Analysis of Adverse Events Associated with Endoscopic Papillary Large-Balloon Dilation

Abstract

We read with great interest the article by Park et al. [1] entitled ‘‘Factors predictive of adverse events following endoscopic papillary large-balloon dilation: results from a multicenter series’’. In this multicenter study, the authors analyzed adverse events (AEs) after endoscopic papillary large-balloon dilation (EPLBD) in 946 patients and revealed that cirrhosis, stone size equal or larger than 16 mm, full endoscopic sphincterotomy (EST), continued balloon inflation despite persistent waist formation and distal common bile duct (CBD) stricture were predictors of significant AEs such as perforation and severe bleeding. Interestingly, the authors reported that the larger balloon size ([14 mm) is protective against the development of post-procedure pancreatitis. The paper by Park et al. nicely described those factors predictive of these AEs. However, we have some concerns with some of their findings. We know that EPBD is mostly suitable for patients with coagulopathy including those due to cirrhosis and EST is relatively contraindicated in them [2]. Indeed, it is not clear in the text that the 18 patients with cirrhosis in the present study had EST plus EPLBD or only EPLBD. If these cases had undergone combined approach, we also do not know how much of them had full EST which is the dominant factor for the intra or post procedure bleeding in these cases. In line with this, one of the patients with thrombocytopenia (probably due to cirrhosis) in this study developed severe bleeding after combined approach of full EST plus EPLBD and this patient died. We believe that such a combined approach in a thrombocytopenic patient must not be used at all and it should be accepted as contraindicated. Another point with this paper is that three patients developed post-procedure perforation and again it seems that two of them had full EST plus EPLBD therapy and the balloon sizes were noted to be larger than the size of distal CBD. Although it is not clear in the paper if the second case with post-procedure perforation had full EST as well, it is already known that patients with distal CBD stenosis or a narrow CBD are at risk of perforation, bleeding, and or bile duct injury [3]. Full EST also increases the risk of perforation itself and in daily practice; we always prefer partial EST and combine it with EPLBD since direct observation of the remaining intact papillary roof during gradual balloon inflation is possible during partial EST. This helps us to avoid perforation. The authors explained the reasons for perforation in these three cases only with over-inflation and rapid inflation of the balloon. We believe that full EST might also have contributed to perforation in these cases. Moreover, during the EPLBD procedure, it is a general rule to avoid excessive dilatation against a resistance and if the waist in the balloon decreases but not disappear completely, in such cases keeping the balloon in place for more than 45 s may be useful and secure rather than forcing it to disappear completely. Another flaw with this paper is that the authors indicated that a balloon size larger than 14 mm is protective against pancreatitis and it is not clear in the text if those cases had EST (partial or full?) or not. In cases undergoing EST plus EPLBD, EST separates pancreatic orifice from biliary orifice and this is believed to be protective for Y. Ustundag (&) Department of Internal Medicine, Gastroenterology Clinics, Bulent Ecevit University Hospital, Zonguldak Karaelmas University, 67600 Kozlu, Zonguldak, Turkey e-mail: yucelustundag@yahoo.com.tr