The most common presenting sign for patients with malignancy of the periampullary region is obstructive jaundice. While a significant proportion of these patients will be asymptomatic, the deleterious systemic consequences of uncontrolled hyperbilirubinemia may still occur. Furthermore, symptoms such as pruritus can be debilitating and have a significant impact on the quality of life. Thus, some have advocated preoperative drainage of the biliary system in patients with resectable periampullary malignancies, given widespread availability of endoscopic retrograde cholangiopancreatography and its perceived safety profile. On the other hand, the purported benefits of routine preoperative drainage in this patient population (namely, resolution of symptoms in symptomatic patients while awaiting surgery, restoration of the enterohepatic cycle, and a potential decrease in postoperative morbidity) have proven to be largely theoretical, and now there are high-quality phase III data that demonstrate the deleterious effects of routine stenting. A seminal study originating from the Netherlands in 2010 evaluated this issue in the only modern randomized controlled trial to date evaluating preoperative endoscopic biliary decompression for these patients. In their multicenter study, they randomized 202 patients with newly diagnosed pancreatic head cancer and bilirubin levels between 2.3 and 14.6 mg/dL to preoperative biliary drainage for 4–6 weeks vs. immediate surgery which was to be performed within a week of enrollment. The primary endpoint was the development of serious complications within 120 days after randomization. Serious complications were defined as complications related to the drainage procedure or the surgical intervention that required additional medical, endoscopic, or surgical management, and that resulted in prolongation of the hospital stay, readmission to the hospital, or death. The reported overall rate of serious complications in this study favored the immediate surgery group (39 vs. 74%; RR 0.54–95% [CI], 0.41–0.71; P < 0.001), complications related to surgery were equivalent (37 vs. 47%; P = 0.14), and there was no difference in mortality rates or length of hospital stay. The observed drainage-related complications included a 15% rate of stent occlusion, 30% need for exchange, and 26% incidence of cholangitis.
“Based on these results, the authors concluded that the morbidity associated with the drainage procedure itself had an additive effect on the postoperative morbidity of patients undergoing pancreatic head resection for cancer and recommended against its routine use in this population.“
A Cochrane systematic review of all available randomized studies (including the abovementioned study by van der Gaag et al.) evaluating preoperative biliary drainage was published in 2012. In this study, Fang et al. assessed the impact of this intervention on survival, serious morbidity (defined as Clavien-Dindo grade 3 or 4), and quality of life. Furthermore, they sought to assess differences in total length of hospital stay and cost. They identified six randomized trials of which four used percutaneous transhepatic biliary drainage and the remaining two used endoscopic sphincterotomy and stenting. The pooled analysis of 520 patients (of which 51% underwent preoperative biliary drainage) showed no difference in mortality, but importantly, it showed a significantly higher incidence of serious morbidity in the preoperative drainage group with a rate ratio (RaR) of 1.66 (95% CI 1.28–2.16;P = 0.002). There was no difference in length of hospital stay and not enough data reported for analysis of cost or quality of life.
“Based on the available level 1 data, the authors concluded that there was no evidence to support or refute routine preoperative biliary drainage in patients with obstructive jaundice.“
However, this review also underscored the fact that preoperative biliary drainage may be associated with an increased rate of adverse events and thus questioned the safety of this practice. This Cochrane review included old studies that evaluated patients undergoing percutaneous drainage, a technique used less frequently today for periampullary malignancies. Furthermore, several of these trials included patients with hilar and other types of biliary obstruction. However, the concept of preoperative decompression, as well as its purported benefits and observed results, may be reasonably extrapolated to patients with periampullary lesions.
The SURGEON 