Preoperative biliary drainage (PBD) has been reported to increase complication rates after pancreatic head resection PHR). In some but not all studies PBD was associated with increased infection rates, more pancreatic fistulas or even higher mortality. In addition, the preoperative bilirubin level has been discussed as a potential factor influencing complication rate. To evaluate whether there are risk factors for postoperative complications in this subgroup of patients we analyzed postoperative complications in more than 200 patients undergoing PHR after previous PBD. METHODS: During a ten-year period 201 out of 462 patients undergoing PHR had had PBD. Indications for surgery were malignancies (66%) or benign (34%, most with chronic pancreatitis) disease. Operations performed were pylorus preserving PD (77%), classical Whipple procedure (9%), duodenum preserving resection (13%) and total pancreatectomy (2%). Perioperative data are prospectively documented in a computerized database. Risk factor analysis used current factors like sex, age (<60ys. vs. < 60 ys.), underlying disease (malignant vs. benign), preop. diabetes, type of surgery (duodenal preservation vs. not), type of PBD (percutaneous vs. endoscopic), preop. bilirubin and creatinine (normal vs. increased) and number of transfusions. Multivariate analysis was performed by binary logistic regression. Risk factors were identified with a forward selection strategy using the likelihood ratio statistic. RESULTS: Mortality was 2.5%. Postoperative complication rates were 42% (any), 29% (surgical) and 18% (infectious). Pancreatic leakage occurred in 12%. Preoperatively bilirubine was above the upper normal limit in 49% of the patients. Intraoperative bile cultures were positive in 88%. Multivariate analysis revealed preop. increased creatinine (in 12%) as an independent risk factor for all types of complication including pancreatic fistula (p<0.05 to <0.01). Further independent risk factors were the presence of diabetes (for wound infections only; p<0.05) and malignant disease (for pancreatic fistula only; p<0.04 vs. benign disease). Elevated bilirubine and positive bile cultures did not influence complication rates neither by uni- nor by multivariate analysis. CONCLUSIONS: In patients undergoing PHR after PBD bacterial colonization of the biliary tract and an increased bilirubine do not influence complication rates.