Less invasive endoscopies linked to better outcomes

According to a study published in the March 14 issue of JAMA, individuals with necrotizing pancreatitis who undergo endoscopic transgastric necrosectomy - a less-invasive procedure that involves the removal of the pancreatic tissue - were less likely to develop major complications or die, compared to those who received surgical necrosectomy. Necrotizing pancreatitis is a severe form of the disease that causes pancreatic tissue to die, resulting in increased bleeding. The researchers said: "Acute pancreatitis is a common and potentially lethal disorder. In the United States alone, more than 50,000 patients are admitted with pancreatitis each year. One of the most dreaded complications in these patients is infected necrotizing pancreatitis that leads to sepsis and is often followed by multiple organ failure. Most patients with infected necrotizing pancreatitis require necrosectomy. Surgical necrosectomy induces a proinflammatory response and is associated with a high complication rate." Endoscopic transgastric necrosectomy, a new method, is a form of natural orifice transluminal endoscopic surgery (NOTES). The procedure, which potentially lowers the proinflammatory response and risk of complications, such as multiple organ failure, does not require general anesthesia, as it can be performed under conscious sedation. To date, NOTES has not been compared with surgery in a randomized human trial for any disease. The randomized controlled human trial was conducted by Olaf J. Bakker, M.D., of University Medical Center Utrecht, the Netherlands, and colleagues in order to examine proinflammatory response and clinical outcome of surgical necrosectomy and endoscopic transgastric. The study was carried out between August 2008 and March 2010, in 1 regional teaching hospital and 3 academic hospitals in the Netherlands. The researchers randomly assigned the 22 study participants (who had signs of infected necrotizing pancreatitis and an indication for intervention) to receive either endoscopic transgastric or surgical necrosectomy. Participants assigned to the endoscopic necrosectomy group underwent necrosectomy, balloon dilatation, transgastric puncture, and retroperitoneal (a space in abdominal cavity) drainage. Participants assigned to surgical necrosectomy underwent video-assisted retroperitoneal debridement (surgical removal), or if not possible, a surgical incision into the abdominal wall called laparotomy. 2 of the study participants were unable to be examined for postprocedural proinflammatory response, as they did not undergo necrosectomy following percutaneous catheter drainage. The team discovered that serum interleukin 6 (IL-6) levels (a measure of proinflammatory response) increased after surgical necrosectomy, while these levels decreased after endoscopy. The researchers explained: "The composite clinical end point of death and major complications [new-onset multiple organ failure, intra-abdominal bleeding, enterocutaneous fistula (a connection between the intestine and the skin), or pancreatic fistula] was also reduced in the patients in the endoscopy group (20 percent vs. 80 percent). New-onset multiple organ failure did not occur after endoscopic transgastric necrosectomy (0 percent vs. 50 percent). Fewer patients in the endoscopic group developed pancreatic fistulas (10 percent vs. 70 percent)." Of the 20 participants, 5 died ( 40% of participants who received necrosectomy compared with 10% of those in the endoscopy group). All deaths were caused by persistent multiple organ failure. The researchers said: "The transition from open to laparoscopic surgery over the past 25 years greatly reduced surgical morbidity. Natural orifice transluminal endoscopic surgery has the potential for another quantum leap in improved surgical outcomes. In this first randomized clinical trial involving patients with infected necrotizing pancreatitis, endoscopic transgastric necrosectomy reduced the proinflammatory response as well as the composite clinical end point, including new-onset multiple organ failure, compared with surgical necrosectomy. However, these early, promising results require confirmation from a larger clinical trial." In an associated report, O. Joe Hines, M.D., and Graham W. Donald, M.D., of the David Geffen School of Medicine at UCLA, Los Angeles, explained: "Although the difference in IL-6 levels between the NOTES group and the surgical group was statistically significant and scientifically compelling, IL-6 has limited utility as a clinical decision-making tool." They note that the investigators with this trial: "Are appropriately circumspect in describing their findings as preliminary because the results may have been more robust if the trial recruitment period had been longer and more patients had been enrolled."