Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones

Research article Open Access Open Peer Review Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones Jae Chul Hwang1, Jin Hong Kim1Email author, Sun Gyo Lim1, Soon Sun Kim1, Sung Jae Shin1, Kee Myung Lee1 and Byung Moo Yoo1 BMC Gastroenterology201313:15 https://doi.org/10.1186/1471-230X-13-15 ©  Hwang et al.; licensee BioMed Central Ltd. 2013 Received: 13 October 2012Accepted: 10 January 2013Published: 17 January 2013 Open Peer Review reports Abstract Background Endoscopic sphincterotomy (EST) combined with large-balloon dilation (LBD) has been proposed as an alternative to manage large bile duct stones. However, recent reports indicate that LBD without EST may be safe and effective in this setting. Methods One hundred thirty-one patients with large common bile duct (CBD) stones 12 mm in size or larger underwent LBD alone (n = 62) or EST plus LBD (n = 69) for lithotripsy. The therapeutic outcome and complications were reviewed and compared. Results There were no differences between the two groups with regard to age, size and number of stones, or bile duct diameter. The LBD alone group (mean age, 70.4 years) and the EST plus LBD group (mean age, 68.2 years) had similar outcomes in terms of overall successful stone removal (96.8% vs. 95.7%, P = 0.738) and complete stone removal without the need for mechanical lithotripsy (80.6% vs. 73.9%, P = 0.360). Complications in the LBD alone and EST plus LBD groups were as follows: pancreatitis (6.5% vs. 4.3%, P = 0.593), impaction of basket and stone (0% vs. 1.4%, P = 0.341), and perforation (0% vs. 1.4%, P = 0.341). Conclusions LBD alone may be a simple, safe, and effective alternative to EST plus LBD in relatively aged patients with large CBD stones, and it can simplify the procedure compared with EST plus LBD. Keywords Common bile duct stonesEndoscopic sphincterotomyLarge-balloon dilation Background Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important techniques in the treatment of bile duct stones. It is usually combined with endoscopic sphincterotomy (EST) to extract bile duct stones using a standard balloon or basket catheter. Alternatively, endoscopic papillary balloon dilatation (EPBD) has been proposed for this indication because it is thought to preserve the function of the sphincter of Oddi and lessen the complications seen with EST, such as hemorrhage and perforation [1–4]. EPBD is technically easier than EST, especially if sphincterotome control is difficult, the margin for cutting is limited, or the appropriate cutting direction is in question [5]. However, EPBD has been associated with a higher risk of pancreatitis after ERCP [6–8]. Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure, which likely lengthens the procedure time. A number of studies have been conducted using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones [9–13]. In those studies, the authors suggested that EST plus LBD might lower the risk of postprocedure pancreatitis by directing balloon dilation toward the bile duct rather than the pancreatic duct [9–13]. However, recent studies have shown that LBD without preceding EST is safe and effective in patients with large common bile duct (CBD) stones [14, 15]. We conducted the present study to compare the therapeutic outcome and complications between LBD alone and EST plus LBD for the treatment of large bile duct stones. Methods The ERCP database at our institution was searched for prospectively collected data on patients with large bile duct stones who underwent LBD from March 2004 to April 2009. During the study period, 2665 ERCPs were performed at our institution. The patients were identified from the database using a search query and the medical records of the patients were reviewed using a standardized data entry form. From March 2004 to February 2008, LBD was routinely performed with EST, while LBD alone (without EST) was performed from March 2008 to April 2009. LBD without EST was introduced into this hospital in March 2008 and used for the treatment of large bile duct stones. We have conducted a prospective, randomized, comparative study to validate LBD without EST as an effective and safe treatment for endoscopic removal of large bile duct stones since May 2009. We analyzed the data before and after the omission of EST to investigate its effect on the success of stone clearance and complications. Patients with visualized bile duct stones ≥12 mm in maximum transverse diameter were included. Exclusion criteria were (1) bleeding diathesis, (2) prior EST or EPBD, (3) Billroth II or Roux-en-Y anatomy, (4) distal extrahepatic bile duct stenosis, (5) acute pancreatitis, and (6) intrahepatic bile duct stones. Based on these criteria, 62 patients were included in the LBD alone group and 69 patients were included in the EST plus LBD group. This study was approved by our institutional review board, and informed consent was obtained from all patients for the endoscopic procedures performed. ERCP was performed with side-viewing endoscopes (Olympus JF-240 or TJF-240; Olympus Optical Co., Ltd., Tokyo, Japan). Each patient was sedated with a standard dose of midazolam, propofol, and meperidine. After the CBD was selectively cannulated using a sphincterotome, an initial cholangiogram was taken. Diameters of the bile duct and stones were measured during ERCP and corrected for magnification using the external diameter of the duodenoscope’s distal end as a reference. In the EST plus LBD group, EST was performed before LBD from the orifice of the papilla proximally to the transverse fold (minor EST). Wire-guided hydrostatic balloon catheters (Boston Scientific Microvasive, Cork, Ireland) that can be dilated to the three distinct diameters listed on the package and hub labels were positioned across the major papilla with the balloon mid-portions placed at the biliary sphincter. The balloon was then gradually inflated to the pressure corresponding to the smallest balloon diameter with dilute contrast medium until the waist of the balloon had disappeared under fluoroscopic guidance. Thereafter, the pressure for inflation of the balloon was gradually increased until the desired dilation was achieved. Once the dilation to the desired diameter was achieved, the balloon was maintained in position for 60 seconds and then deflated and removed. The balloon diameters used were 12 to 20 mm, and the diameter of the balloon was selected according to the sizes of the stones and bile duct proximal to the tapered segment under fluoroscopic guidance. The bile duct stones were removed with a Dormia basket or retrieval balloon (Figures 1 and 2). A mech (...truncated)