Endoscopic Ultrasound-Guided Choledochoduodenostomy vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction to Prevent Postprocedural Pancreatitis: A Randomized Trial.

Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent is emerging as a promising approach for managing malignant distal biliary obstruction, offering the potential to lower the risk of postprocedural pancreatitis.

使用腔内对合金属支架的内镜超声引导下胆管十二指肠吻合术（EUS-CDS）作为一种管理恶性远端胆道梗阻的有前景的方法正在出现，它有潜力降低术后胰腺炎的风险。

Methods

This was a multicenter randomized study, enrolling consecutive patients admitted for obstructive jaundice due to malignant distal biliary obstruction with dilated common bile duct (≥15 mm).

这是一项多中心随机研究，招募了因恶性远端胆道阻塞导致梗阻性黄疸而入院的连续患者，这些患者的共同胆管扩张（≥15毫米）。

Patients were randomly allocated to receive EUS-CDS or ERCP for primary biliary drainage.

患者被随机分配接受内镜超声引导下胆管引流术（EUS-CDS）或内镜逆行胰胆管造影术（ERCP）作为主要的胆道引流方法。

This was a superiority trial with postprocedural acute pancreatitis as primary outcome.

这是一项优势试验，以术后急性胰腺炎作为主要结果。

Other outcomes included technical success, clinical success, AEs, 6-month stent patency rate, and overall survival. Analyses were performed according to intention-to-treatprinciples.

其他结果包括技术成功、临床成功、不良事件、6个月支架通畅率和总生存。

Results

Between April 2021 and October 2023, 220 patients were enrolled in the study (EUS-CDS, 111; ERCP, 109).

2021年4月至2023年10月期间，共有220名患者参与了这项研究（EUS-CDS组111人；ERCP组109人）。

EUS-CDS group showed a lower risk for postprocedural acute pancreatitis (1.8% in EUS-CDS vs 7.3% in ERCP; relative risk, 0.25; 95% confidence interval, 0.07-0.88).

EUS-CDS组显示了较低的术后急性胰腺炎风险（EUS-CDS组为1.8%，ERCP组为7.3%；相对风险为0.25；95%置信区间为0.07-0.88）。

Technical success was achieved in 94.6% in EUS-CDS group vs 78.9% ERCP group (P < .001), in a mean procedural time of 13.5 ± 11.6 minutes and 24.7 ± 14.9 minutes, respectively (P <.001).

EUS-CDS组的技术成功率为94.6%，而ERCP组为78.9%（P < .001），平均手术时间为13.5 ± 11.6分钟和24.7 ± 14.9分钟，分别（P <.001）。

No differences were found in other AEs (19.8% in EUS-CDS vs 21.1% in ERCP; relative risk, 0.94; 95% confidence interval, 0.56-1.58), clinical success, stent patency, or overall mortality.

在其他不良事件（EUS-CDS组为19.8%，ERCP组为21.1%；相对风险为0.94；95%置信区间为0.56-1.58）、临床成功率、支架通畅性或总死亡率方面未发现差异。

Conclusions

EUS-CDS is superior to ERCP in reducing postprocedural acute pancreatitis risk.

内镜超声引导下胆管引流（EUS-CDS）在降低术后急性胰腺炎风险方面优于内镜逆行胰胆管造影术（ERCP）。

However, the overall risk of AEs was not significantly different and warrants further investigation.

然而，不良事件（AEs）的总体风险并没有显著差异，需要进一步研究。

Additionally EUS-CDS showed improved technical success and comparable clinical efficacy.

此外，EUS-CDS显示出更高的技术成功率和相当的临床疗效。

These results support a potential role of EUS-CDS as primary approach in selected patients with dilated common bile duct (ClinicalTrials.gov, Number: NCT04099862).

这些结果支持在选择性患有扩张的胆总管的患者中，将EUS-CDS作为首选方法的潜在作用（ClinicalTrials.gov, 编号: NCT04099862）。