Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial.

However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP).

然而，FCSEMS置入与高风险的ERCP后胰腺炎（PEP）相关。

Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk.

在放置FCSEMS之前进行内镜下括约肌切开术可能会降低PEP风险。

To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement.

比较在放置FCSEMS之前进行内镜下括约肌切开术与不进行括约肌切开术的效果。

Methods

This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO.

这是一项多中心、随机、优效试验，在17家医院进行，纳入了疑似远端恶性胆道梗阻的患者。

Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement.

患者在内镜逆行胰胆管造影（ERCP）期间被随机分配，接受内镜括约肌切开术（括约肌切开组）或不接受括约肌切开术（对照组），然后放置全覆膜自扩张金属支架（FCSEMS）。

The primary outcome was PEP within 30 days.

主要结果是30天内的胰腺炎发作（PEP）。

Secondary outcomes included procedure-related complications and 30-day mortality.

次要结果包括与程序相关的并发症和30天内的死亡率。

An interim analysis was performed after 50% of patients (n=259) had completed follow-up.

在50%的患者（n=259）完成随访后，进行了中期分析。

Results

Between May 2016 and June 2023, 297 patients were included in the intention-to-treatanalysis, with 156 in the sphincterotomy group and 141 in the control group.

在2016年5月至2023年6月期间，共有297名患者纳入意向治疗分析，其中156名患者在括约肌切开术组，141名患者在对照组。

After the interim analysis, the study was terminated prematurely due to futility.

在中期分析后，由于无效性，研究被提前终止。

PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37).

两组间PEP的发生率没有差异，括约肌切开组有26名患者（17%）出现PEP，对照组有30名患者（21%）出现PEP（相对风险0.78，95%置信区间0.49至1.26，p=0.37）。

There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality.

在出血、穿孔、胆管炎、胆囊炎或30天死亡率方面没有显著差异。

Conclusions

This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO.

该试验发现，在降低远端恶性胆道梗阻患者的PEP方面，内镜括约肌切开术并不优于不进行括约肌切开术。

Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement.

因此，目前尚无足够证据推荐在FCEMS置入前常规进行内镜括约肌切开术。

trial_registration_number

NL5130.

NL5130.