Kylänpää Leena, Koskensalo Vilja, Saarela Arto, Ejstrud Per, Udd Marianne, Lindström Outi, Rainio Mia, Tenca Andrea, Halttunen Jorma, Qvigstad Gunnar, Arnelo Urban, Fagerström Niklas, Hauge Truls, Aabakken Lars, Grönroos Juha
Abdominal Center, Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Department of Gastrointestinal Surgery, Oulu University Hospital, Oulu, Finland.
Endoscopy. 2021 Oct;53(10):1011-1019. doi: 10.1055/a-1327-2025. Epub 2021 Jan 13.
Difficult biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP) increases the risk of post-ERCP pancreatitis (PEP). The purpose of this prospective, randomized, multicenter study was to compare two advanced rescue methods, transpancreatic biliary sphincterotomy (TPBS) and a double-guidewire (DGW) technique, in difficult common bile duct (CBD) cannulation.
Patients with native papilla and planned CBD cannulation were recruited at eight Scandinavian hospitals. An experienced endoscopist attempted CBD cannulation with wire-guided cannulation. If the procedure fulfilled the definition of difficult cannulation and a guidewire entered the pancreatic duct, randomization to either TPBS or to DGW was performed. If the randomized method failed, any method available was performed. The primary end point was the frequency of PEP and the secondary end points included successful cannulation with the randomized method.
In total, 1190 patients were recruited and 203 (17.1 %) were randomized according to the study protocol (TPBS 104 and DGW 99). PEP developed in 14/104 patients (13.5 %) in the TPBS group and 16/99 patients (16.2 %) in the DGW group ( = 0.69). No difference existed in PEP severity between the groups. The rate of successful deep biliary cannulation was significantly higher with TPBS (84.6 % [88/104]) than with DGW (69.7 % [69/99]; = 0.01).
In difficult biliary cannulation, there was no difference in PEP rate between TPBS and DGW techniques. TPBS is a good alternative in cases of difficult cannulation when the guidewire is in the pancreatic duct.
内镜逆行胰胆管造影术（ERCP）中胆管插管困难会增加ERCP术后胰腺炎（PEP）的风险。这项前瞻性、随机、多中心研究的目的是比较两种先进的补救方法，即经胰胆管括约肌切开术（TPBS）和双导丝（DGW）技术，用于困难的胆总管（CBD）插管。
在八家斯堪的纳维亚医院招募有天然乳头且计划进行CBD插管的患者。由经验丰富的内镜医师尝试通过导丝引导进行CBD插管。如果该操作符合困难插管的定义且导丝进入胰管，则随机分为TPBS组或DGW组。如果随机分配的方法失败，则采用任何可用的方法。主要终点是PEP的发生率，次要终点包括随机分配方法成功插管的情况。
总共招募了1190例患者，其中203例（17.1%）根据研究方案进行了随机分组（TPBS组104例，DGW组99例）。TPBS组104例患者中有14例（13.5%）发生PEP，DGW组99例患者中有16例（16.2%）发生PEP（P = 0.69）。两组之间PEP严重程度无差异。TPBS组成功进行深部胆管插管的比例（84.6% [88/104]）显著高于DGW组（69.7% [69/99]；P = 0.01）。
在困难胆管插管中，TPBS和DGW技术在PEP发生率上无差异。当导丝位于胰管时，TPBS是困难插管情况下的一种良好替代方法。
