Objective:Delayed gastric emptying (DGE) after pylorus-preservingpancreatoduodenectomy (PpPD) is a persistent and frustrating complication. Topreserve pylorus ring with denervation and devascularization may be a risk factorof DGE after pancreaticoduodenectomy. We conducted this study to confirm thehypothesis that pylorus-resecting pancreatoduodenectomy (PrPD) reduces theincidence of DGE compared to PpPD. Moreover, long-term outcomes of PrPDand the adverse effect of postsurgical DGE on long-term outcomes have not beenreported. Therefore, in addition, this study focused on long-term outcomes during24 months after surgery between PrPD versus PpPD.Methods: Between October 2005 and March 2009, at Wakayama MedicalUniversity Hospital (WMUH), 130 patients with pancreatic or periampullarylesions were randomized to preservation of the pylorus ring (PpPD) or to resectionof the pylorus ring (PrPD). In PpPD, the proximal duodenum was divided 3-4cmdistal to the pylorus ring. In PrPD, the stomach was divided just adjacent thepylorus ring and the nearly total stomach more than 95% was preserved. Shorttermand long-term outcomes were evaluated between PpPD and PrPD. Primaryendpoint is the incidence of DGE. DGE was defined according to a consensusdefinition and clinical grading about postoperative DGE proposed by theinternational study group of pancreatic surgery (ISGPS). This RCT was registeredat Clinical Trials.Gov NCT00639314.Results: Of 130 patients who were enrolled in this study, 64 patients wererandomized to PpPD and 66 to PrPD. The overall incidence of DGE in this RCTwas 10.8% (14 of 130 patients); the overall incidence of DGE was significantlylower in PrPD (4.5%) than PpPD (17.2%) (P =0 .0244). DGE was classified intothree categories proposed by the International Study Group of Pancreatic Surgery.The proposed clinical grading classified 11 cases of DGE in PpPD into grades A(n=6), B (n=5), and C (n=0), and one case in PrPD into each of the three grades.In long-term outcomes, weight loss > grade 2 (Common Terminology Criteriafor Adverse Events, Ver. 4.0) at 24 months after surgery improved significantlyin PrPD (16.2%) compared with PpPD (42.2%) (P = 0.011). Nutritional statusand late postoperative complications were similar between PpPD and PrPD. Theincidence of weight loss greater than Grade 2 at 24 months after surgery was63.6% in patients with DGE group and 25.3% in patients without DGE group (P= 0.010). Tmax (the time to peak 13CO2 content in 13C-acetate breath test) at24 months after surgery in patients with DGE was significantly delayed comparedwith those without DGE (27.9 ± 22.7min vs.16.5 ± 10.1min, P=0.023). Serumalbumin at 24 months after surgery was higher in patients without DGE than thosewith DGE (3.7±0.6 g/dl vs. 4.1±0.4 g/dl, P=0.013).Conclusion: This study clarified that PrPD can lead to a significant reduction inthe incidence of DGE compared with PpPD. Moreover, PrPD offers similar longtermoutcomes with PpPD. DGE may be associated with weight loss and poornutritional status in long-term outcomes.

Objective:Delayed gastric emptying (DGE) after pylorus-preserving pancreatoduodenectomy (PpPD) is a persistent and frustrating complication. To preserve pylorus ring with denervation and devascularization may be a risk factor of DGE after pancreaticoduodenectomy. We conducted this study to confirm the hypothesis that pylorus-resecting pancreatoduodenectomy (PrPD) reduces the incidence of DGE compared to PpPD. Moreover, long-term outcomes of PrPD and the adverse effect of postsurgical DGE on long-term outcomes have not been reported. Therefore, in addition, this study focused on long-term outcomes during 24 months after surgery between PrPD versus PpPD. Methods: Between October 2005 and March 2009, at Wakayama Medical University Hospital (WMUH), 130 patients with pancreatic or periampullary lesions were randomized to preservation of the pylorus ring (PpPD) or to resection of the pylorus ring (PrPD). In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring. In PrPD, the stomach was divided just adjacent the pylorus ring and the nearly total stomach more than 95% was preserved. Shortterm and long-term outcomes were evaluated between PpPD and PrPD. Primary endpoint is the incidence of DGE. DGE was defined according to a consensus definition and clinical grading about postoperative DGE proposed by the international study group of pancreatic surgery (ISGPS). This RCT was registered at Clinical Trials.Gov NCT00639314. Results: Of 130 patients who were enrolled in this study, 64 patients were randomized to PpPD and 66 to PrPD. The overall incidence of DGE in this RCT was 10.8% (14 of 130 patients); the overall incidence of DGE was significantly lower in PrPD (4.5%) than PpPD (17.2%) (P =0 .0244). DGE was classified into three categories proposed by the International Study Group of Pancreatic Surgery. The proposed clinical grading classified 11 cases of DGE in PpPD into grades A (n=6), B (n=5), and C (n=0), and one case in PrPD into each of the three grades. In long-term outcomes, weight loss > grade 2 (Common Terminology Criteria for Adverse Events, Ver. 4.0) at 24 months after surgery improved significantly in PrPD (16.2%) compared with PpPD (42.2%) (P = 0.011). Nutritional status and late postoperative complications were similar between PpPD and PrPD. The incidence of weight loss greater than Grade 2 at 24 months after surgery was 63.6% in patients with DGE group and 25.3% in patients without DGE group (P = 0.010). Tmax (the time to peak 13CO2 content in 13C-acetate breath test) at 24 months after surgery in patients with DGE was significantly delayed compared with those without DGE (27.9 ± 22.7min vs.16.5 ± 10.1min, P=0.023). Serum albumin at 24 months after surgery was higher in patients without DGE than those with DGE (3.7±0.6 g/dl vs. 4.1±0.4 g/dl, P=0.013). Conclusion: This study clarified that PrPD can lead to a significant reduction in the incidence of DGE compared with PpPD. Moreover, PrPD offers similar longterm outcomes with PpPD. DGE may be associated with weight loss and poor nutritional status in long-term outcomes.