Tse Frances, Yuan Yuhong, Moayyedi Paul, Leontiadis Grigorios I
Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Canada.
Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD009662. doi: 10.1002/14651858.CD009662.pub2.
Cannulation techniques have been recognized to be important in causing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, considerable controversy exists about the usefulness of the guidewire-assisted cannulation technique for the prevention of PEP.
To systematically review evidence from randomised controlled trials (RCTs) assessing the effectiveness and safety of the guidewire-assisted cannulation technique compared to the conventional contrast-assisted cannulation technique for the prevention of PEP.
We searched CENTRAL (The Cochrane Library), MEDLINE, EMBASE, and CINAHL databases and major conference proceedings, up to February 2012, using the Cochrane Upper Gastrointestinal and Pancreatic Diseases model with no language restrictions.
RCTs comparing the guidewire-assisted cannulation technique versus the contrast-assisted cannulation technique in patients undergoing ERCP.
Two review authors conducted study selection, data extraction and methodological quality assessment independently. Using intention-to-treat analysis with random-effects models, we combined dichotomous data to obtain risk ratios (RR) with 95% confidence intervals (CI). We assessed heterogeneity using the Chi² test (P < 0.15) and I² statistic (> 25%). To explore sources of heterogeneity, we conducted a priori subgroup analyses according to trial design, publication type, risk of bias, use of precut sphincterotomy, inadvertent guidewire insertion or contrast injection of the pancreatic duct (PD), use of a PD stent, cannulation device, and trainee involvement in cannulation. To assess the robustness of our results we carried out sensitivity analyses using different summary statistics (RR versus odds ratio (OR)) and meta-analytic models (fixed-effect versus random-effects), and per protocol analysis.
Twelve RCTs comprising 3450 participants were included. There was statistical heterogeneity among trials for the outcome of PEP (P = 0.04, I² = 45%). The guidewire-assisted cannulation technique significantly reduced PEP compared to the contrast-assisted cannulation technique (RR 0.51, 95% CI 0.32 to 0.82). In addition, the guidewire-assisted cannulation technique was associated with greater primary cannulation success (RR 1.07, 95% CI 1.00 to 1.15), less precut sphincterotomy (RR 0.75, 95% CI 0.60 to 0.95), and no increase in other ERCP-related complications. Subgroup analyses indicated that this significant risk reduction in PEP with the guidewire-assisted cannulation technique existed only in 'non-crossover' trials (RR 0.22, 95% CI 0.12 to 0.42). The results were robust in sensitivity analyses.
AUTHORS' CONCLUSIONS: Compared with the contrast-assisted cannulation technique, the guidewire-assisted cannulation technique increases the primary cannulation rate and reduces the risk of PEP, and it appears to be the most appropriate first-line cannulation technique.
插管技术被认为是导致内镜逆行胰胆管造影术（ERCP）后胰腺炎（PEP）的重要因素。然而，关于导丝辅助插管技术在预防PEP方面的有效性，仍存在相当大的争议。
系统评价随机对照试验（RCT）的证据，评估与传统造影剂辅助插管技术相比，导丝辅助插管技术预防PEP的有效性和安全性。
我们使用Cochrane上消化道和胰腺疾病模型，检索CENTRAL（Cochrane图书馆）、MEDLINE、EMBASE和CINAHL数据库以及主要会议论文集，检索截至2012年2月的数据，且无语言限制。
比较ERCP患者中导丝辅助插管技术与造影剂辅助插管技术的RCT。
两位综述作者独立进行研究选择、数据提取和方法学质量评估。采用意向性分析和随机效应模型，我们合并二分数据以获得风险比（RR）及95%置信区间（CI）。我们使用卡方检验（P<0.15）和I²统计量（>25%）评估异质性。为探究异质性来源，我们根据试验设计、发表类型、偏倚风险、预切开括约肌切开术的使用、意外导丝插入或胰管（PD）造影剂注射、PD支架的使用、插管装置以及实习生参与插管情况进行了预先亚组分析。为评估结果的稳健性，我们使用不同的汇总统计量（RR与比值比（OR））和荟萃分析模型（固定效应与随机效应）进行敏感性分析，并进行符合方案分析。
纳入了12项RCT，共3450名参与者。PEP结局在各试验间存在统计学异质性（P = 0.04，I² = 45%）。与造影剂辅助插管技术相比，导丝辅助插管技术显著降低了PEP（RR 0.51，95% CI 0.32至0.82）。此外，导丝辅助插管技术与更高的首次插管成功率（RR 1.07，95% CI 1.00至1.15）、更少的预切开括约肌切开术（RR 0.75，95% CI 0.60至0.95）相关，且未增加其他ERCP相关并发症。亚组分析表明，导丝辅助插管技术显著降低PEP风险仅存在于“非交叉”试验中（RR 0.22，95% CI 0.12至0.42）。敏感性分析结果稳健。
与造影剂辅助插管技术相比，导丝辅助插管技术提高了首次插管率，降低了PEP风险，似乎是最合适的一线插管技术。
