International journal of surgery (London, England) · 2026
Early versus late supplemental parenteral nutrition in gastrointestinal cancer patients undergoing major abdominal surgery: 5-year outcomes from a randomized clinical trial.
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Gao Xuejin, Zhang Yupeng, Xiao Yaqin, Gao Tingting, Jin Gang, Wang Kunhua, Zhou Yanbing, Chi Qiang, Yang Hua, Li Mengbin, Yu Jianchun, Qin Huanlong, Tang Yun, Wu Xiaoting, Li Guoli, Zhang Li, Wang Xinying
Аннотация
BACKGROUND: The long-term effects of supplemental parenteral nutrition (SPN) on survival and recurrence in gastrointestinal (GI) cancer patients undergoing major abdominal surgery remain unclear. This study reports the 5-year overall survival (OS) results from the PNASIT randomized clinical trial (RCT), which compared early SPN [initiated on postoperative day (POD) 3] versus late SPN (initiated on POD 8) in patients with GI undergoing major abdominal surgery.
METHODS: This multicenter, open-label, RCT was conducted at 11 centers in China. From 1 April 2017 to 31 December 2018, a total of 217 eligible patients with nutritional risk (Nutritional Risk Screening 2002) score ≥3) who were undergoing elective major abdominal surgery for GI cancer were enrolled. Patients were randomized into two groups: the early SPN group (E-SPN; n = 107) and the late SPN group (L-SPN; n = 110). The primary endpoint was 5-year OS, analyzed using Kaplan-Meier methods and Cox proportional hazards models on an intention-to-treat basis.
RESULTS: Among the 217 analyzed patients [mean (SD) age, 60.4 (12.2) years; 60.4% male; all of Asian ethnicity], the 5-year OS rate was 70.1% (75/107) in the E-SPN group and 66.4% (73/110) in the L-SPN group [hazard ratio (HR), 0.857; 95% confidence interval (CI), 0.535-1.374; log-rank P = 0.520]. No significant differences were observed in 5-year disease-free survival rates, recurrence rates, or recurrence patterns between the two groups (all P > 0.05). HRQoL, as measured by the 36-Item Short Form Health Survey scale, was significantly higher in the E-SPN group compared with the L-SPN group during the first 6 postoperative months (P < 0.001). However, no significant differences were observed at 1, 3, or 5 years after surgery.
CONCLUSION: In GI cancer patients undergoing major abdominal surgery, early SPN showed no significant difference in 5-year OS compared with late SPN. The findings do not support the use of early SPN to improve long-term survival in this patient population.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03115957.
METHODS: This multicenter, open-label, RCT was conducted at 11 centers in China. From 1 April 2017 to 31 December 2018, a total of 217 eligible patients with nutritional risk (Nutritional Risk Screening 2002) score ≥3) who were undergoing elective major abdominal surgery for GI cancer were enrolled. Patients were randomized into two groups: the early SPN group (E-SPN; n = 107) and the late SPN group (L-SPN; n = 110). The primary endpoint was 5-year OS, analyzed using Kaplan-Meier methods and Cox proportional hazards models on an intention-to-treat basis.
RESULTS: Among the 217 analyzed patients [mean (SD) age, 60.4 (12.2) years; 60.4% male; all of Asian ethnicity], the 5-year OS rate was 70.1% (75/107) in the E-SPN group and 66.4% (73/110) in the L-SPN group [hazard ratio (HR), 0.857; 95% confidence interval (CI), 0.535-1.374; log-rank P = 0.520]. No significant differences were observed in 5-year disease-free survival rates, recurrence rates, or recurrence patterns between the two groups (all P > 0.05). HRQoL, as measured by the 36-Item Short Form Health Survey scale, was significantly higher in the E-SPN group compared with the L-SPN group during the first 6 postoperative months (P < 0.001). However, no significant differences were observed at 1, 3, or 5 years after surgery.
CONCLUSION: In GI cancer patients undergoing major abdominal surgery, early SPN showed no significant difference in 5-year OS compared with late SPN. The findings do not support the use of early SPN to improve long-term survival in this patient population.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03115957.