Chopra K B, Peters R A, O'Toole P A, Williams S G, Gimson A E, Lombard M G, Westaby D
Gastrointestinal Unit, Chelsea & Westminster Hospital, London, UK.
Lancet. 1996 Sep 21;348(9030):791-3. doi: 10.1016/S0140-6736(96)06316-7.
The value of an endoprosthesis for long-term management of bileduct stones has not been formally established. The main theoretical advantage of endoprosthesis insertion (BE) over conventional endoscopic duct clearance (DC) is the prevention of stone impaction, with obstruction and consequent cholangitis or pancreatitis. In a randomised study we compared the results of these two methods in patients with symptomatic bileduct stones who were at high risk because of old age (> 70 yr) or serious debilitating disease.
43 high-risk patients were randomised to BE with a 7F double-pigtail endoprosthesis and < 0.75 cm sphincterotomy, and 43 to DC with standard 1.25-1.50 cm sphincterotomy and stone extraction by balloon or basket, with or without mechanical lithotripsy. The principal endpoint was the rate of biliary related complications.
In the BE group biliary drainage was achieved in the first session in all but one patient (who required 2 sessions). In the DC group, 24 patients had duct clearance at the first attempt and 35 (81%) after a median of 2 sessions (range 2-4); eight of this group had an endoprosthesis inserted to maintain long-term drainage. At 72 h the complication rates were 7% in the BE group and 16% in the DC group (p = 0.18). However, the long-term complication rate for BE was higher: by Kaplan-Meier analysis, at a median of 20 months the proportions free of biliary complications were 64% BE and 86% DC (p = 0.03, log-rank test).
For immediate bileduct drainage, endoprosthesis insertion proved a safe and effective alternative to duct clearance. Because of the risk of subsequent cholangitis, its use as a definitive treatment should be confined to highly selected cases.
胆管结石长期治疗中内置假体的价值尚未得到正式确立。与传统内镜下胆管清理术（DC）相比，插入内置假体（BE）的主要理论优势在于预防结石嵌顿，避免梗阻及随之而来的胆管炎或胰腺炎。在一项随机研究中，我们比较了这两种方法在因高龄（>70岁）或严重衰弱性疾病而处于高风险的有症状胆管结石患者中的治疗结果。
43例高风险患者被随机分为两组，一组接受7F双猪尾内置假体及<0.75 cm括约肌切开术的BE治疗，另一组接受标准1.25 - 1.50 cm括约肌切开术及通过球囊或网篮进行结石取出（可联合或不联合机械碎石术）的DC治疗。主要终点是胆管相关并发症的发生率。
在BE组中，除1例患者（需要2次手术）外，所有患者在首次手术时均实现了胆汁引流。在DC组中，24例患者首次尝试即实现了胆管清理，35例（81%）患者在中位2次手术（范围2 - 4次）后实现清理；该组中有8例患者插入了内置假体以维持长期引流。在72小时时，BE组的并发症发生率为7%，DC组为16%（p = 0.18）。然而，BE的长期并发症发生率更高：通过Kaplan - Meier分析，在中位20个月时，无胆管并发症的比例在BE组为64%，在DC组为86%（p = 0.03，对数秩检验）。
对于立即进行胆管引流，插入内置假体被证明是一种安全有效的替代胆管清理的方法。由于后续有发生胆管炎的风险，其作为确定性治疗的应用应仅限于经过严格筛选的病例。
