Safety and efficacy of peripheral nutrition fluid (MG-TNA®) in patients undergoing surgery for hepatobiliary and pancreatic disease: Results of a phase 4 trial

Abstract

Backgrounds/aims: Essential nutritional support and nutrition therapy for patients with hepatobiliary and pancreatic diseases undergoing surgery is critical, as it may improve clinical outcome. How to implement rational fluid therapy and nutritional support after surgery and effectively protect organ function is crucial for postoperative recovery. The aim this study was to examine the safety and efficacy of peripheral nutrition fluid (MG-TNA®) in patients undergoing surgery for hepatobiliary and pancreatic disease.

Methods: All adult patients undergoing surgery for hepatobiliary and pancreatic disease received peripheral nutrition fluid (MG-TNA®) on the second postoperative day for 3 days. During administration of parenteral nutrition, patients were closely monitored for adverse effects (primary endpoint). Secondary endpoints included nutritional parameters such as serum prealbumin, transferrin, and creatine kinase (CK) levels.

Results: Thirty patients completed the study and were included in the full analysis set. There was no evidence of metabolic complications such as hyperglycemia, azotemia, hypertriglyceridemia, metabolic acidosis and hypokalemia. In addition, there were no adverse effects. There was a significant decrease in serum prealbumin and CK on the third postoperative day (p<0.0001). Although not statistically significant, serum transferrin levels tended to decrease (p=0.0519).

Conclusions: Administration of peripheral nutrition fluid (MG-TNA®) during postoperative period in patients undergoing surgery for hepatobiliary and pancreatic disease proved to be safe with improvement of the nutritional state of the patient.

Keywords: Efficacy; Fluid therapy; Nutritional support; Safety.

Fig. 1. Schematic diagram of study protocol. After screening prior to surgery, all patients who met the inclusion criteria received peripheral nutrition fluid (MG-TNA®) starting on the second postoperative day for 3 days. OP: Operation, POD: Postoperative day, EOS: End of study.

Fig. 2. Change from baseline to postoperative day (POD) 3 and POD 5 of (A) prealbumin, (B) transferrin and (C) creatine kinase. There was a significant decrease in serum prealbumin and CK on the third postoperative day (p<0.0001). Although not significant, serum transferrin levels tended to decrease (p=0.0519). ^†p>0.05, ^‡p<0.05.