Pylorus Resection Does Not Reduce Delayed Gastric Emptying After Partial Pancreatoduodenectomy: A Blinded Randomized Controlled Trial (PROPP Study, DRKS00004191).

Thilo Hackert,Christoph W Michalski,Markus W Büchler,Lutz Schneider,Alexis Ulrich,Markus K Diener,Oliver Strobel,Pascal Probst,Colette Doerr-Harim,Jens Werner,Phillip Knebel,Ulla Klaiber,Thomas Bruckner

doi:10.1097/sla.0000000000002480

Abstract

The aim of this study was to investigate the effect of pylorus resection on postoperative delayed gastric emptying (DGE) after partial pancreatoduodenectomy (PD). PD is the standard treatment for tumors of the pancreatic head. Preservation of the pylorus has been widely accepted as standard procedure. DGE is a common complication causing impaired oral intake, prolonged hospital stay, and postponed further treatment. Recently, pylorus resection has been shown to reduce DGE. Patients undergoing PD for any indication at the University of Heidelberg were randomized to either PD with pylorus preservation (PP) or PD with pylorus resection and complete stomach preservation (PR). The primary endpoint was DGE within 30 days according to the International Study Group of Pancreatic Surgery definition. Ninety-five patients were randomized to PP and 93 patients to PR. There were no baseline imbalances between the groups. Overall, 53 of 188 patients (28.2%) developed a DGE (grade: A 15.5%; B 8.8%; C 3.3%). In the PP group 24 of 95 patients (25.3%) and in the PR group 29 of 93 patients (31.2%) developed DGE (odds ratio 1.534, 95% confidence interval 0.788 to 2.987; P = 0.208). Higher BMI, indigestion, and intraabdominal major complications were significant risk factors for DGE. In this randomized controlled trial, pylorus resection during PD did not reduce the incidence or severity of DGE. The development of DGE seems to be multifactorial rather than attributable to pyloric dysfunction alone. Pylorus preservation should therefore remain the standard of care in PD. German Clinical Trials Register DRKS00004191.

Highlights

The PROPP study was a single-center, randomized, controlled, patient- and observer-blinded trial (RCT) with 2 parallel groups and a statistical superiority hypothesis
In accordance with the International Study Group of Pancreatic Surgery (ISGPS) definition, delayed gastric emptying (DGE) was assessed as grade A if the nasogastric tube (NGT) was inserted during the first postoperative week but the patient returned to a solid oral diet before postoperative days (POD) 14
With 10 patients excluded from analysis (Fig. 1), the ITT population consisted of 188 patients (95 pylorus preservation (PP) and 93 PR)

Summary

Objectives

The aim of this study was to investigate the effect of pylorus resection on postoperative delayed gastric emptying (DGE) after partial pancreatoduodenectomy (PD). The primary endpoint was DGE within 30 days according to the International Study Group of Pancreatic Surgery definition. In accordance with the ISGPS definition, DGE was assessed as grade A if the NGT was inserted during the first postoperative week but the patient returned to a solid oral diet before POD 14. For DGE grade B, the NGTwas in place (still inserted or reinserted) during postoperative week 2 but return to solid diet was achieved before POD 21. Patients assessed as suffering from DGE grade C needed a NGT during the third week after operation. Gastric distension, vomiting, NGT insertion and removal dates, start of solid food intake, medication with metoclopramide, erythromycin, and strong oral laxatives, and diagnostic and interventional measures because of DGE were assessed

Methods

Results

Conclusion