These findings from the PENQUIN study appear in the Journal of the American Medical Association this week. They are from Dr. Olaf J. Bakker of University Medical Center Utrecht, the Netherlands, and the Dutch Pancreatitis Study Group.
Estimates are that each year in the United States more than 50,000 patients are admitted to the hospital with acute pancreatitis. Infectious pancreatic necrosis is one of the most devastating complications of acute pancreatitis and one that usually requires excision of necrotic tissue.
Traditional surgical necrosectomy induces a proinflammatory response and is associated with a high complication rate. Endoscopic transgastric necrosectomy is a less invasive approach to necrosectomy that potentially reduces the proinflammatory response and risk of procedure-related complications such as multiple organ failure.
In the PENQUIN trial, Dr. Bakker and colleagues compared the proinflammatory response and clinical outcome of endoscopic transgastric and surgical necrosectomy in 22 patients with infected necrotizing pancreatitis treated at four hospitals in the Netherlands between August 2008 and March 2010.
Endoscopic treatment was performed under conscious sedation and consisted of transgastric puncture, balloon dilatation, retroperitoneal drainage, and necrosectomy. Surgical treatment consisted of video-assisted retroperitoneal debridement or, if not feasible, laparotomy. There were 10 patients in the endoscopic arm and 12 in the surgical arm. Two patients in the surgical arm didn’t need necrosectomy following percutaneous catheter drainage.
The researchers report that compared with the surgical approach, the endoscopic approach significantly reduced the overall inflammatory state, as evidenced by significant reductions in serum levels of the proinflammatory cytokine IL-6 following the procedure (p=0.004).
In addition, the composite clinical endpoint of major complications (new-onset multiorgan failure, intra-abdominal bleeding, enterocutaneous fistula or pancreatic fistula) or death occurred less often after endoscopic necrosectomy than surgical necrosectomy (20% vs 80%; p=0.03).
There were no cases of new-onset multiorgan failure in the endoscopic arm compared with five in the surgical arm (0% vs 50%; p=0.03). There was one case of pancreatic fistula in the endoscopic arm and seven in the surgical arm (10% vs 70%; p=0.02). Five patients died; one in the endoscopic arm and four were in the surgical arm (10% vs 40%; p=0.30). All deaths were due to persistent multiorgan failure.
These “early, promising results require confirmation from a larger clinical trial,” Dr. Bakker and colleagues note in their report.
Dr. O. Joe Hines and Dr. Graham W. Donald, of the David Geffen School of Medicine at UCLA, Los Angeles, offer their thoughts on the study in a linked commentary. They make the point that while the difference in IL-6 levels between the endoscopic and surgical necrosectomy arms was “statistically significant and scientifically compelling, IL-6 has limited utility as a clinical decision-making tool.” The study researchers are “appropriately circumspect in describing their findings as preliminary,” Drs. Hines and Donald say.
They further note in their commentary that the recent PANTER trial (also from the Dutch Pancreatitis Study Group) demonstrated the advantages of percutaneous drainage as the initial treatment in patients with infected pancreatic necrosis. “This has become the standard surgical approach in many large centers,” Drs. Hines and Donald note, adding that there is evidence to suggest that it may now be “acceptable and preferred to perform drainage procedures earlier and, if possible, to delay more invasive interventions for at least a month.”
The current trial results “imply that endoscopic drainage, even if performed relatively earlier, will lead to fewer complications and less morbidity than open or even video-assisted necrosectomy. Although similar findings have been reported in case series, larger trials with more robust clinical end points (such as ongoing trials in the Netherlands) are needed to clearly establish the utility of endoscopic drainage in patients with infected pancreatic necrosis,” Dr. Hines and Dr. Donald conclude.
SOURCE: JAMA 2012;307:1053-1061,1084-1085.