Title: Endoscopic ultrasound versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a randomized trial comparing two management strategies.
Authorolkowski M, Regula J, Tilszer A, Butruk E
Resource: Endoscopy. 2007 Apr;39(4):296-303
Abstract: BACKGROUND AND STUDY AIMS: Diagnostic endoscopic retrograde cholangiography (ERC) is being replaced by endoscopic ultrasonography (EUS) in patients with suspected bile duct stones. The assumption that such an approach is advantageous, however, has never been tested in a randomized trial. PATIENTS AND METHODS: 100 patients with intermediate probability of bile duct stones were randomly allocated to EUS or ERC. Two patients in the ERC group were excluded; the remaining 98 patients received the allocated intervention and were entered into the analysis (EUS, 50 patients; ERC, 48 patients). Detected stones were removed endoscopically; patients without stones were followed for 1 year. The primary end point was the proportion of patients with a negative outcome, related to either endoscopic procedures (complications) or to false-negative diagnosis of stones. Investigators assessing the negative outcomes were not blinded to group assignment. The secondary end point was the total number of endoscopic procedures (EUS and ERC) performed in each group to diagnose and treat stones. RESULTS: Bile duct stone prevalence was 28% and 25% in the EUS and ERC groups, respectively (P > 0.05). In the EUS group, 71 endoscopic procedures were performed, and 63 in the ERC group (mean per patient, 1.42 +/- 0.76, and 1.31 +/- 0.55, respectively; P > 0.05). In the EUS group, these included 49 successful and one failed initial EUS, 15 ERCs for bile duct stone treatment, and six procedures required during follow-up. In the ERC group there were 36 successful and 12 failed initial ERCs, 13 repeat procedures (EUS or ERC) performed after failed or equivocal initial ERC, and two procedures during follow-up. Five patients in the EUS group (10%, 95% CI 4-22) and 19 patients in the ERC group (40%, 95% CI 27-54) experienced a negative outcome (P < 0.001). No difference was observed when only moderate to severe complications were considered (6%, 95% CI 1-17, and 10%, 95% CI 4-23, respectively). CONCLUSIONS: In patients with intermediate probability of bile duct stones, the management strategy based on EUS (with selective ERC in patients with confirmed stones) is safer and not associated with an excess of endoscopic procedures compared with a strategy based on ERC alone.
PMID:17427065
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Title: Endoscopic ultrasound versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a randomized trial comparing two management strategies.
题目：超声内镜与内窥镜逆性胆管造影术诊断中等概率胆管结石患者的一项随机对照研究
Abstract: BACKGROUND AND STUDY AIMS: Diagnostic endoscopic retrograde cholangiography (ERC) is being replaced by endoscopic ultrasonography (EUS) in patients with suspected bile duct stones. The assumption that such an approach is advantageous, however, has never been tested in a randomized trial.
摘要：背景和研究目的：内镜超声检查法(EUS)代替诊断性内窥镜逆性胆管造影术(ERC)检查可疑的胆管结石患者。然而这种认为EUS是更有利的检查方法的假设从来没有被随机试验证实。
PATIENTS AND METHODS: 100 patients with intermediate probability of bile duct stones were randomly allocated to EUS or ERC. Two patients in the ERC group were excluded; the remaining 98 patients received the allocated intervention and were entered into the analysis (EUS, 50 patients; ERC, 48 patients). Detected stones were removed endoscopically; patients without stones were followed for 1 year. The primary end point was the proportion of patients with a negative outcome, related to either endoscopic procedures (complications) or to false-negative diagnosis of stones. Investigators assessing the negative outcomes were not blinded to group assignment. The secondary end point was the total number of endoscopic procedures (EUS and ERC) performed in each group to diagnose and treat stones.
患者和方法：100例中等概率胆管结石患者被随机分配到EUS 或 ERC组。除了ERC组的两个患者之外，其它的98个患者接受分配干涉并进行分析（EUS, 50例患者; ERC, 48例患者）。检查出的结石用内镜取出，没查出结石的患者随访一年。初级终点是与任意一个内镜程序（并发症）或结石的假阴性诊断相关的阴性结果患者的比率。调查者没有盲目的按照分配组评估阴性结果。次级终点是在每组中内镜程序完成诊断和治疗结石患者总数。
RESULTS: Bile duct stone prevalence was 28% and 25% in the EUS and ERC groups, respectively (P > 0.05). In the EUS group, 71 endoscopic procedures were performed, and 63 in the ERC group (mean per patient, 1.42 +/- 0.76, and 1.31 +/- 0.55, respectively; P > 0.05). In the EUS group, these included 49 successful and one failed initial EUS, 15 ERCs for bile duct stone treatment, and six procedures required during follow-up. In the ERC group there were 36 successful and 12 failed initial ERCs, 13 repeat procedures (EUS or ERC) performed after failed or equivocal initial ERC, and two procedures during follow-up. Five patients in the EUS group (10%, 95% CI 4-22) and 19 patients in the ERC group (40%, 95% CI 27-54) experienced a negative outcome (P < 0.001). No difference was observed when only moderate to severe complications were considered (6%, 95% CI 1-17, and 10%, 95% CI 4-23, respectively).
结果：在 EUS and ERC组中胆管结石患病率分别是28% 和 25% (P > 0.05)。在EUS组中，初次行EUS有49个成功病例和1个失败病例，其中15例有胆管结石的患者行ERCs治疗。在ERC组中，初次行ERC有36个成功病例和12个失败病例，13例在初次行ERC失败或可疑时反复进行操作(EUS 或ERC)，两例在随访时进行操作。在EUS组和ERC组中分别有5例患者(10%, 95% CI 4-22)和19例患者(40%, 95% CI 27-54)检测阴性 (P < 0.001)。仅仅考虑严重并发症时，EUS组和ERC组没有差异，分别是6%, 95% CI 1-17, 和 10%, 95% CI 4-23。
CONCLUSIONS: In patients with intermediate probability of bile duct stones, the management strategy based on EUS (with selective ERC in patients with confirmed stones) is safer and not associated with an excess of endoscopic procedures compared with a strategy based on ERC alone.
结论：在中等概率胆管结石患者中，基于EUS（证实有结石的患者选择ERC）的治疗策略与单独基于ERC的治疗策略相比是安全地并且不会存在内镜程序的过度应用。
编译：超声内镜与内窥镜逆性胆管造影术诊断中等概率胆管结石患者的一项随机对照研究
内镜超声检查法(EUS)代替诊断性内窥镜逆性胆管造影术(ERC)检查可疑的胆管结石患者。然而这种认为EUS是更有利的检查方法的假设从来没有被随机试验证实。100例中等概率胆管结石患者被随机分配到EUS 或 ERC组。除了ERC组的两个患者之外，其它的98个患者接受分配干涉并进行分析（EUS, 50例患者; ERC, 48例患者）。检查出的结石用内镜取出，没查出结石的患者随访一年。初级终点是与任意一个内镜程序（并发症）或结石的假阴性诊断相关的阴性结果患者的比率。调查者没有盲目的按照分配组评估阴性结果。次级终点是在每组中内镜程序完成诊断和治疗结石患者总数。在 EUS and ERC组中胆管结石患病率分别是28% 和 25% (P > 0.05)。在EUS组中，初次行EUS有49个成功病例和1个失败病例，其中15例有胆管结石的患者行ERCs治疗。在ERC组中，初次行ERC有36个成功病例和12个失败病例，13例在初次行ERC失败或可疑时反复进行操作(EUS 或ERC)，两例在随访时进行操作。在EUS组和ERC组中分别有5例患者(10%, 95% CI 4-22)和19例患者(40%, 95% CI 27-54)检测阴性 (P < 0.001)。仅仅考虑严重并发症时，EUS组和ERC组没有差异，分别是6%, 95% CI 1-17, 和 10%, 95% CI 4-23。在中等概率胆管结石患者中，基于EUS（证实有结石的患者选择ERC）的治疗策略与单独基于ERC的治疗策略相比是安全地并且不会存在内镜程序的过度应用。
