Long-term results of a prospective study comparing lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotizing pancreatitis

Aims In our recent multicentre prospective study (AXIOMA study), the effectiveness of lumen-apposing metal stents (LAMS) in endoscopic transluminal drainage of infected necrosis was comparable to that of double-pigtail plastic stents. In this study, we aimed to asees the long-term outcomes (> 6 months) of the stents [1].

Methods We examined the long-term outcomes of patients with infected necrotizing pancreatitis enrolled in two prospective studies. Patients were treated with endoscopic transluminal drainage with LAMS (n=52) or with double-pigtail plastic stents (n=48). The protocol of both studies, including in- and exclusion criteria, were identical except for the type of transluminal stent. The primary endpoint was the proportion of patients requiring additional endoscopic, percutaneous or surgical drainage procedures due to (recurrence of) symptomatic or infected (peri-)pancreatic collections. Secondary endpoints included the individual components of the primary endpoint, major complications, mortality, number of (pancreatitis-related) readmissions and interventions, length of hospital stay, pancreatic function and quality of life.

Results The median follow-up period was 4 years. By the end of this period, 77 out of 100 patients were still alive. Among the 47 surviving patients treated with LAMS, 9 were lost to follow-up after the initial 6-month study. An additional percutaneous, endoscopic or surgical drainage or necrosectomy procedure was needed in 37 patients (77%) in the plastic stent group and 40 patients (77%) in the LAMS group (RR 1.002 95% CI 0.809-1.242). The median number of interventions for infected necrosis did not differ during overall follow-up (2 [IQR, 1–5] vs 2 [IQR, 1.5–7.5], respectively, P=0.66). Overall, there was no significant difference in mortality rates (12 patients (25%) vs. 11 (21%) respectively; RR 1.18 95% CI 0.576–2.42), and there was no difference in new mortality after the initial follow-up of 6 months (3 patients (8%) vs. 6 (13%) respectively; RR 0.603 95% CI 0.16–2.254). No deaths during long-term follow-up were related to pancreatitis. The plastic stents group and LAMS group had a similar rate of pancreatitis-related readmissions (2 [IQR, 0–2] vs 1 [IQR, 0–3], P=0.67) and associated length of hospital stay (9 [IQR, 0–20.75] vs 6 [IQR, 0–19.75, P=0.58).

Conclusions During the long-term follow-up of the AXIOMA study participants, we found no differences in mortality, major complications, readmissions or the need for additional drainage or necrosectomy interventions between double-pigtails plastic stents and LAMS. These long-term results are consistent with our prior findings suggesting that double-pigtail plastic stents and LAMS in have comparable clinical outcomes and adverse events rates in the endoscopic step-up approach for infected necrotizing pancreatitis.

Publication History

Article published online:
27 March 2025

• References

• 1 Boxhoorn L, Verdonk R, Besselink M, Boermeester M, Bollen T, Bouwense S. et al. Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis. Gut 2023; 72 (01): 66