Bergman J J, Rauws E A, Fockens P, van Berkel A M, Bossuyt P M, Tijssen J G, Tytgat G N, Huibregtse K
Department of Gastroenterology, University of Amsterdam, The Netherlands.
Lancet. 1997 Apr 19;349(9059):1124-9. doi: 10.1016/S0140-6736(96)11026-6.
Endoscopic sphincterotomy (EST) for the removal of bileduct stones is associated with acute complications and a permanent loss of biliary-sphincter function. Endoscopic balloon dilation (EBD) causes less trauma to the biliary sphincter, but may be less effective in allowing stone removal.
218 consecutive patients with bileduct stones on endoscopic retrograde cholangiopancreatography (ERCP) were enrolled. 202 who met all eligibility criteria were randomly assigned EST or EBD. The patients were observed in hospital for at least 24 h and followed up at 1 month and 6 months. Complications were classified by an expert panel unaware of treatment allocation and outcome. Analysis was done by intention to treat.
After a single ERCP, all stones were removed from 92 (91%) of 101 patients assigned EST and 90 (89%) of 101 assigned EBD (p = 0.81); in nine of the latter, successful removal required additional EST. Mechanical lithotripsy was used to fragment stones in 31 EBD procedures and 13 EST procedures (p < 0.005). Early complications (before 15 days) occurred in 24 EST patients and 17 EBD patients (p = 0.29). One patient died of retroperitoneal perforation after EBD. Four patients had bleeding after EST. Seven patients in each group had pancreatitis. Complications during follow-up occurred in 23 EST patients and 18 EBD patients (p = 0.48). Acute cholecystitis was observed in seven EST patients and one EBD patient (p < 0.05).
The success rate of EBD was similar to that of EST. We found there is no evidence of the previously suggested higher risk of pancreatitis with EBD and suggest that EBD is preferred in patients at risk of bleeding after EST. Preservation of biliary-sphincter function after EBD may prevent long-term complications and reduce the risk of acute cholecystitis during follow-up. This procedure is a valuable alternative to EST in patients with bileduct stones.
内镜下括约肌切开术（EST）用于清除胆管结石时会伴有急性并发症以及永久性胆管括约肌功能丧失。内镜下球囊扩张术（EBD）对胆管括约肌造成的创伤较小，但在结石清除方面可能效果较差。
纳入218例经内镜逆行胰胆管造影（ERCP）确诊为胆管结石的连续患者。202例符合所有入选标准的患者被随机分配接受EST或EBD治疗。患者在医院观察至少24小时，并在1个月和6个月时进行随访。并发症由一个不知道治疗分配和结果的专家小组进行分类。分析采用意向性分析。
单次ERCP后，接受EST治疗的101例患者中有92例（91%）结石全部清除，接受EBD治疗的101例患者中有90例（89%）结石全部清除（p = 0.81）；后一组中有9例患者需要额外进行EST才能成功清除结石。在31例EBD手术和13例EST手术中使用了机械碎石术来破碎结石（p < 0.005）。早期并发症（15天内）在24例EST患者和17例EBD患者中发生（p = 0.29）。1例患者在EBD后死于腹膜后穿孔。4例患者在EST后出现出血。每组有7例患者发生胰腺炎。随访期间并发症在23例EST患者和18例EBD患者中发生（p = 0.48）。7例EST患者和1例EBD患者观察到急性胆囊炎（p < 0.05）。
EBD的成功率与EST相似。我们发现没有证据表明之前所认为的EBD导致胰腺炎风险更高，并且建议在EST后有出血风险的患者中首选EBD。EBD后保留胆管括约肌功能可能预防长期并发症并降低随访期间急性胆囊炎的风险。该手术是胆管结石患者EST的一种有价值的替代方法。
