Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Abstract

ObjectiveLumen-apposing metal stents (LAMS) are believed to clinically improve endoscopic transluminal drainage of infected necrosis when compared with double-pigtail plastic stents. However, comparative data from prospective studies are very limited.DesignPatients with infected necrotising pancreatitis, who underwent an endoscopic step-up approach with LAMS within a multicentre prospective cohort study were compared with the data of 51 patients in the randomised TENSION trial who had been assigned to the endoscopic step-up approach with double-pigtail plastic stents. The clinical study protocol was otherwise identical for both groups. Primary end point was the need for endoscopic transluminal necrosectomy. Secondary end points included mortality, major complications, hospital stay and healthcare costs.ResultsA total of 53 patients were treated with LAMS in 16 hospitals during 27 months. The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)). Secondary end points did not differ between groups either, which also included bleeding requiring intervention—5 patients (9%) after LAMS placement vs 11 patients (22%) after placement of plastic stents (relative risk 0.44; 95% CI 0.16 to 1.17). Total healthcare costs were also comparable (mean difference −€6348, bias-corrected and accelerated 95% CI −€26 386 to €10 121).ConclusionOur comparison of two patient groups from two multicentre prospective studies with a similar design suggests that LAMS do not reduce the need for endoscopic transluminal necrosectomy when compared with double-pigtail plastic stents in patients with infected necrotising pancreatitis. Also, the rate of bleeding complications was comparable.

Lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis: more doubts than answers

“…We read with great interest the study published by Boxhoorn et al , comparing lumen-apposing metal stents (LAMS) versus double-pigtail plastic stents (DPPS) for treatment of infected necrotising pancreatitis 1. The authors did not find a significant difference in the primary aim, that is, the need for endoscopic transluminal necrosectomy, based on an indirect comparison between a multicentre prospective cohort treated with LAMS (step-up approach) and a previous cohort from the TENSION randomised controlled trial (RCT), where patients were treated with DPPS according to a similar protocol 2…”

“…When patients in a single study are treated by several therapists, there is good reason to suspect that variation in outcome will be smaller for patients treated in the same group than for patients treated in different groups. This potential correlation of outcomes results in a loss of independence of observations, in particular when the number of patients enrolled per centre is different, as could have occurred in the study by Boxhoorn et al 1. As a consequence, reporting this information and accounting for clustering through several statistical methods, such as randomising patients within each cluster, would represent a strength in these multicentre studies 5…”

“…One unclear choice in the study by Boxhoorn et al 1 was placement of a 7 Fr nasocystic catheter through the LAMS, which are used instead of DPPS with the assumption that the larger lumen would expect to facilitate drainage, making additional flushing through the catheter theoretically unnecessary. Moreover, the nasocystic catheter was arbitrarily left in place for 1 week, a time not sustained by any available evidence.…”

A novel mini-invasive step-up approach for the treatment of severe acute pancreatitis with extensive infected necrosis: a single center case series study

“…However, the endoscopic operation time was shorter in patients with LAMS despite the higher incidence of complications and costs. In contrast, another prospective cohort study enrolled 53 patients with IPN and found that the number of endoscopic transluminal necrosectomy procedures, incidence of complications, and total healthcare costs were comparable between the two stents 33 . The results of two ongoing randomized controlled studies will further evaluate the clinical e cacy and possible complications 34,35 ; however, shorter endoscope operation times with LAMS are unambiguously evident, which is a potentially crucial advantage for more critical cases 12,32 .…”

“…Patients with LAMS had a higher clinical success rate, shorter procedure time, and a lower probability of requiring surgery and recurrence than those with plastic stents. However, two recent prospective studies evaluating the clinical effects and associated complications of LAMS have shown mixed results 32,33 . In a randomized controlled trial by Bang et al involving 60 patients with pancreatitis and walled-off necrosis, patients with LAMS had similar technical success, treatment success, and the total number of procedures performed during the 6 months of follow-up was comparable to that obtained following placement of plastic stents 32 .…”