Immediate or On-Demand Endoscopic Necrosectomy for Necrotizing Pancreatitis: A Randomized Controlled Trial (WONDER-01).

We hypothesized that immediate DEN after EUS-guided drainage might reduce the time to disease resolution compared with a drainage-oriented step-up approach.

我们假设，在内镜超声引导下引流后立即进行DEN可能会缩短疾病缓解时间，与以引流为导向的逐步治疗法相比。

Methods

This study was a multicenter, open-label, superiority randomized trial (WONDER-01).

本研究是一项多中心、开放标签、优效性随机试验（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.

在接受内镜超声引导治疗的有症状坏死性胰腺炎患者中，符合入选条件的患者按1:1的比例随机分配，接受立即去神经化（DEN）治疗或引流导向的逐步治疗方案。

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.

主要终点是从随机化到临床成功的时长，定义为收集大小减少到≤3厘米以及炎症标志物的改善。

Results

Seventy patients were enrolled in this study: 33 in the immediate DEN arm and 37 in the step-up arm.

本研究共纳入了70名患者：其中33名患者在立即去氨加压素（DEN）组，37名患者在逐步加压组。

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.

立即使用DEN与逐步方法相比，临床成功所需时间更短（P = .009），中位时间（95%置信区间）分别为29（19-34）天和44（38-52）天。

All patients in the immediate DEN arm received DEN compared with 46% in the step-up approach arm, but the rates of procedure-related adverse events were comparable (24% vs 22%, respectively; P = .79).

立即DEN组的所有患者都接受了DEN治疗，而在逐步方法组中只有46%的患者接受了DEN治疗，但两组的与程序相关的不良事件发生率相当（分别为24%和22%；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).

在技术成功（100%对比97%；P>0.99）和死亡率（12%对比5.4%；P=0.41）方面，治疗组之间没有显著差异。

Conclusions

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

与逐步方法相比，内镜下坏死组织清除术（DEN）在内镜超声（EUS）引导下对坏死性胰腺炎进行引流后立即进行，缩短了达到临床成功的所需时间，且没有增加不良事件，但需要更多的DEN操作（ClinicalTrials.gov, NCT05451901）。