Reuters Health Information (2010-01-13): Preoperative biliary drainage ups complications with pancreatic cancer surgery
Preoperative biliary drainage ups complications with pancreatic cancer surgery
Last Updated: 2010-01-13 17:00:28 -0400 (Reuters Health)
NEW YORK (Reuters Health) - The risks of complications from preoperative biliary drainage appear to outweigh the benefits in patients with potentially resectable cancer of the pancreatic head, new research suggests.
That conclusion is based on a randomized trial conducted in the Netherlands and reported in The New England Journal of Medicine for January 14. The findings indicate that roughly three-quarters of patients who undergo preoperative drainage will experience a serious complication within 6 months, whether related to that procedure or to subsequent resection.
"The exact benefit of preoperative biliary drainage is unclear," first author Dr. Niels A. van der Gaag told Reuters Health. "Available literature is characterized by relatively old studies with poor methodology and small sample sizes that employ outmoded drainage techniques. Early studies showed beneficial effects, whereas more recent studies challenged those results and suggested no clear benefit."
The lack of studies evaluating modern drainage techniques, and the fact that biliary drainage is common practice in many countries, led the investigators to study 196 patients with cancer of the pancreatic head, obstructive jaundice, and a bilirubin level of 2.3 to 14.6 mg/dL, who were treated between 2003 and 2008.
They randomly assigned patients to undergo either biliary drainage 4 to 6 weeks before surgery (n = 102), or surgery alone within 1 week after randomization (n = 94).
In the early surgery group, 5 patients had preoperative biliary drainage anyway and 2 had surgery deferred. Six patients in the biliary drainage group did not actually undergo the procedure, and 7 patients in that group had surgery deferred. Ultimately, 67% of patients in the early-surgery group and 56% in the biliary drainage group had pancreatic resections.
One or more attempts at biliary drainage, primarily by endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement, were successful in 94% of patients. Jaundice resolved within 10 days after successful drainage. However, drainage-associated complications developed in 46% of patients. The most common serious complication of biliary drainage was cholangitis, followed by pancreatitis, perforation, and hemorrhage.
The most frequent adverse events following surgery were pancreaticojejunostomy leakage, delayed gastric emptying, wound infection, and pneumonia, and did not differ significantly between groups.
Overall, the cumulative rates of serious complications within 120 days after randomization were 39% in the early-surgery group and 74% in the biliary-drainage group (relative risk 0.54, p < 0.001).
Twelve patients in the early surgery group and 15 in the biliary drainage group died (p = ns). Median lengths of hospital stay were 14 and 16 days, respectively.
"If early surgical capacity is available, patients should undergo early surgery," Dr. van der Gaag recommended. "Candidates for preoperative biliary drainage might be those with very high bilirubin levels (>300 micromoles/L) and severe malnutrition."
He acknowledged that early surgery is not always possible due to waiting lists, geographical distances, and scheduling difficulties. In such cases, when biliary drainage is required, "this does not adversely affect post surgical morbidity and mortality," he added. "But overall costs of treatment increase when preoperative biliary drainage is performed."
The authors of an accompanying editorial - Dr. Todd H. Baron, from the Mayo Clinic in Rochester, Minnesota, and Dr. Richard A. Kozarek, from Virginia Mason Medical Center, Seattle - comment that these findings "should give pause to both our surgical and endoscopic colleagues before they automatically perform ERCP and stent placement in such patients."
They remark that preoperative biliary drainage should be limited primarily to patients with acute cholangitis and those with intense pruritus in whom surgery is delayed.
In these patients, they add, complications may be reduced if self-expandable metallic stents are substituted for plastic stents, since they tend to have longer patency and fewer stent-related problems.
N Engl J Med 2010;362:129-137,170-171.