Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial)

Patients with obstructive jaundice due to a periampullary tumor, eligible for exploration after staging with CT scan, and scheduled to undergo a "curative" resection, will be randomized to either "early surgical treatment" (within one week) or "preoperative biliary drainage" (for 4 weeks) and subsequent surgical treatment (standard treatment). Primary outcome measure is the percentage of severe complications up to 90 days after surgery. The sample size calculation is based on the equivalence design for the primary outcome measure. If equivalence is found, the comparison of the secondary outcomes will be essential in selecting the preferred strategy. Based on a 40% complication rate for early surgical treatment and 48% for preoperative drainage, equivalence is taken to be demonstrated if the percentage of severe complications with early surgical treatment is not more than 10% higher compared to standard treatment: preoperative biliary drainage. Accounting for a 10% dropout, 105 patients are needed in each arm resulting in a study population of 210 (alpha = 0.95, beta = 0.8).The DROP-trial is a randomized controlled multicenter trial that will provide evidence whether or not preoperative biliary drainage is to be performed in patients with obstructive jaundice due to a periampullary tumor.Patients with obstructive jaundice caused by a tumor in the pancreatic head area (pancreas, distal bile duct, papilla of Vater), without radiological evidence of irresectability, will undergo an exploration with the intention of resection of the tumor, being the only option for cure [1-4]. If a resection is not possible due to locoregional irresectability or distant metastases, a biliary and gastric bypass procedure is performed [5-8]. Surgery in jaundiced patients with a tumor in the pancreatic head area is associated with a higher risk of postoperative complications compared with surgery in non jaundiced patients [9-11]. These complications primarily consist of septic complications