Cuschieri A, Croce E, Faggioni A, Jakimowicz J, Lacy A, Lezoche E, Morino M, Ribeiro V M, Toouli J, Visa J, Wayand W
Department of Surgery, Ninewells Hospital, University of Dundee, Dundee Tayside DD1 9SY, Scotland.
Surg Endosc. 1996 Dec;10(12):1130-5. doi: 10.1007/s004649900264.
The current management of patients with ductal calculi and gallstone disease consists of endoscopic stone extraction (ESE) followed by laparoscopic cholecystectomy (LC). The advent of techniques of laparoscopic ductal stone clearance has introduced an alternative single stage laparoscopic treatment for these patients. The EAES ductal stone trial was set up to compare the relative efficacy and outcome of these two management options.
The study consists of a prospective randomized controlled clinical trial comparing two management options of patients undergoing LC and suspected of harbouring common duct stones. Patients registered into the trial are randomized to one of two arms: (i) Group A-preoperative ERC with ESE followed by LC during the same hospital admission. (ii) Group B-single stage laparoscopic management consisting of LC and laparoscopic stone extraction either by the trans-cystic duct route or by direct supraduodenal common duct exploration.
This preliminary analysis was carried out on 207 randomized patients with comparisons being made on the intention to treat principle. The two groups (A = 106, B = 101) were comparable with respect to clinical features. ASA grade, serum biochemistry and ultrasound findings.
These preliminary findings indicate equivalent success rates and patient morbidity between the two management options but a shorter hospital stay (cost benefit) with the single stage laparoscopic treatment. Trans-cystic duct extraction is a more benign procedure than laparoscopic supraduodenal CBD exploration and is accompanied by a significantly shorter hospital stay. The higher incidence of conversion in the single stage laparoscopic group compared to the two-stage arm is due to the preference for open common duct exploration when the laparoscopic attempt failed by the majority of participating surgeons. The results to-date suggest that in fit patients, single stage laparoscopic treatment is the better option and the role of ESE should change to selective use in those patients in whom laparoscopic ductal stone extraction has failed.
目前对于胆管结石和胆结石疾病患者的治疗方法是先进行内镜下取石（ESE），然后进行腹腔镜胆囊切除术（LC）。腹腔镜胆管结石清除技术的出现为这些患者提供了一种替代的单阶段腹腔镜治疗方案。EAES胆管结石试验旨在比较这两种治疗方案的相对疗效和结果。
该研究为一项前瞻性随机对照临床试验，比较接受LC且怀疑有胆总管结石的患者的两种治疗方案。纳入试验的患者被随机分为两组：（i）A组——术前进行内镜逆行胰胆管造影（ERC）及ESE，然后在同一住院期间进行LC。（ii）B组——单阶段腹腔镜治疗，包括LC以及通过经胆囊管途径或直接在十二指肠上方胆总管探查进行腹腔镜取石。
对207例随机分组患者进行了初步分析，并按照意向性分析原则进行比较。两组（A组 = 106例，B组 = 101例）在临床特征、美国麻醉医师协会（ASA）分级、血清生化指标及超声检查结果方面具有可比性。
这些初步研究结果表明，两种治疗方案的成功率和患者发病率相当，但单阶段腹腔镜治疗的住院时间更短（具有成本效益）。经胆囊管取石比腹腔镜十二指肠上方胆总管探查的操作更温和，且住院时间明显更短。与两阶段治疗组相比，单阶段腹腔镜组中转开腹手术的发生率更高，这是因为大多数参与研究的外科医生在腹腔镜手术尝试失败时更倾向于进行开放胆总管探查。迄今为止的结果表明，对于身体状况良好的患者，单阶段腹腔镜治疗是更好的选择，而ESE的作用应转变为选择性用于腹腔镜胆管取石失败的患者。
