For decades, pancreatic surgeons were taught to place a drain after pancreatic resection. Pancreatic resection outcomes have improved and there is a growing tendency to perform pancreatectomy without the use of drainage. This shift in clinical practice has been supported by lower levels of evidence, such as case series and cohort studies. We are concerned that this trend may threaten improvements and result in worse patient outcomes. Our group was the first to perform a multicenter randomized prospective clinical trial to address this question. We found that morbidity and mortality were increased after pancreaticoduodenectomy without routine drainage. This finding was in contrast with our own previously reported case series. We now believe it is critically important to ask this question in the setting of distal pancreatectomy. We propose to test the hypothesis that distal pancreatectomy without the use of routine intraperitoneal drainage increases the 60-day overall complication rate or severity of complications. Patients will be randomized to distal pancreatectomy with and without the use of routine intraperitoneal drainage. The safety of this approach and the spectrum of complications will be compared. If distal pancreatectomy without drainage is proven to increase complications, this study will reverse the national trend to eliminate routine drainage and decrease complications and costs of distal pancreatectomy. In addition, we will establish a pancreatic surgery outcomes consortium to provide detailed data necessary to improve outcomes and decrease cost of care. Although national health services and administrative databases have been valuable to study outcomes after pancreatic resection, they have limited ability to answer certain important questions by the lack of depth and, in some cases, accuracy of the data elements. We propose an innovative and collaborative approach to data collection in the field of pancreatic surgery: use of a common electronic database with clearly defined and well thought out universal data elements. Our strategy involves centralized electronic collection of de-identified data into a common repository and centralized collection of source documents for quality assurance measures. Our innovative system is scalable and can potentially become a permanent prospective data repository for pancreatic surgery, lead to a better understanding of surgical outcomes in our field, and influence novel strategies.
Operations on the pancreas have become safer in recent years but remain a significant challenge because pancreas juice can leak out from the cut margin of the pancreas. Surgeons have traditionally placed drains near the pancreas to remove any pancreas juice that may leak after surgery, but there is debate about whether or not this is necessary. This study will compare the results of pancreas surgery with or without a drain.
| Villafane-Ferriol, Nicole; Van Buren 2nd, George; Mendez-Reyes, Jose E et al. (2018) Sequential drain amylase to guide drain removal following pancreatectomy. HPB (Oxford) 20:514-520 |
