Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial

Table 2 Composite primary endpoint

	DPCA	Management of pancreatic fistula	Validation database
Year(s)	2014–2015	2005–2013	2016
Patients	1686	309	174
Composite primary endpoint	12%	44%	15%
In patients undergoing pancreatoduodenectomy	14%	44%	17%
In patients undergoing distal pancreatectomy	7%	–	7%
Relative reduction between study groups	–	53%	–
Relative reduction between quartiles	62%	–	–

Incidence of the primary composite endpoint in three databases; “years” represents the time pancreatic resections were performed; “patients” represents the number of patients included in the analysis. “Management of pancreatic fistula” refers to Smits et al. JAMA Surg [9]. and includes only patients with severe pancreatic fistula; “validation study” refers to data used to validate the proposed algorithm
DPCA Dutch Pancreatic Cancer Audit

ISSN: 1745-6215