Intraoperative Endoluminal Pyloromyotomy Versus Stretching of the Pylorus for the Reduction of Delayed Gastric Emptying After Pylorus-Preserving Partial Pancreatoduodenectomy: A Blinded Randomized Controlled Trial (PORRIDGE Study; DRKS00013503).

Abstract

Pylorus-preserving partial pancreatoduodenectomy (ppPD) is a treatment for tumors of the pancreatic head. Delayed gastric emptying (DGE) is one of the most common complications following ppPD. In a retrospective analysis, intraoperative endoluminal pyloromyotomy (PM) was shown to be associated with a reduction in DGE rates. The aim of this randomized controlled trial was to investigate the effect of intraoperative endoluminal PM on DGE after ppPD. Patients undergoing ppPD were randomized intraoperatively to receive either PM or atraumatic stretching of the pylorus prior to creation of the duodenojejunostomy. The primary endpoint was the rate of DGE within 30 days after surgery. Sixty-four patients were randomly assigned to the PM group and 64 patients were assigned to the control group. There were no differences between the two groups regarding baseline characteristics. The DGE rate was 59.4% (76/126). In two patients (1.6%) DGE was not assessable. The most common DGE grade was A (51/126, 40.5%), followed by B (20/126, 15.9%) and C (5/126, 4.0%). The rate of DGE was 62.5% in the PM group versus 56.3% in the control group (odds ratio 1.41, 95% confidence interval 0.69-2.90; p = 0.34). The complication rate did not differ between both groups (p = 0.79) and there were no differences in quality of life on postoperative day 30. Intraoperative endoluminal PM did not reduce the rate or severity of DGE after ppPD compared with atraumatic stretching of the pylorus.