1. Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial)
- Author
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Smits, F.J., Henry, A.C., Eijck, C.H. van, Besselink, M.G., Busch, O.R., Arntz, M., Bollen, T.L., Delden, O.M. van, Heuvel, D. van den, Leij, C. van der, Lienden, K.P. van, Moelker, A., Bonsing, B.A., Rinkes, I.H.M.B., Bosscha, K., Dam, R.M. van, Festen, S., Koerkamp, B.G., Harst, E. van der, Hingh, I.H. de, Kazemier, G., Liem, M., Kolk, B.M. van der, Meijer, V.E. de, Patijn, G.A., Roos, D., Schreinemakers, J.M., Wit, F., Werkhoven, C.H. van, Molenaar, I.Q., Santvoort, H.C. van, Dutch Pancreatic Canc Grp, Surgery, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and Quality of Life, AGEM - Endocrinology, metabolism and nutrition, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA -Cancer Center Amsterdam, Other Research, Groningen Institute for Organ Transplantation (GIOT), Center for Liver, Digestive and Metabolic Diseases (CLDM), Radiology & Nuclear Medicine, CCA - Cancer Treatment and quality of life, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: NUTRIM - R2 - Liver and digestive health, and MUMC+: MA Heelkunde (9)
- Subjects
Male ,Percutaneous ,Cost effectiveness ,SURGERY ,medicine.medical_treatment ,Cost-Benefit Analysis ,INTERNATIONAL STUDY-GROUP ,Medicine (miscellaneous) ,GUIDELINES ,COST-EFFECTIVENESS ,Study Protocol ,Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] ,0302 clinical medicine ,Postoperative Complications ,Clinical endpoint ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Cluster randomised controlled trial ,Netherlands ,lcsh:R5-920 ,COMPLICATIONS ,Disease Management ,EDUCATION ,Pancreaticoduodenectomy ,Pancreatic fistula ,030220 oncology & carcinogenesis ,PANCREATICODUODENECTOMY ,Health Resources ,Female ,lcsh:Medicine (General) ,Algorithm ,Algorithms ,Multiple Organ Failure ,Hemorrhage ,CLASSIFICATION ,03 medical and health sciences ,Pancreatic Fistula ,Pancreatectomy ,All institutes and research themes of the Radboud University Medical Center ,Humans ,Pancreas ,business.industry ,Other Research Radboud Institute for Health Sciences [Radboudumc 0] ,Consolidated Standards of Reporting Trials ,medicine.disease ,Early Diagnosis ,DEFINITION ,SAMPLE-SIZE ,Complication ,business ,Delivery of Health Care - Abstract
Background Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection. Methods This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains). The algorithm is designed to aid early detection and minimally invasive step-up management of postoperative pancreatic fistula. Outcomes of current practice will be compared with outcomes after implementation of the algorithm. The primary outcome is a composite of major complications (i.e. post-pancreatectomy bleeding, new-onset organ failure and death) and will be measured in a sample size of at least 1600 patients undergoing pancreatic resection. Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization and costs analysis. Follow up will be up to 90 days after pancreatic resection. Discussion It is hypothesized that a structured nationwide implementation of a dedicated algorithm for early detection and minimally invasive step-up management of postoperative pancreatic fistula will reduce the risk of major complications and death after pancreatic resection, as compared to current practice. Trial registration Netherlands Trial Register: NL 6671. Registered on 16 December 2017.
- Published
- 2020
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