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内镜下塑料支架置入治疗胆管结石:按需更换支架或每 3 个月更换一次。一项前瞻性对比研究。

Endoscopic plastic stenting for bile duct stones: stent changing on demand or every 3 months. A prospective comparison study.

机构信息

Department of Gastroenterology, Loreto Mare Hospital, Naples, Italy.

出版信息

Endoscopy. 2013 Dec;45(12):1014-7. doi: 10.1055/s-0033-1344556. Epub 2013 Nov 28.

DOI:10.1055/s-0033-1344556
PMID:24288221
Abstract

BACKGROUND AND STUDY AIMS

Endoscopic biliary sphincterotomy and stone removal is the standard of care for choledocholithiasis, with a success rate of > 90%. For stones ≤ 25 mm diameter, mechanical lithotripsy, extracorporeal shock wave lithotripsy, electrohydraulic lithotripsy, and laser lithotripsy can be used. In the case of failure, the next step is surgery. In elderly patients and in patients with an elevated surgical risk, stenting is the only treatment modality. In these cases the aim is to avoid the onset of acute obstructive cholangitis. The aim of the current study was to evaluate the best management of plastic stents in patients with biliary duct stones who were unfit for surgery and in whom previous endoscopic therapy had failed.

METHODS

Patients who were high surgical risks and in whom stone clearance was not possible due to the number and sizes of stones were included. Between March 2008 and September 2010 all patients were treated with endoscopic plastic biliary stenting at four tertiary care referral centers in Italy. Patients were randomly assigned to two groups: in Group A (n=39) plastic stents were changed every 3 months or sooner if symptoms appeared; in Group B plastic stents were changed on demand at the onset of symptoms, and ultrasonography and blood samples were performed every 3 months to check for signs of cholestasis and inflammation. The primary outcome was the rate of cholangitis. The secondary outcome was the rate of stone clearance after a period of stenting.

RESULTS

A total of 78 patients were included in the study (43 M/35F; mean age 76 years). Acute cholangitis occurred in 3 patients from Group A and in 14 patients from Group B (P=0.03). Mortality related to cholangitis occurred in one patient from Group A and three patients from Group B (P=n.s.). The mean follow-up was 13.5 months (range 2-23). Stone clearance after long term stenting occurred in 24 patients from Group A (61.5 %) and in 21 patients from group B (53.8%) (P=n.s.).

CONCLUSIONS

In patients with bile duct stones who were treated with biliary plastic stents, the best stent management to avoid cholangitis was stent changing at defined intervals (every 3 months in the current study). The data confirmed that plastic biliary stenting may decrease stone size with a high percentage of subsequent total stone clearance.

摘要

背景与研究目的

内镜下胆管括约肌切开术和取石术是治疗胆总管结石的标准方法,成功率>90%。对于直径≤25mm 的结石,可以使用机械碎石、体外冲击波碎石、液电碎石和激光碎石。如果治疗失败,下一步就是手术。对于老年患者和手术风险较高的患者,支架置入术是唯一的治疗方法。在这些情况下,目的是避免急性梗阻性胆管炎的发生。本研究的目的是评估在不适合手术且内镜治疗失败的胆管结石患者中,塑料支架的最佳管理方法。

方法

纳入因结石数量和大小无法清除结石且手术风险较高的患者。2008 年 3 月至 2010 年 9 月,意大利四家三级转诊中心的所有患者均采用内镜下塑料胆道支架治疗。患者随机分为两组:A 组(n=39),支架每 3 个月更换一次,或出现症状时更早更换;B 组(n=39),症状出现时按需更换支架,并每 3 个月进行超声和血液检查,以检查胆汁淤积和炎症迹象。主要结局是胆管炎的发生率。次要结局是支架置入后结石清除率。

结果

共纳入 78 例患者(43 例男性/35 例女性;平均年龄 76 岁)。A 组有 3 例患者发生急性胆管炎,B 组有 14 例患者发生急性胆管炎(P=0.03)。A 组有 1 例患者和 B 组有 3 例患者因胆管炎死亡(P=n.s.)。平均随访时间为 13.5 个月(2-23 个月)。A 组 24 例(61.5%)和 B 组 21 例(53.8%)患者长期支架置入后结石清除(P=n.s.)。

结论

在接受胆道塑料支架治疗的胆管结石患者中,避免胆管炎的最佳支架管理方法是定期更换支架(本研究中每 3 个月更换一次)。数据证实,塑料胆道支架可以缩小结石的大小,并使随后的总结石清除率达到较高水平。

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