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Lumen-apposing metal stents (LAMS) have been recently developed to improve treatment outcomes in the endoscopic management of pancreatic fluid collections (PFC), particularly in walled-off necrosis (WON), to facilitate better drainage of necrotic contents and minimise the risk of perforation and peritoneal leakage. In an ongoing randomised trial, we observed serious adverse events that included delayed bleeding, buried stent syndrome and biliary stricture that necessitated a change in the management protocol for patients with PFC treated with LAMS.
In more detail
Randomised trials comparing endoscopic and surgical techniques for the management of PFCs have favoured the endoscopic approach.1 ,2 Endoscopy is less expensive, associated with shorter hospital stay and the clinical outcomes are comparable. To compare the clinical outcomes of patients undergoing endoscopic drainage of WON using LAMS or plastic stents, a randomised trial (NCT02685865) was initiated at our institution. Included in the study were patients with symptomatic WON measuring >6 cm in size and located adjacent to the gastric or duodenal lumen. Excluded were patients with pseudocysts, WON inaccessible for endoscopic ultrasound-guided drainage and irreversible coagulopathy. The LAMS (Hot AXIOS, Boston Scientific) used in this trial had a single-step cautery-tipped delivery system with dimensions of 15 mm (diameter) by 10 mm (length). In the plastic stent cohort, two 7 Fr by 4 cm double pigtail stents were deployed after dilation of the transmural tract to 12 mm. Per study protocol, a follow-up CT was obtained at 4–6 weeks after the index intervention to assess treatment response with treatment success defined as resolution of WON to <3 cm in conjunction with symptom relief. The main outcome measure was to compare the median number of interventions required to achieve treatment success. The secondary outcome measures were to compare the rates of treatment success and clinical and stent-related adverse events. The total sample size was estimated at 62 patients.
In this ongoing …
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