Patients with infected necrotizing pancreatitis fared no better after immediate catheter drainage than those who underwent the more conservative postponed drainage approach, according to results from a recent superiority study. In fact, patients in whom drainage was postponed—who also received antibiotics—needed fewer invasive interventions and had fewer complications than those who underwent immediate drainage.
Researchers concluded that conservative initial treatment with antibiotics in patients with infected necrosis is justified. They published their results in The New England Journal of Medicine.
“The mortality rate for infected necrotizing pancreatitis is high. We felt we could improve outcomes by draining infected necrosis earlier and more ’aggressively’ like we are doing for complications of pancreatic surgery. This has really improved outcomes in this field,” researcher Marc G. Besselink, MD, PhD, of Amsterdam UMC, University of Amsterdam, the Netherlands, told BreakingMED in an email correspondence. “Currently, antibiotics and draining infected necrosis using transgastric or percutaneous drains [are used and] sometimes removing the necrosis (i.e., necrosectomy) either transgastrically or minimally invasive via the retroperitoneum.”
For this multicenter, randomized, superiority trial, Besselink and colleagues randomized patients with infected necrotizing pancreatitis (mean age: roughly 60 years) to drainage within 24 hours of a diagnosis of infected necrosis (n=104) or postponed drainage until walled-off necrosis was reached (n=49).
The Comprehensive Complication Index—comprised of all complications over 6-month follow-up—was the primary end point of the study. These scores range from 0 to 100, and higher scores indicated more severe complications; researchers found no between-group differences in this outcome. In patients treated with immediate draining, the mean Comprehensive Complication Index score was 57, compared with 58 in the postponed-drainage group, for a mean difference of −1 (95% CI: −12 to 10; P=0.90).
The incidence of major complications was similar in the two groups, including new-onset organ failure at 25% in patients treated with immediate drainage versus 22% in those in whom drainage was postponed (RR: 1.13; 95% CI: 0.57-2.26); bleeding (15% vs 20%, respectively; RR: 0.71; 95% CI: 0.31-1.66); visceral organ perforation, enterocutaneous fistula, or both (9% vs 8%; RR: 1.11; 95% CI: 0.32-3.91); pancreaticocutaneous fistula (11% vs 8%; RR: 1.34; 95% CI: 0.40-4.46); and wound infection (0% vs 1%). No instances of incisional hernia occurred in either group. Mortality was also similar between the two groups, at 13% versus 10%, respectively (RR: 1.25; 95% CI: 042-3.68).
Patients undergoing immediate draining underwent a mean of 4.4 interventions, compared with 2.6 in those treated with postponed drainage (mean difference: 1.8; 95% CI: 0.6-3.0), and had a length of hospital stay that was a mean of 8 days longer (59 vs 51 days, respectively; 95% CI: −9 to 23).
In all, 19 patients (39%) undergoing postponed drainage were treated conservatively with antibiotics, and drainage was not necessary. Seventeen of these patients survived. Over 50% of patients undergoing immediate drainage required necrosectomy, compared with 22% in those in whom drainage was postponed. Adverse events were similar in both groups.
“In patients with infected necrosis, early drainage does not improve outcome. Clinicians can await the impact of antibiotic treatment, more than a third of the patients will recover with antibiotics only. Surprisingly, such a conservative approach will not lead to delayed recovery but will actually shorten hospital stay,” concluded Besselink.
Yet these findings go against the original hypothesis of these researchers. Are they surprising? According to Besselink, “They are pretty surprising, especially since we were expecting the opposite effect (better recovery with early drainage). On the other hand, we know that pancreatitis does not behave like any other gastrointestinal disease, and the POINTER trial results once more confirm this.”
“This trial adds to the growing volume of high-quality studies guiding evidence-based recommendations. The management of acute necrotizing pancreatitis is now predominately nonsurgical,” wrote Todd H. Baron, MD, of the University of North Carolina at Chapel Hill, in an accompanying editorial. “As shown in the present study, nonoperative drainage in clinically stable patients is best delayed until the development of walled-off necrosis, which usually occurs 30 or more days after the onset of pancreatitis.”
Limitations of the study included the use of the Comprehensive Complication Index originally developed to assess postoperative complications, the inclusion of both endoscopic and surgical step-up approaches, and disqualification of many patients in whom infected necrosis was diagnosed after the trial’s 35-day cutoff and those in whom drainage had already been performed and in whom drainage postponement was not feasible.
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Immediate catheter drainage in patients with infected necrotizing pancreatitis was not superior to postponed catheter drainage in reducing complications.
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In these patients, researchers support the use of a postponed drainage strategy that includes antibiotic treatment.
Liz Meszaros, Deputy Managing Editor, BreakingMED™
Supported by Fonds NutsOhra, the Netherlands, and the Amsterdam UMC, University of Amsterdam.
Besselink had no relevant relasionships to disclose.
Baron reported receiving personal fees from Cook Endoscopy, Boston Scientific, Ambu, W.L. Gore, Olympus, and Medtronic, outside the submitted work.
Cat ID: 112
Topic ID: 77,112,521,791,730,187,112,188,192,925
