Abstract
BackgroundPylorus-preserving pancreaticoduodenectomy (ppPD) is a standard surgical procedure for the treatment of resectable neoplasms of the periampullary region. One of the most common postoperative complications after ppPD is delayed gastric emptying (DGE) which reduces quality of life, prevents a timely return to a solid oral diet and prolongs the length of hospital stay. In a retrospective analysis, intraoperative endoluminal pyloromyotomy was associated with a reduced rate of DGE. The aim of this study is to investigate the effect of intraoperative endoluminal pyloromyotomy on postoperative DGE after ppPD in a randomised and controlled setting.MethodsThis randomised trial features parallel group design with a 1:1 allocation ratio and a superiority hypothesis. Patients with a minimum age of 18 years and an indication for ppPD are eligible to participate in this study and will be randomised intraoperatively to receive either endoluminal pyloromyotomy or atraumatic stretching of the pylorus. The sample size calculation (n=64 per study arm) is based on retrospective data. The primary endpoint is the rate of DGE within 30 days. Secondary endpoints are quality of life, operation time, estimated blood loss, length of hospital stay, morbidity and mortality.DiscussionDGE after ppPD is a common complication with an incomplete understood aetiology. Prevention of DGE could improve outcomes and enhance quality of life after one of the most common procedures in pancreatic surgery. This trial will expand the existing evidence on intraoperative pyloromyotomy, and the results will provide additional data on a simple surgical technique that could reduce the incidence of postoperative DGE.Trial registrationGerman Clinical Trials RegisterDRKS00013503. Registered on 27 December 2017.
Highlights
Pylorus-preserving pancreaticoduodenectomy is a standard surgical procedure for the treatment of resectable neoplasms of the periampullary region
delayed gastric emptying (DGE) is a common complication after Pylorus-preserving pancreaticoduodenectomy (ppPD)
Intraoperative endoluminal pyloromyotomy could reduce the potential impact of pyloric dysregulation or pyloric spasm on the development of DGE after ppPD
Summary
Pylorus-preserving pancreaticoduodenectomy (ppPD) is a standard surgical procedure for the treatment of resectable neoplasms of the periampullary region. One of the most common postoperative complications after ppPD is delayed gastric emptying (DGE) which reduces quality of life, prevents a timely return to a solid oral diet and prolongs the length of hospital stay. The classical partial pancreaticoduodenectomy with resection of the distal stomach was modified by Traverso in the 1970s by introducing the pyloruspreserving technique (pylorus-preserving partial pancreaticoduodenectomy ppPD) [1]. Both procedures have been shown to be effective in terms of morbidity, overall survival and tumour recurrence [2, 3]. Severe cases may even lead to delayed initiation of subsequent therapeutic measures such as adjuvant chemotherapy [6]
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