Division of Gastroenterology and Gastrointestinal Endoscopy, Università Vita-Salute San Raffaele, IRCCS San Raffaele Hospital, Milan, Italy.
Am J Gastroenterol. 2010 Aug;105(8):1753-61. doi: 10.1038/ajg.2010.136. Epub 2010 Apr 6.
Prospective studies have identified a number of patient- and procedure-related independent risk factors for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, with different conclusions, so various questions are still open. The endoscopist's expertise, case volume, and case mix can all significantly influence the outcome of ERCP procedures, but have been investigated little to date.
We identified patient- and procedure-related risk factors for post-ERCP pancreatitis and the impact of the endoscopist's experience and the center's case volume, using univariate and multivariate analysis, in a multicenter, prospective study involving low- and high-volume centers, over a 6-month period.
A total of 3,635 ERCP procedures were included; 2,838 (78%) ERCPs were performed in the 11 high-volume centers (median 257 each) and 797 in the 10 low-volume centers (median 45 each). Overall, 3,331 ERCPs were carried out by expert operators and 304 by less-skilled operators. There were significantly more grade 3 difficulty procedures in high-volume centers than in low-volume ones (P<0.0001). Post-ERCP pancreatitis occurred in 137 patients (3.8%); the rates did not differ between high- and low-volume centers (3.9% vs. 3.1%) and expert and non-expert operators (3.8% vs. 5.5%). However, in high-volume centers, there were 25% more patients with patient- and procedure-related risk factors, and the pancreatitis rate was one-third higher among non-expert operators. Univariate analysis found a significant association with pancreatitis for history of acute pancreatitis, either non-ERCP- or ERCP-related and recurrent, young age, absence of bile duct stones, and biliary pain among patient-related risk factors, and >10 attempts to cannulate the Vater's papilla, pancreatic duct cannulation, contrast injection of the pancreatic ductal system, pre-cut technique, and pancreatic sphincterotomy, among procedure-related risk factors. Multivariate analysis also showed that a history of post-ERCP pancreatitis, biliary pain, >10 attempts to cannulate the Vater's papilla, main pancreatic duct cannulation, and pre-cut technique were significantly associated with the complication.
A history of pancreatitis among patient-related factors, and multiple attempts at cannulation among procedure-related factors, were associated with the highest rates of post-ERCP pancreatitis. Pre-cut sphincterotomy, although identified as another significant risk factor, appeared safer when done early (fewer than 10 attempts at cannulating), compared with repeated multiple cannulation. The risk of post-ERCP pancreatitis was not associated with the case volume of either the single endoscopist or the center; however, high-volume centers treated a larger proportion of patients at high risk of pancreatitis and did a significantly greater number of difficult procedures.
已有多项前瞻性研究确定了一些与内镜逆行胰胆管造影术(ERCP)后胰腺炎相关的患者和操作相关的独立危险因素,但存在不同结论,因此仍有许多问题尚未解决。内镜医生的专业知识、操作数量和操作难度等都可能显著影响 ERCP 操作的结果,但目前对这些因素的研究较少。
我们通过单因素和多因素分析,在一项涉及低容量和高容量中心的为期 6 个月的多中心前瞻性研究中,确定了与 ERCP 后胰腺炎相关的患者和操作相关的危险因素,以及内镜医生经验和中心操作数量的影响。
共纳入 3635 例 ERCP 操作;2838 例(78%)在 11 个高容量中心(中位操作数量为 257 例)进行,797 例在 10 个低容量中心(中位操作数量为 45 例)进行。总体而言,3331 例 ERCP 由专家操作,304 例由经验较少的医生操作。高容量中心中难度等级为 3 级的操作明显多于低容量中心(P<0.0001)。137 例(3.8%)患者发生 ERCP 后胰腺炎;高容量中心和低容量中心的发生率(3.9% vs. 3.1%)和专家和非专家操作的发生率(3.8% vs. 5.5%)无差异。然而,在高容量中心,有 25%的患者具有患者和操作相关的危险因素,而非专家操作的胰腺炎发生率要高三分之一。单因素分析发现,与胰腺炎相关的因素包括急性胰腺炎病史(非 ERCP 或 ERCP 相关且反复发作)、年轻、无胆管结石和胆绞痛,患者相关危险因素;以及>10 次尝试乳头插管、胰管插管、胰管系统造影剂注射、预切开技术和胰管括约肌切开术,操作相关危险因素。多因素分析还表明,胰腺炎病史、胆绞痛、>10 次尝试乳头插管、主胰管插管和预切开技术与并发症显著相关。
患者相关因素中胰腺炎病史,以及操作相关因素中多次插管尝试,与 ERCP 后胰腺炎的发生率最高相关。尽管预切开括约肌切开术被确定为另一个显著的危险因素,但与多次重复插管相比,早期(<10 次插管尝试)进行时似乎更安全。内镜医生或中心的操作量与 ERCP 后胰腺炎的风险无关;然而,高容量中心治疗了更多处于胰腺炎高风险的患者,并且进行了更多难度较大的操作。