Karakan Tarkan, Cindoruk Mehmet, Alagozlu Hakan, Ergun Meltem, Dumlu Sukru, Unal Selahattin
Department of Gastroenterology, Faculty of Medicine, Gazi University, Ankara, Turkey.
Gastrointest Endosc. 2009 Feb;69(2):244-52. doi: 10.1016/j.gie.2008.05.023. Epub 2008 Nov 18.
Factors affecting diagnostic accuracy and comparison of patients in the follow-up period for negative outcomes are not thoroughly investigated in a randomized trial.
Our purpose was to compare diagnostic accuracy, complications, and number of interventions.
Prospective, unicentric, single-blind, randomized study.
Single tertiary referral university hospital.
One hundred twenty patients with intermediate risk for common bile duct (CBD) stones were randomized to either an EUS-first, endoscopic retrograde cholangiography (ERC)-second (n = 60) versus an ERC-only (n = 60) procedure.
EUS, ERC, sphincterotomy, and balloon sweeping of CBD when needed.
Sensitivity of EUS versus ERC, factors affecting diagnostic capability, complications, total number of endoscopic procedures.
The sensitivity and specificity of ERC were 75% (95% CI, 42%-93%) and 100% (95% CI, 95%-100%), respectively. The sensitivity and specificity of EUS were 91% (95% CI, 59%-99%) and 100% (95% CI, 95%-100%), respectively. EUS is more sensitive than ERC in detecting stones smaller than 4 mm (90% vs 23%, P < .01). Although not significant, there was a trend for an increased number of endoscopic procedures in the ERC group compared with the EUS group (98 vs 83). The post-ERC pancreatitis rate was 6 in 120 (5%) in all study patients, and the post-ERC pancreatitis rate in patients with an undilated CBD was 5 of 53 (9.43%). The independent factors for post-ERC pancreatitis are undilated CBD (risk ratio [RR] 6.320; 95% CI, 1.703-11.524, P = .009), allocation into the ERC group (RR 2.107; 95% CI, 1.330-3.339, P = .02), female sex (RR 1.803; 95% CI, 1.155-2.813, P = .03), and age less than 40 years (RR 1.888; 95% CI, 1.245-2.863, P = .01). Kaplan-Meier analysis revealed higher rate of negative outcome in the ERC group than in the EUS group (P = .049, log-rank test).
The EUS-first approach is not associated with further risk for subsequent endoscopic procedures. Patients with an undilated CBD should be investigated by the EUS-first approach to prevent post-ERC pancreatitis.
在一项随机试验中，尚未对影响诊断准确性的因素以及随访期内出现阴性结果的患者进行全面研究。
我们的目的是比较诊断准确性、并发症和干预次数。
前瞻性、单中心、单盲、随机研究。
单一的三级转诊大学医院。
120例胆总管（CBD）结石中度风险患者被随机分为先进行超声内镜检查（EUS）、后进行内镜逆行胆管造影（ERC）组（n = 60）和仅进行ERC组（n = 60）。
EUS、ERC、括约肌切开术，并在需要时对CBD进行球囊清扫。
EUS与ERC的敏感性、影响诊断能力的因素、并发症、内镜检查的总数。
ERC的敏感性和特异性分别为75%（95%CI，42%-93%）和100%（95%CI，95%-100%）。EUS的敏感性和特异性分别为91%（95%CI，59%-99%）和100%（95%CI，95%-100%）。EUS在检测小于4mm的结石方面比ERC更敏感（90%对23%，P <.01）。虽然差异不显著，但与EUS组相比，ERC组的内镜检查次数有增加的趋势（98次对83次）。在所有研究患者中，ERC后胰腺炎的发生率为120例中的6例（5%），在CBD未扩张的患者中，ERC后胰腺炎的发生率为53例中的5例（9.43%）。ERC后胰腺炎的独立危险因素是CBD未扩张（风险比[RR]6.320；95%CI, 1.703 - 11.524, P =.009）、被分配到ERC组（RR 2.107；95%CI, 1.330 - 3.339, P =.02）、女性（RR 1.803；95%CI, 1.155 - 2.813, P =.03）和年龄小于40岁（RR 1.888；95%CI, 1.245 - 2.863, P =.01）。Kaplan-Meier分析显示，ERC组的阴性结果发生率高于EUS组（P =.049，对数秩检验）。
先进行EUS的方法与后续内镜检查的进一步风险无关。CBD未扩张的患者应采用先进行EUS的方法进行检查，以预防ERC后胰腺炎。
