麻豆传媒

Upfront endoscopic necrosectomy may be suitable for certain patients with confirmed or suspected infected necrotizing pancreatitis, results of a small randomized trial suggested.

In 70 patients undergoing drainage with endoscopic transluminal stenting, upfront necrosectomy immediately afterward led to fewer subsequent interventions to achieve treatment success compared with when this procedure was reserved for stubborn cases (median one vs two reinterventions over a 6-month period, P=0.0027), reported Shyam Varadarajulu, MD, of the Orlando Health Digestive Health Institute in Florida, and colleagues.

More patients in the upfront group had zero or only one reintervention (81% vs 45% in the step-up group), and far fewer required three or more reinterventions (5% vs 42%).

Varadarajulu's group ultimately concluded that in stable patients with extensive necrosis, such as those in the trial, upfront endoscopic necrosectomy could be beneficial.

"Although we found no significant difference in treatment success and adverse events, such an approach could expedite clinical recovery, minimize the need for reinterventions, and shorten the length of hospital stay and, thereby, reduce healthcare costs," they wrote in .

Each year in the U.S., acute pancreatitis is responsible for upwards of 275,000 hospitalizations, with roughly one in five of these patients going on to develop necrosis. The condition carries a high mortality rate, increasing further when organ failure and infected necrotic tissue are involved.

In recent years, open surgery has been replaced by the step-up approach -- wherein patients initially receive broad spectrum antibiotics, drainage of necrotic collections, and finally necrosectomy for non-responders. This move followed the publication of showing lower rates of complications and mortality.

But by design, the step-up approach "is associated with the need for multiple reinterventions and prolonged hospitalization and, therefore, the optimal treatment approach remains unclear," Varadarajulu and co-authors explained.

Patients in the study were generally stable at the time of the initial intervention, as demonstrated by their organ failure rate of 10%. Of note, only 79% of those assigned to the step-up group ultimately underwent necrosectomy.

"This important observation by the authors suggests that necrosectomy might not be required in all patients with infected necrotizing pancreatitis," said Deepak Gunjan, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues, writing in a . And this is in line with past studies suggesting that two-thirds of patients can improve with antibiotics and drainage alone.

However, wrote Gunjan and his fellow commentators, "certain factors could predict the need for necrosectomy, such as the extent of necrotic debris of more than 30%, paracolic extension of the collections, the presence of organ failure, and infection with multidrug-resistant organisms."

Varadarajulu's team agreed that upfront necrosectomy is certainly not for all patients and cautioned that it "could even be potentially harmful in patients with acute necrotic collections or in unstable patients during early phases of illness when drainage could be the only safe treatment option."

From 2019 to 2022, the single-blinded screened 183 adults with confirmed or suspected infected necrotizing pancreatitis at five hospitals in the U.S. and one in India, ultimately randomizing 37 patients to upfront necrosectomy and 33 to the step-up treatment approach. Eligibility criteria required a necrosis extent of 33% or more.

All patients underwent endoscopic transluminal stenting with lumen-apposing metal stents, with intravenous antibiotics given pre- and post-procedurally. If assigned to the upfront approach, patients received the endoscopic necrosectomy during the same treatment session as the stenting. In the step-up group, a lack of clinical improvement at 72 hours post-stenting indicated reintervention with either further drainage or necrosectomy.

Average participant age was about 50 years, and two-thirds were men, with 56% white, 27% Asian, and 13% Hispanic. Most patients (91%) had walled-off necrosis, and the median necrosis extent reached 50% in each arm.

At the index presentation, systemic inflammatory response syndrome was present in 89% of study participants, while 34% had single-organ failure, a third had multi-organ failure, and 20% had sepsis. At the time of initial intervention, these rates were 63%, 4%, 6%, and 20%, respectively.

At 72 hours after the index intervention, significantly more patients assigned to upfront necrosectomy had clinical improvement (76% vs 52% in the step-up group, P=0.035), with improvement defined as resolution of systemic inflammatory response syndrome, sepsis, or organ failure, along with a 25% decrease in necrotic collection size.

Patients assigned to the upfront necrosectomy were also discharged earlier (median 9 vs 19 days, P=0.048), and while not statistically different, the upfront approach was associated with a numerically lower total treatment cost ($576,182 vs $847,567).

Regardless of the approach, the study found no significant difference in the overall rate of treatment success (100% with upfront necrosectomy vs 94% with the step-up approach) or mortality (none vs two), and investigators observed no significant differences when it came to disease-related adverse events (32% vs 48%) or procedure-related adverse events (11% vs 24%).

Varadarajulu and colleagues acknowledged that a composite endpoint incorporating mortality, adverse events, and reinterventions may have been more optimal than their primary endpoint. They also noted that endoscopic treatment is not standardized and should only be performed in expert centers with a multidisciplinary support team to manage adverse events.

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