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. 2025 Sep 23:gutjnl-2025-335067.
doi: 10.1136/gutjnl-2025-335067. Online ahead of print.

Real-world impact of implementing lumen-apposing metal stents for pancreatic fluid collections: a nationwide Japanese study

Tsuyoshi Hamada  1   2 , Nobuaki Michihata  3 , Tomotaka Saito  4 , Yuya Kimura  5 , Takuji Iwashita  6 , Hiroki Matsui  7 , Hideyuki Shiomi  8 , Mamoru Takenaka  9 , Keisuke Iwata  10 , Akinori Maruta  11 , Atsuhiro Masuda  12 , Saburo Matsubara  13 , Kiyohide Fushimi  14 , Ichiro Yasuda  15 , Hiroyuki Isayama  16 , Hideo Yasunaga  7 , Yousuke Nakai  4   17 ; WONDERFUL study group in Japan and collaborators
Collaborators, Affiliations

Real-world impact of implementing lumen-apposing metal stents for pancreatic fluid collections: a nationwide Japanese study

Tsuyoshi Hamada et al. Gut. .

Abstract

Background: Lumen-apposing metal stents (LAMSs) are increasingly used for the endoscopic management of pancreatic fluid collections (PFCs), including walled-off necrosis (WON) and pancreatic pseudocysts (PCs).

Objective: To evaluate the nationwide impact of implementing an LAMS (approved in Japan in 2018) on clinical outcomes in real-world settings.

Design: Using a nationwide inpatient database, we identified 5885 patients who underwent endoscopic ultrasound (EUS)-guided treatment for PFCs at 550 hospitals between 2010 and 2023. We examined the association between treatment period (pre-LAMS vs post-LAMS implementation) and clinical outcomes. Multivariable logistic and linear regression analyses were performed to estimate ORs and coefficients, respectively. Findings were validated using a multi-institutional clinical cohort (n=618) from specialty hospitals with more detailed clinical parameters with data collection during the same period.

Results: In the pre-LAMS period, 3787 cases were treated exclusively with plastic stents. After 2018, LAMS use stabilised at around 50% among 2098 cases treated between 2019 and 2023. Compared with the pre-LAMS period, patients treated during the post-LAMS period had a higher risk of bleeding with LAMS (adjusted OR, 1.81; 95% CI: 1.55 to 2.13), but not with plastic stents (adjusted OR, 0.96; 95% CI: 0.74 to 1.26). Rates of rescue surgery, in-hospital mortality and length of stay did not differ significantly (p>0.12). The post-LAMS period was associated with increased total costs (adjusted coefficient, US$2813; 95% CI: 1503 to 4122). In analyses stratified by PFC types (WON vs PC), the association of the post-LAMS period with bleeding risk appeared to be stronger for PCs than WON (pinteraction=0.015) and WON patients had a shorter length of stay and lower total costs in the post-LAMS period (pinteraction<0.001). In the validation cohort, the elevated bleeding risk with LAMS was confirmed (adjusted OR, 1.59; 95% CI: 0.86 to 2.95, vs pre-LAMS period), though not statistically significant.

Conclusions: The implementation of LAMS was not associated with improved key clinical outcomes but was linked to a higher risk of bleeding and increased healthcare costs. These findings do not support the routine use of LAMS for EUS-guided treatment of all PFCs in standard clinical practice but may restrict it to WON cases with clear indications.

Keywords: ACUTE PANCREATITIS; EPIDEMIOLOGY; PANCREATIC PSEUDOCYST; STENTS.

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Conflict of interest statement

Competing interests: HI and YN receive research funding and honoraria from Boston Scientific Japan. This work was not funded by this company. No other conflicts of interest exist. The other authors declare that they have no conflicts of interest.