistula and enhance recovery after surgery in patients with thyroid cancer undergoing lateral neck lymph node dissection. METHOD: In this single-center trial, we assigned randomly 200 patients with thyroid cancer who had proven lateral lymph node metastasis to groups receiving either 2 mL Pseudomonas aeruginosa spray (Pseudomonas aeruginosa group) or 2 mL saline spray (control group) in the lateral cervical surgical field. The primary end points were the rate of chylous fistula, mean difference in the duration and volume of drainage fluid, days of postoperative hospital stay, and overall cost. The secondary end points included the red blood cell count and triglyceride level in the drainage, the white blood cell count in the blood, fever, local pain, development of a pleural effusion, and tumor recurrence. RESULTS: Patients treated with Pseudomonas aeruginosa had a decrease in macroscopic chylous fistula compared with controls (0 vs 6%, P = .025). There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05). No severe side effects of the Pseudomonas aeruginosa spray with respect to fever, pain, or pleural effusion were observed. Pseudomonas aeruginosa spraying did not affect postoperative recurrence of the thyroid cancer. CONCLUSION: Intraoperative spraying of inactivated Pseudomonas aeruginosa in the lateral neck compartment can decrease the development of chylous fistula and enhance postoperative recovery.