Randomized trial of two types of gastrojejunostomy after pancreatoduodenectomy and risk of delayed gastric emptying (PAUDA trial).

BACKGROUND: Delayed gastric emptying (DGE) is the most important cause of an extended hospital stay after pancreatoduodenectomy. Reports suggest that a Roux-en-Y gastroenteric anastomosis may have lower incidence of DGE than a Billroth II reconstruction. The primary aim of this RCT was to compare Billroth II (single loop) and Roux-en-Y (double loop) after pancreatoduodenectomy to determine whether Roux-en-Y reconstruction is associated with a lower incidence of DGE. Secondary endpoints were postoperative complications.

METHODS: This was a randomized unblinded single-centre trial without masked evaluation of the main outcome. Patients undergoing pancreatoduodenectomy between 2013 and 2015 were randomized to undergo one of two types of gastroenteric anastomosis for reconstruction.

RESULTS: A total of 80 patients were randomized, 40 in each group. The incidence of DGE was the same in patients undergoing Billroth II or Roux-en-Y gastroenteric anastomosis (both 18 of 40 patients; P = 1·000). The grade of DGE was also similar in the Billroth II and Roux-en-Y groups (grade A, both 10 of 40; grade B, 5 of 40 versus 6 of 40; grade C, 3 of 40 versus 2 of 40; P = 0·962). The mortality rate was 3 per cent, with no significant difference between the two groups. There were no differences in the overall rate of postoperative morbidity, relaparotomy rate or duration of hospital stay.

CONCLUSION: The incidence and severity of DGE does not differ between single- or double-loop gastroenteric anastomosis performed after pancreatoduodenectomy. Registration number: NCT00915863 (https://www.clinicaltrials.gov).