ドレナージ後早期の壊死物除去が急性膵炎後の被包化膵壊死(WON)の治療期間を短縮する~WONDER-01試験により明らかに~

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2026-02-18 東京大学

東京大学医学部附属病院東京女子医科大学らのWONDERFUL study groupは、急性膵炎後の被包化膵壊死(WON)に対する多施設無作為化比較試験「WONDER-01」を実施し、超音波内視鏡下ドレナージ後に早期内視鏡的ネクロセクトミーを行うことで、偶発症を増やさず治療期間を有意に短縮できることを世界で初めて証明した。70例を早期群(33例)と従来Step-up群(37例)に割付け、壊死物縮小(3cm以下)と炎症改善を評価。早期群はより短期間で臨床的成功を達成し、有害事象発生率は同等だった。致死率約10%の難治疾患に対し、予後改善と標準治療確立に寄与する成果であり、Gastroenterologyに掲載された。

ドレナージ後早期の壊死物除去が急性膵炎後の被包化膵壊死(WON)の治療期間を短縮する~WONDER-01試験により明らかに~
急性膵炎後 WON と WON に対する内視鏡治療

<関連情報>

壊死性膵炎に対する即時またはオンデマンド内視鏡的壊死切除術:ランダム化比較試験(WONDER-01) Immediate or On-Demand Endoscopic Necrosectomy for Necrotizing Pancreatitis: A Randomized Controlled Trial (WONDER-01)

Tomotaka Saito, MD, PhD ∙ Toshio Fujisawa, MD, PhD ∙ Takeshi Ogura, MD, PhD ∙ … ∙ Ichiro Yasuda, MD, PhD ∙ Yousuke Nakai, MD, PhD the WONDERFUL study group in Japan and collaborators
Gastroenterology  Published: February 17, 2026
DOI:https://doi.org/10.1053/j.gastro.2026.01.034

Abstract

BACKGROUND & AIMS

The optimal timing for direct endoscopic necrosectomy (DEN) following endoscopic ultrasound (EUS)-guided transmural drainage of symptomatic necrotizing pancreatitis remains unknown. We hypothesized that immediate DEN following EUS-guided drainage might reduce the time to disease resolution compared with a drainage-oriented step-up approach.

METHODS

This study was a multicenter, open-label, superiority randomized trial (WONDER-01). Among patients who received EUS-guided treatment for symptomatic necrotizing pancreatitis, eligible patients were randomly assigned 1:1 to receive either immediate DEN or the drainage-oriented step-up approach. The primary endpoint was the time from randomization to clinical success, defined as a decrease in collection size to ≤3 cm and an improvement in inflammatory markers.

RESULTS

Seventy patients were enrolled in this study: 33 in the immediate DEN arm and 37 in the step-up arm. Immediate DEN was associated with a shorter time to clinical success than the step-up approach (P = .009), with median times (95% confidence interval) of 29 (19–34) and 44 (38–52) days, respectively. All patients in the immediate DEN arm received DEN compared to 46% in the step-up approach arm, but the rates of procedure-related adverse events were comparable (24% vs 22%, respectively; P = .79). No significant differences were noted between the treatment arms in terms of technical success (100% vs 97%, P > .99) and mortality (12% vs 5.4%, P = .41).

CONCLUSION

Compared with the step-up approach, immediate DEN following EUS-guided drainage of necrotizing pancreatitis reduced time to clinical success without increasing adverse outcomes but required more DEN procedures (ClinicalTrials.gov, Number: NCT05451901).

医療・健康
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