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• W2079594085 abstract "Endoscopic sphincterotomy conquered the biliary system for the endoscopist in the year 1974. This meta-morphed the humble gastrointestinal (GI) endoscopist into a minimally invasive therapist, who could now challenge surgeons to emulate their feats in other areas. The object of war is victory; that of victory is conquest; and that of conquest preservation. (Charles de Secondat) Although sphincterotomy is a prerequisite to most therapeutic endoscopic retrograde cholangiopancreatographies (ERCP), preservation of the anatomical and functional integrity of the sphincter choledochus (Sphincter of Oddi) remains a major concern. Ablation of the sphincter leads not only to duodeno-biliary reflux, a well-known consequence, but also biliary incontinence (i.e. continuous flow as opposed to the rhythmic, well-timed release of bile). Endoscopists owe a debt to radiologists for showing them the way to access the biliary tree, without the cutting, for therapeutic procedures. For, in 1981, it was Centola, an interventional radiologist unarmed with surgeon's knife or endoscopist's sphincterotome, who displayed the ingenuity to dilate the papilla with an angioplasty balloon in order to extract a bile duct stone.1 The first report of endoscopic papillary balloon dilation followed in 1982,2 and this culminated in a series of reports on balloon dilation for successful extraction of bile duct stones over the ensuing years.3 Papillary balloon dilation (PBD) or endoscopic sphincteroplasty was thus born. The holy grail of evidence-based medicine, randomized controlled trials (RCT), has shown PBD to be almost as effective as sphincterotomy for stone removal, thereby establishing it as a standard procedure.4,5 However, subsequent RCT have concluded that endoscopic sphincterotomy should remain the standard procedure for removing common bile duct (CBD) stones6–9 (Table 1). Eventually, a meta-analysis confirmed PBD to be as effective as sphincterotomy,10 but a Cochrane systematic review found it to be slightly less effective than sphincterotomy.11 What are the effects of PBD on sphincter of Oddi function and structure? Manometric studies have shown that there is only a temporary reduction in the sphincter pressure. This returns to normal early, and remains so in the long term,12,13 although one study has shown a mild persistent decrease in sphincter pressure following PBD.14 A histological study showed no evidence of fibrosis at the papilla following PBD.15 PBD avoids both the immediate and the late complications of sphincterotomy, such as bleeding at the time of procedure, and subsequent biliary complications due to duodeno-biliary reflux. However, PBD has its own set of problems. Two of them are important – an increased need for mechanical lithotripsy, and an increased risk of post-PBD pancreatitis.10,11 Pancreatitis remains a major concern, although some of the studies did not find any definite increase in rates of pancreatitis following PBD.5,16 The risk factors for post-PBD pancreatitis include contrast injection into the pancreatic duct, poor minor papilla function, long procedure time, and high balloon inflation pressure of > 5 atm.17,18 As balloon pressure seems to be an important factor for pancreatitis, Tsujino et al. have shown, in this issue of the Journal, that a modification of the technique of PBD might result in a lower incidence and attenuated severity of pancreatitis.19 In a multi-center study of 324 patients, they demonstrated that inflating the balloon until its waist disappears, rather than inflating to a pre-specified pressure, and keeping it inflated only for 15 s rather than the conventional 2 min, appeared to lower the incidence of pancreatitis. Although this apparent difference was not statistically significant, the pancreatitis was less severe without compromising the efficacy of PBD, as compared with the conventional method using historical controls. There is, however, a conceptual problem with the inflation pressure being causally related to the occurrence of pancreatitis. This is that the dilation balloons have a very low compliance and thus the pressure transmitted to the papilla should depend on the diameter of the expanded balloon rather than on the inflating pressure. Inflation time might be more important, but Tsujino et al. did not find either the inflation pressure or the inflation time to be a significant factor for pancreatitis on multivariate analysis. In their study, pancreatic duct opacification was the only factor responsible for post-ERCP pancreatitis; this has been shown earlier in numerous studies on the risk factors for post-ERCP pancreatitis. There are certain weaknesses in the Tsujino study. These include the non-randomized trial design, and inappropriate analysis. Thus, the authors combined the patients of the current study with historical controls and studied the significance of different variables between the pancreatitis and non-pancreatitis groups. This analysis was unlikely to find any difference between the groups with regard to balloon inflation pressure or inflation time because the conventional and modified techniques were represented equally in both the pancreatitis and the non-pancreatitis groups. Had they compared patients with pancreatitis in the historical control group and those with pancreatitis in the modified group, they would have been able to test the significance of inflation pressure and time while controlling for other covariables such as endoscopist's experience, contrast injection into the pancreatic duct etc. Notwithstanding the issues related to the physical principles of very low compliance balloons and statistical analysis, the modifications adopted by the authors stand to reason. If the balloon is inflated fully to its size and the diameter of the stone is less than or equal to that of the balloon, the stone should be easily removable regardless of the pressure or the time of inflation. Thus, the study by Tsujino et al. is an important addition to the growing literature on PBD to document that less (pressure and inflation time) is both equal (in terms of success) as well as better (for complications). Should we then stretch the sphincter for stone extraction? That's the question. The advantages of PBD include not only avoidance of complications of sphincterotomy such as bleeding, but also technical advantages. One can simply do away with problems like determining the extent and direction of cut, strength and type of current (pure, blended or autocut), type of sphincterotome, and the experience required for sphincterotomy. In my opinion, an answer in the affirmative should be qualified. For patients with coagulopathy (e.g. those with cirrhosis of the liver), for patients with Billroth II anatomy, and for pediatric patients in whom sphincter ablation may lead to long-term consequences, PBD should be the procedure of choice.11,20,21 In a 7-year old child with CBD stone, dilation with a 6 mm balloon for 30 s was sufficient to extract a stone, in the author's recent experience. For all other patients, and in patients with large stones, multiple stones, recurrent stones and, possibly, in those with a history of pancreatitis, endoscopic sphincterotomy should remain the standard procedure. Patients with large bile duct stones require mechanical lithotripsy and multiple procedures and, hence, sphincterotomy might be a better option.22 One of the advantages of a good-sized sphincterotomy is that it is equivalent to surgical choledochoduodenostomy; this is indicated in patients with large and recurrent stones, and in those with primary CBD stones to prevent bile stagnation and recurrent stone formation.23 Further trials are warranted with the modified balloon inflation technique combined with other strategies to prevent pancreatitis, such as the addition of guidewire cannulation.24 If shown to be effective and safe, such trials would help establish PBD as the procedure of choice for removing bile duct stones in younger patients. It is noted that, in contemporary practice, sphincterotomy and balloon dilation are not mutually exclusive. In an endoscopic marriage of sorts, both the techniques have been combined and to good effect. Recent series have shown that a combination of sphincterotomy and balloon dilation results in a high success rate for removing large and difficult-to-remove bile duct stones, with much less need for mechanical lithotripsy.25,26 Thus, papillary balloon dilation may be used either as a primary or as an adjunct modality for patients with CBD stones, establishing the importance of this procedure. Whether the choice is sphincterotomy, balloon dilation or a combination of the two, one thing is for sure: while stones in the gallbladder do not yet interest the endoscopist, the same stones in the bile duct do, and that interest is intense. So much for the change of residence!" @default.
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• W2079594085 title "Refining papillary balloon dilation: Less is better!" @default.
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