Lee Tae Hoon, Hwang Soon Oh, Choi Hyun Jong, Jung Yunho, Cha Sang Woo, Chung Il-Kwun, Moon Jong Ho, Cho Young Deok, Park Sang-Heum, Kim Sun-Joo
Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, 23-20 Bongmyung-dong, Cheonan, South Korea.
BMC Gastroenterol. 2014 Feb 17;14:30. doi: 10.1186/1471-230X-14-30.
Numerous clinical trials to improve the success rate of biliary access in difficult biliary cannulation (DBC) during ERCP have been reported. However, standard guidelines or sequential protocol analysis according to different methods are limited in place. We planned to investigate a sequential protocol to facilitate selective biliary access for DBC during ERCP.
This prospective clinical study enrolled 711 patients with naïve papillae at a tertiary referral center. If wire-guided cannulation was deemed to have failed due to the DBC criteria, then according to the cannulation algorithm early precut fistulotomy (EPF; cannulation time > 5 min, papillary contacts > 5 times, or hook-nose-shaped papilla), double-guidewire cannulation (DGC; unintentional pancreatic duct cannulation ≥ 3 times), and precut after placement of a pancreatic stent (PPS; if DGC was difficult or failed) were performed sequentially. The main outcome measurements were the technical success, procedure outcomes, and complications.
Initially, a total of 140 (19.7%) patients with DBC underwent EPF (n = 71) and DGC (n = 69). Then, in DGC group 36 patients switched to PPS due to difficulty criteria. The successful biliary cannulation rate was 97.1% (136/140; 94.4% [67/71] with EPF, 47.8% [33/69] with DGC, and 100% [36/36] with PPS; P < 0.001). The mean successful cannulation time (standard deviation) was 559.4 (412.8) seconds in EPF, 314.8 (65.2) seconds in DGC, and 706.0 (469.4) seconds in PPS (P < 0.05). The DGC group had a relatively low successful cannulation rate (47.8%) but had a shorter cannulation time compared to the other groups due to early switching to the PPS method in difficult or failed DGC. Post-ERCP pancreatitis developed in 14 (10%) patients (9 mild, 1 moderate), which did not differ significantly among the groups (P = 0.870) or compared with the conventional group (P = 0.125).
Based on the sequential protocol analysis, EPF, DGC, and PPS may be safe and feasible for DBC. The use of EPF in selected DBC criteria, DGC in unintentional pancreatic duct cannulations, and PPS in failed or difficult DGC may facilitate successful biliary cannulation.
已有多项关于提高内镜逆行胰胆管造影术（ERCP）中困难胆管插管（DBC）时胆管通路成功率的临床试验报道。然而，针对不同方法的标准指南或序贯方案分析尚不完善。我们计划研究一种序贯方案，以促进ERCP中DBC的选择性胆管通路建立。
这项前瞻性临床研究纳入了一家三级转诊中心的711例初诊乳头患者。如果根据DBC标准判定导丝引导插管失败，则按照插管算法依次进行早期预切开瘘管切开术（EPF；插管时间>5分钟、乳头接触>5次或钩鼻状乳头）、双导丝插管（DGC；意外胰管插管≥3次）以及放置胰管支架后预切开术（PPS；如果DGC困难或失败）。主要观察指标为技术成功率、手术结果及并发症。
最初，共有140例（19.7%）DBC患者接受了EPF（n = 71）和DGC（n = 69）。然后，在DGC组中，36例患者因困难标准转而接受PPS。胆管插管成功率为97.1%（136/140；EPF组为94.4%[67/71]，DGC组为47.8%[33/69]，PPS组为100%[36/36]；P < 0.001）。EPF组的平均成功插管时间（标准差）为559.4（412.8）秒，DGC组为314.8（65.2）秒，PPS组为706.0（469.4）秒（P < 0.05）。DGC组的插管成功率相对较低（47.8%），但由于在困难或失败的DGC中早期转而采用PPS方法，其插管时间比其他组短。14例（10%）患者发生了ERCP后胰腺炎（9例轻度，1例中度），各组之间无显著差异（P = 0.870），与传统组相比也无显著差异（P = 0.125）。
基于序贯方案分析，EPF、DGC和PPS对于DBC可能是安全可行的。在选定的DBC标准中使用EPF，在意外胰管插管中使用DGC，在失败或困难的DGC中使用PPS，可能有助于成功进行胆管插管。
