The Pancreas and Biliary Center, Beth Israel Medical Center, New York, NY
The author declares that he has nothing to disclose.
Reprints: Franklin E. Kasmin, MD, The Pancreas and Biliary Center, Beth Israel Medical Center, 305 2nd Ave, suite #3, New York, NY 10003. (e-mail: firstname.lastname@example.org).
Balloon dilation for the extraction of common duct stones was first described in 1983.1 The early interest in this alternative to sphincterotomy reflected the recognized and feared complications of sphincterotomy-related perforation and hemorrhage. Subsequently, the recognition of the occurrence of recurrent biliary stone disease in the postsphincterotomy state led to the hypothesis that this might be in part related to the contamination of the bile duct secondary to the permanent ablation of the sphincter.2 Findings such as those by the Amsterdam group3 that the long-term recurrence of papillary stenosis and or bile duct stone disease following sphincterotomy is as high as 24% were indeed sobering.
Papillary balloon dilation became a popular alternative to sphincterotomy, especially in Europe and Asia, with admirable success rates in the extraction of stones, especially those <1 cm in size. Of some concern was an apparent mild increase in the rate of pancreatitis, and hence a multicenter US-based international study was undertaken to assess the safety and efficacy of balloon dilation in a rigorous manner.4 Unfortunately, 2 patients in that study developed fatal pancreatitis, and thus US-based physicians lost enthusiasm for this procedure. Of note was the fact that those 2 patients did not have stones in actuality and may have instead been patients with sphincter of Oddi dysfunction, placing them at high risk for pancreatitis after dilation. In addition, pancreatic stents after dilation were not in wide use.
Additional publications outlining ongoing European and Asian experiences with balloon sphincteroplasty were produced, and efficacy with an overall morbidity similar to sphincterotomy was demonstrated, albeit with at times a mild increase in pancreatitis (and less perforation and bleeding). Familiarity with balloon dilation, which was initially performed with an 8 or 10 mm balloon, led to the use of larger balloons, typically 15 to 20 mm in size, which has allowed the extraction of larger stones. The larger balloons have been used de novo or immediately following the performance of a limited sphincterotomy (recognizing that balloon dilation immediately following a completed sphincterotomy might result in an uncontrolled tear). Large balloon dilation, either during the index ERCP or subsequently, has proven remarkably effective at extracting large stones and has been repeatedly demonstrated to be safe, especially in the 12 to 16 mm balloon sizes or with larger balloons when slow gradual dilation techniques are used. Thus, even in the United States, large balloon dilation of the papilla is rapidly gaining acceptance as the procedure of choice for complex stone burdens.
The report of transpapillary balloon dilation in 298 patients by Kuo et al5 in this issue of The Journal of Clinical Gastroenterology reflects a mixture of techniques and a sizeable experience at a single institution. The authors utilized both large and small balloons, employed mechanical lithotripsy when needed, and did not perform sphincterotomy as long as deep cannulation was achieved. Note should be made of the fact that this was a retrospective look at a consecutive group of patients. Success at stone extraction was assessed, and variables leading to success and failure were analyzed. Short-term and long-term complications were studied, and as expected the primary short-term complication was pancreatitis, at a rate of 10.1%. The primary long-term complication was recurrence of bile duct stones, and factors associated with this risk were discussed. Of note is the fact that pancreatic stents were not routinely used in sphincteroplasty patients.
The overall success rate of stone extraction in this study was 92%, which is consistent with the results in previous series. The success rate was 95% when the stones were <1 cm in size and 83% when larger stones were addressed. Aside from pancreatitis, there was a 3% rate of cholecystitis, a 3% rate of cholangitis and sepsis, a 0.3% rate of both bleeding and perforation, and 2 deaths, both of uncertain relationship to the procedure. As indicated, the pancreatitis rate was 10.1%. Variables significantly associated with the development of pancreatitis included age less than 60 years, female sex, and the injection of contrast into the pancreatic duct.
Long-term complications were primarily manifest by the recurrence of symptomatic common duct stones, which occurred in 12 patients over a follow-up period of 48 months. As this study was retrospective in nature, and without routine follow-up imaging, the rate of recurrent stone disease is likely even higher. When patient or procedural variables were assessed, only a prolonged balloon dilation of over 3 minutes was associated with recurrent stones. Interestingly, the presence of an intact gallbladder with stones was not significantly associated with recurrent common duct stones.
What can we learn from this newest addition to the transpapillary balloon dilation literature? First, there is indeed an important complication rate associated with the procedure. The 16% morbidity is higher than that in most series of sphincterotomy for stone disease, and the excess in the complications in this study was pancreatitis. Presumably this is related to sphincter trauma from either the dilation or the stone extraction itself. Given that pancreatic stents reduce the incidence of pancreatitis by drainage of the duct across the sphincter following manipulation, one wonders whether the addition of routine pancreatic stenting in this series of patients would have substantially reduced both the pancreatitis rate and the overall complication rate toward 6% and 10%, respectively, as typically seen in sphincterotomy and stone extraction trials. It is true that attempting to place a wire in the pancreatic duct solely for the purpose of prophylactic stenting involves not only additional contrast injection but the risk of guidewire trauma and hence is in and of itself a risk factor for the development of pancreatitis. However, a 10% pancreatitis rate is indeed substantial, and prophylactic measures should be considered. The recent finding that indomethacin suppositories halved the rate of pancreatitis in a high-risk subset of patients6 may change clinical practice in high-risk pancreatitis cases and might be a good alternative to stenting in these cases.
Next, there is the question of the role in sphincter preservation in the prevention of recurrent choledocholithiasis. Although most other studies have demonstrated the presence of an intact gallbladder as the primary risk factor for recurrent stones, the present study indicates that only prolonged dilation plays a significant role. Thus, one would presume that extended dilation times might cause persistent sphincter patency, presumably allowing biliary contamination and stone formation. Perhaps both factors, sphincter ablation as well as the intact gallbladder, play a role in recurrent stones. Given the substantial rate of long-term biliary complications following sphincterotomy, short-duration balloon dilation for stone disease, perhaps in conjunction with cholecystectomy as indicated, has an appeal.
In my mind, transpapillary balloon dilation offers substantial advantages over sphincterotomy for stone disease—namely, a lower bleeding risk, the ability to perform stone therapy in anticoagulated patients, and perhaps a lower risk of the long-term complication of recurrent stone disease. However, the high rate of pancreatitis does give pause to those considering a change to dilation from sphincterotomy. For those endoscopists, the use of prophylactic maneuvers to reduce the risk of pancreatitis, especially an easy-to-administer therapy like indomethacin, might just change the way endoscopists view the risk of balloon dilation, changing practice patterns.
1. Staritz M, Ewe K, Meyer zum Buschenfelde KH. Endoscopic papillary dilation (EPD) for the treatment of common bile duct stones and papillary stenosis. Endoscopy. 1983;15:197–198
2. Gregg JA, De Girolami P, Carr Locke DL. Effects of sphincteroplasty and endoscopic sphincterotomy on the bacteriologic characteristics of the common bile duct. Am J Surg. 1985;149:669–671
3. Bergman JJ, van der Mey S, Rauws EA, et al. Long-term follow-up after endoscopic sphincterotomy for bile duct stones in patients younger than 60 years of age. Gastrointest Endosc. 1996;44:643–649
4. Disario JA, Freeman ML, Bjorkman DJ, et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology. 2004;127:1291–1299
5. Kuo C-M, Chiu Y-C, Changchien C-S, et al. Endoscopic papillary balloon dilation for removal of bile duct stones: evaluation of outcomes and complications in 298 patients. J Clin Gastroenterol. 2012;46:860–864
6. Elmunzer BJ, Scheiman JM, Lehman GA, et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012;366:1414–1422