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Multicenter Study
. 2025 Jul;102(1):67-78.e3.
doi: 10.1016/j.gie.2024.12.037. Epub 2025 Jan 8.

Quadrant, necrosis, and infection criteria for the risk stratification of walled-off necrosis: external validation using multi-institutional data

Hideyuki Shiomi  1 , Tomotaka Saito  2 , Tsuyoshi Hamada  3 , Ryota Nakano  4 , Shunsuke Omoto  5 , Mamoru Takenaka  5 , Masahiro Tsujimae  6 , Atsuhiro Masuda  6 , Shogo Ota  4 , Shinya Uemura  7 , Takuji Iwashita  7 , Sho Takahashi  8 , Toshio Fujisawa  8 , Kentaro Suda  9 , Saburo Matsubara  9 , Kensaku Yoshida  10 , Akinori Maruta  10 , Yuhei Iwasa  11 , Keisuke Iwata  11 , Nobuhiko Hayashi  12 , Tsuyoshi Mukai  13 , Hiroyuki Isayama  8 , Ichiro Yasuda  12 , Yousuke Nakai  14 ; WONDERFUL study group in Japan
Affiliations
Multicenter Study

Quadrant, necrosis, and infection criteria for the risk stratification of walled-off necrosis: external validation using multi-institutional data

Hideyuki Shiomi et al. Gastrointest Endosc. 2025 Jul.

Abstract

Background and aims: EUS-guided peripancreatic fluid drainage (EUS-PFD) with on-demand endoscopic necrosectomy, increasingly used to manage walled-off necrosis (WON), is associated with substantial morbidity and mortality. This multicenter study aimed to externally validate recently developed quadrant (an abdominal quadrant distribution), necrosis, and infection (QNI) criteria for risk stratification in this setting.

Methods: Of 423 patients with pancreatic fluid collections treated in a large multi-institutional cohort between 2010 and 2020, a total of 212 with available preprocedural CT images were included. Clinical outcomes between high- and low-risk groups defined according to QNI criteria were compared.

Results: The clinical success rate did not differ significantly between the QNI-high and QNI-low groups (74.4% vs 83.5%, respectively; P = .12). Time to clinical success was longer in the QNI-high group compared with the QNI-low group (median, 68 vs 46 days; P = .0016). Compared with the QNI-low group, the QNI-high group was associated with higher rates of percutaneous interventions, direct endoscopic necrosectomy, mortality, and adverse events. The QNI-high group was independently associated with time to clinical success (hazard ratio, .64; 95% confidence interval, .46-.87; P = .005) in multivariable Cox proportional hazards regression analysis and with the risk of grade III or higher adverse events (odds ratio, 2.93; 95% confidence interval, 1.04-8.20; P = .04) in multivariable logistic regression analysis.

Conclusions: The QNI criteria effectively stratified time to clinical success and the risk of adverse outcomes for patients receiving EUS-PFD of WON. Further investigations could elucidate appropriate management strategies based on QNI-based risk stratification.

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Conflict of interest statement

Disclosure The following authors disclosed financial relationships: H. Isayama: research funding from Boston Scientific Japan, Fujifilm, and Piolax Medical Devices; honoraria from Boston Scientific Japan, Concept Medical, Create Medic, Fujifilm, Gadelius Medical, Hitachi Medical, Japan Lifeline, Kaneka, Kawasumi Laboratories, Olympus Medical, Piolax Medical Devices, Sumitomo Bakelite, UMIDAS, and Zeon Medical; and contributions from Boston Scientific Japan, Gadelius Medical, Japan Lifeline, and Zeon Medical. Y. Nakai: research funding from Boston Scientific Japan, Century Medical, Fujifilm, Gadelius Medical, HOYA Pentax Medical, Hitachi Medical, Kaneka, and Medico’s Hirata; and honoraria from Boston Scientific Japan, Fujifilm, Gadelius Medical, Hitachi Medical, J-MIT, Medico’s Hirata, and Olympus Medical. All other authors disclosed no financial relationships. This work was supported by a grant from the Japanese Foundation for Research and Promotion of Endoscopy (Research Grant B/#1015, to T.S.) and JSPS KAKENHI (Grants-in-Aid for Scientific Research; grant no. 21K07913, to H.S.). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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