Early Nasojejunal Nutrition Versus Early Oral Feeding in Patients After Pancreaticoduodenectomy: A Randomized Controlled Trial
What this study found
Clinically relevant DGE: ENN 17.5%, EOF 10.0%, saline 32.5% (p=0.038); saline higher than EOF (p=0.014). Overall morbidity: ENN 30.0%, EOF 22.5%, saline 52.5% (p=0.041 ENN vs saline; p=0.006 EOF vs saline). No significant differences in other surgical complications or hospital stay; no mortality. Conclusion: Nutritional support method did not relate to DGE after PPPD overall; EOF is feasible and safe after PPPD, and additional ENN should not be routinely administered to patients after PPPD.
- Study & population
- Prospective, single-center, three-arm randomized controlled trial; 120 adults (>18 years) undergoing pylorus-preserving pancreaticoduodenectomy (PPPD) for periampullary neoplasms; ASA score <4; Exclusions: refusal, prior GI surgery, other Whipple procedures, unresectable disease; 40 participants per arm (ENN, EOF, saline).
- Intervention
- ENN: Enteral nutrition via nasojejunal tube started on postoperative day 2 at 30 mL/h with an initial 250 mL, increasing to full intake within 72 hours; total caloric intake targeted at 25–30 kcal/kg/day and protein 1.2–1.5 g/kg/day; parenteral nutrition from POD1 until full diet achieved; NJT removed on POD8; NGT…
- Key limitation
- Single-center, small sample size; open-label, not blinded; not randomized by nutritional state; potential type II error; limited generalizability.
Original abstract
Objective The aim of this study was to test the hypothesis that early oral feeding (EOF) is superior to early nasojejunal nutrition (ENN) after pylorus-preserving pancreaticoduodenectomy (PPPD) in terms of delayed gastric emptying (DGE). Background DGE is a common complication after PPPD. Although EOF after PPPD is recommended by several international guidelines, there is no randomized trial to support this recommendation. Methods From September 2016 to December 2017, a total of 120 patients undergoing PPPD were randomized into the ENN, EOF, or saline groups at a 1:1:1 ratio (40 patients in each group). The primary endpoint was the rate of clinically relevant DGE. Secondary endpoints included overall morbidity, postoperative pancreatic fistula, post-pancreatectomy hemorrhage, abdominal infection, length of hospital stay, reoperation rate, and in-hospital mortality. Results The baseline characteristics and operative parameters were comparable between the groups. The incidence of clinically relevant DGE varied significantly among the three groups (ENN, 17.5%; EOF, 10.0%; saline, 32.5%; p =0.038). The saline group had a higher clinically relevant DGE rate than the EOF group (p = 0.014). The saline group also had greater overall morbidities than the ENN and EOF groups (p = 0.041 and p = 0.006, respectively). There were no significant differences in other surgical complication rates or postoperative hospital stay. No mortality was observed in any of the groups. Conclusions Nutritional support methods were not related to DGE after PPPD. EOF was feasible and safe after PPPD, and additional ENN should not be routinely administered to patients after PPPD. Clinical Trial Registration ClinicalTrials.gov, identifier NCT03150615.