Body surface gastric mapping to determine gastric motility patterns associated with delayed gastric emptying after pancreaticoduodenectomy. Gastric Electric Mapping after Pancreatoduodenectomy study protocol

INTRODUCTION: Delayed gastric emptying (DGE) is frequent after pancreaticoduodenectomy (PD). Although often associated with postoperative pancreatic fistula, the precise pathogenesis in patients with no underlying complications remains unclear. There is evidence to suggest that, after surgery, aberrant electrical pathways are formed in the stomach which could contribute to the development of DGE. Gastric Alimetry is a novel technology which measures the electrical activity of the stomach non-invasively using an array of electrodes applied to the skin of the abdomen. This technique, termed body surface gastric mapping (BSGM), has been validated in normal controls and in patients with functional dyspepsia syndromes. This study will investigate the efficacy and feasibility of using BSGM to assess gastric motility in patients who undergo PD. METHODS AND ANALYSIS: This prospective cohort study will be conducted at a single large volume hepatobiliary unit in the UK. 50 patients who are planned to undergo PD will be included. BSGM measurement will be performed at four timepoints viz: preoperatively, day 4 postoperatively, at discharge and 6 months postoperatively. Key parameters of BSGM measurement, including wave amplitude, frequency and directional vector, will be measured at each timepoint and compared between different patient subgroups. Symptoms will be self-reported by patients during the recording using an iPad application designed for this purpose. Quality of life and patient experience will be assessed using standardised questionnaires at the end of the follow-up period. ETHICS AND DISSEMINATION: The protocol has been approved by the research ethics committees of Newcastle University and the Health Research Authority (HRA) of the UK (ethical approval IRAS ID 305302). Findings will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: This study will automatically be registered with the ISRCTN registry by the HRA as part of the ethics approval process.