Large hydrostatic balloon for choledocolithiasis

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1 1130-0/2007//1/33-3 REVISTA ESPAÑOLA DE ENFERMEDADES DIGESTIVAS Copyright 2007 ARÁN EDICIONES, S. L. REV ESP ENFERM DIG (Madrid) Vol.. N. 1, pp. 33-3, 2007 Large hydrostatic balloon for choledocolithiasis J. Espinel, E. Pinedo 1 and J. L. Olcoz Departments of Gastroenterology and 1 Radiology. Hospital de León. León, Spain ABSTRACT Aim: to assess the efficacy and safety of hydrostatic dilatation with large balloons for the treatment of choledocolithiasis in patients with difficult or risky extraction due to stone characteristics or peripapillary anatomy. Design: prospective. Patients: this study included 22 patients in whom a hydrostatic dilatation of the papilla with large balloons was performed between June 2005 and April 200. Patients had multiple large stones, tapered distal common bile duct, peri/intradiverticular papilla, previous sphincterotomy, or Billroth-II surgery. Esophageal, pyloric and colonic CRE dilatation balloons with diameters ranging from 12 to 20 mm (Boston Scientific Corporation) were used. Results: stone removal was achieved in a single session in all patients (0%). Most procedures (73%) did not require an extended exploration time. There were no complications. Hyperamilasemia was detected in 1% of patients. Conclusions: hydrostatic papillary dilatation with large balloons is a simple, effective, and safe technique for the removal of difficult stones located in the distal common bile duct. It does not add to exploration time, nor increases complications, and reduces the need for lithotripsy. Further studies are needed to define the usefulness of this technique. Key words: Papillary dilatation. Hydrostatic balloon. Choledocolithiasis. Endoscopic retrograde cholangiopancreatography (ERCP). Post-ERCP complications. Pancreatitis. Hyperamilasemia. Espinel J, Pinedo E, Olcoz JL. Large hydrostatic balloon for choledocolithiasis. Rev Esp Enferm Dig 2007; : Received: Accepted: Correspondence: Jesús Espinel Diez. C/ Brianda de Olivera, 13, esc-2, 3ºB León. jespinel@telefonica.net INTRODUCTION Endoscopic sphincterotomy (ES) is the most commonly used technique for the treatment of CBD stones. Hydrostatic papillary dilatation (HPD) was first described in 13 (1) but it only became a therapeutic option, mainly outside the USA, years later. HPD is an effective alternative to ES with a success rate of 5-0% and a reduced incidence of perforation and bleeding (2-). Some publications found a higher risk of pancreatitis (4,-12), not confirmed by others (,13,14). Most series use small diameter balloons (- mm). Studies using larger balloons (esophageal/pyloric/colonic dilatation balloons, from 12 to 20 mm) in this setting are rare (15,1). The aim of the present study was to assess the efficacy of hydrostatic dilatation with large balloons (HDLB) for the removal of CBD stones in patients with difficult or risky extraction due to stone characteristics (large, multiple) or to peripapillary anatomy (tapered distal CBD, peri/intradiverticular papilla, previous sphincterotomy, or Billroth-II surgery). We analyzed removal success rates, number of sessions, use of lithotripsy, exploration time, and complications. PATIENTS AND METHODS A prospective study including 22 patients ( male, 1 female; mean age: 73.7; range 5-2) between June 2005 and April 200. Twelve patients had undergone a previous cholecystectomy (54.5%). Three patients had been admitted to the hospital with cholangitis (13.%). Indications for HDLB included: large stones ( 15 mm), multiple stones ( 3), tapered or conic distal CBD (disparity between stone size and CBD diameter), previous sphincterotomy, peri/intradiverticular papilla, and Billroth-II surgery. All patients received deep sedation (propofol) administered by an anesthesiologist. Esophageal, pyloric and colonic CRE dilatation balloons, with diameters ranging from 12 to 20 mm (Boston Scientific Corporation), were used to perform a progressive dilatation. Di-

2 34 J. ESPINEL ET AL. REV ESP ENFERM DIG (Madrid) luted contrast was used to confirm, under endoscopic and fluoroscopic control, the correct transpapillary position and gradual disappearance of balloon compression by the biliary sphincter waist (Fig. 1). The balloon was then kept inflated for seconds before removal. Balloon diameter was chosen according to the size of stones and the CBD proximal to the tapered distal end (never bigger than the diameter of the proximal CBD). Sphincterotomy was not performed in patients with a Billroth-II, and it was not enlarged in those with previous sphincterotomy. No pancreatic stents were placed for the prophylaxis of pancreatitis. All patients received antibiotic prophylaxis for 24-4 hours. Blood cell count and serum amylase were measured at h and 24 h post-procedure. Patients were followed up till hospital discharge, and were contacted by phone 30 days after in order to detect outpatient complications as defined by pre-established criteria (17). Hyperamylasemia was defined as an amylasemia rising above 3 times the normal value within 24 hours. Exploration time was considered: short: < 15 min; normal: min; extended: min; very laborious: > 45 min. An informed consent was obtained for all patients. RESULTS Patient characteristics are shown in table I. Sphincterotomy was not performed in patients with a previous sphincterotomy or Billroth-II surgery. It was performed in 7/ (70%) of the remaining patients. Stone removal Stone removal was achieved in a single session in all patients (0%). One patient required mechanical lithotripsy (4.5%) (Table II). Exploration time Exploration time was less then 45 minutes in 1 patients (73%) (Fig. 2). Balloon diameters Balloon diameters are shown in figure 3. Complications There were no complications. Painless hyperamylasemia was detected in 4 patients (1%) (Table II). DISCUSSION Hydrostatic dilatation with large balloons is an effective technique for the removal of CBD stones in patients with big or multiple stones or in whom peripapillary anatomy might imply a difficult or dangerous extraction. In our study stone removal was achieved in a single session in all patients. We used balloon dilators with a diameter (12-20 mm) much bigger than that of standard ones (- mm). We started using standard dilators in 2001, and our results are in line with those published by other authors (7). This initial experience has facilitated their adoption by other, more reticent endoscopists, and has Fig. 1. Choledocholitiasis of 13 x 20 mm in a patient with intradiverticular papilla and tapering CBD. Sphincterotomy progressive hydrostatic dilatation (15 mm) and extraction.

3 Vol.. N. 1, 2007 LARGE HYDROSTATIC BALLOON FOR 35 CHOLEDOCOLOTHIASIS Table I. Characteristics of 22 patients (HDLB) n Sex Age Previous ID/PD Billroth-II CBD Stone (mm) ES + HDLB Mechanical Exploration Stone removal Amilase Complications (years) ES papilla (mm) *multiple HDLB (mm) lithotripsy time 1 session x 3 1 F Yes - No 2 M * > 45 Yes - No 3 F > 45 Yes - No 4 F * Yes - No 5 F * Yes - No M * Yes - No 7 M * > 45 Yes + No F * Yes - No F Yes - No F * * Yes - No 11 F > 45 Yes - No F * Yes - No 13 F Yes - No 14 F * Yes - No 15 M Yes + No 1 F * Yes - No 17 F Yes - No 1 F Yes - No 1 1 F * > 45 Yes + No F Yes + No (see next page)

4 3 J. ESPINEL ET AL. REV ESP ENFERM DIG (Madrid) Table I. Characteristics of 22 patients (HDLB) (cont.) n Sex Age Previous ID/PD Billroth-II CBD Stone (mm) ES + HDLB Mechanical Exploration Stone removal Amilase Complications (years) ES papilla (mm) *multiple HDLB (mm) lithotripsy time 1 session x 3 21 M * > 45 Yes - No 7 22 M * Yes - No HDLB: hydrostatic dilatation with large balloons; M: male; F: female; ES: endoscopic sphincterotomy; *: multiple stones; ID/PD papilla: intra/peridiverticular papilla; CBD: common bile duct. : Proximal CBD diameter : Distal CBD diameter Table II. Results of the HDLB n = 22 n(%) Stone removal 22 (0) Mechanical lithotripsy 1 (4.5) Exploration time Normal (15-30 min) 13 (5) Extended (30-45 min) 3 (14) Very laborious (> 45 min) (27) Complications 0 (0) Hyperamilasemia 4 (1) , mm mm mm mm mm mm Hydrostatic balloons 1 1 Fig. 3. Balloon diameters Fig. 2. Exploration time min min > 45 min nº patients led to the finding the usefulness of HDLB for the treatment of choledocolithiasis. The Oddi s sphincter muscle fibers surround the intraduodenal segment of the CBD and the ampulla. Associated circular muscle fibers make up the CBD sphincter (sphincter of Boyden), and their aim is to offer resistance to bile flow and thus allow the gallbladder to get filled 3 while fasting, and to prevent any reflux of duodenal contents into the bile duct. Sometimes the sphincter of Oddi maintains its function even after a large sphincterotomy. Several studies on biliary manometry have shown that in most cases sphincterotomy has been incomplete (1-20). Moreover the sphincterotomy incision usually becomes smaller during the first year (21). We have less data on the effect of hydrostatic dilatation on the biliary sphincter. Some studies show that sphincter function remains intact or partially reduced after dilatation with standard dilators (5,22,23). There are no studies yet analyzing what happens to the biliary sphincter after dilatation with HDLB. It seems probable that compressing and eliminating the sphincter waist with the balloon is followed, at least temporarily, by loss of function, enabling the removal of big stones, and reducing the need for lithotripsy and exploration time. These are interesting aspects because, as has been reported, after dilatation with standard

5 Vol.. N. 1, 2007 LARGE HYDROSTATIC BALLOON FOR 37 CHOLEDOCOLOTHIASIS balloons lithotripsy may be required by % of patients with stones mm (7) and between 30-50% of patients with big stones, and 15-30% of cases might even require a bile drainage and repeat ERCP (13). In our study we performed lithotripsy only in the initial patient in whom we dared not use the optimal dilator that was in fact most suited to stone and CBD characteristics. Regarding exploration time, most ERCPs took less than 45 minutes even in patients with problematic stones. This fact, together with the fact that lithotripsy was performed in just one patient, might reflect a smaller trauma during stone removal. Ten of our patients (45%) had a previous sphincterotomy. Leung et al. (24) retrospectively analyzed risk factors for post-sphincterotomy bleeding. They found that stone impaction in the ampulla, presence of a periampullary diverticulum, and enlargement of a previous sphincterotomy are independent variables that increase the risk of bleeding. The enlargement of a previous sphincterotomy may probably increase the risk due to enhanced local vascularization (25). On the other hand, Mavrogiannis et al. (2) prospectively evaluated the safety of enlarging a previous sphincterotomy, and concluded that even though there is a trend towards a greater risk of bleeding when a sphincterotomy is repeated early, enlarging a sphincterotomy is as safe as the initial sphincterotomy for the treatment of patients with choledocolithiasis. The studies by Freeman (27) and Maltz (2) are in line with this idea. Not taking into account these results, it is clear that enlarging a previous sphincterotomy will not please endoscopists, as incision limits are often difficult to establish and they fear complications. Six patients (27%) had an intra- or peridiverticular papilla. This has been associated in some studies with a greater risk for post-sphincterotomy bleeding (24,27,2). Two patients (%) had a Billroth-II gastrectomy. Sphincterotomy in this setting can be difficult and potentially risky. Several studies have evidenced the usefulness of dilating the papilla with standard dilators for the treatment of choledocolithiasis (7,30-33). There are still no published data on HDLB. Our results show the efficacy and safety of this technique in patients with difficult stones in whom the characteristics of their peripapillary anatomy might prevent a full and safe sphincterotomy (previous sphincterotomy, intra-/ peridiverticular papilla, Billroth-II), with no complications. Hyperamylasemia was detected in four patients (1%), with values lower than those seen in other studies using standard dilators (7,12,34-3). Sphincterotomy prior to HDLB was performed in 7 out of patients (70%) with no previous sphincterotomy or Billroth-II gastrectomy. The two studies published on HDLB, one of them in abstract form, also used prior sphincterotomy (15,1). It may be possible that sphincterotomy preserves the pancreatic orifice from compression due to HDLB, or that it frees the muscle fibers entwined with the pancreatic sphincter, thus reducing the incidence of hyperamylasemia and the risk of pancreatitis (15). CONCLUSIONS Hydrostatic papillary dilatation with large balloons is a simple, safe, and effective technique for the removal of difficult CBD stones. It does not increase the exploration time or the complication rate, and reduces the need for lithotripsy. Further studies are needed to define the usefulness of this technique. ACKNOWLEDGEMENTS We gratefully acknowledge Rosa Malagón Rojo and Gabriela Pastor for their collaboration in writing this paper. REFERENCES 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 13;15 Suppl 1: May GR, Cotton PB, Edmunds SEJ, Chong W. Removal of stones from the bile duct at ERCP winthout sphincterotomy. Gastrointest Endosc 13; 3: Mac Mathuna P, White P, Clarke E, Lennon J. Crowe J. Endoscopic sphincteroplasty: a novel and safe alternative to papillotomy in the management of bile duct stones. Gut 14; 35: Mac Mathuna P, White P, Clarke E, Merriman R, Lennon J. Crowe J. Endoscopic balloon sphincteroplasty (papillary dilation) for bile duct stones: efficacy, safety and follow-up in 0 patients. Gastrointest Endosc 15; 42: Minami A, Nakatsu T, Uchida N, Hirabayashi S, Fukuma H, Morshed SA, et al. Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones. A randomized trial with manometric function. Dig Dis Sci 15; 40: Komatsu Y, Kawabe T, Toda N, Ohashi M, Isayama M, Tateishi K, et al. Endoscopic papillary balloon dilation for the management of common bile duct stones: experience of 22 cases. Endoscopy 1; 30: Espinel J, Muñoz F, Vivas S, Dominguez A, Linares P, Jorquera F, et al. Dilatación de la papila de Vater en el tratamiento de la coledocolitiasis en pacientes seleccionados. Gastroenterol Hepatol. 2004;27:-.. Park do H, Kim MH, Lee SK, Lee SS, Choi JS, Song MH, et al. Endoscopic sphincterotomy vs. endoscopic papillary balloon dilation for choledocholitiasis in patients with liver cirrhosis and coagulopathy. Gastrointest Endosc 2004; 0: Kozarek RA. Balloon dilatation of the sphincter of Oddi. Endoscopy 1; 20: Disario JA, Freeman ML, Bjorkman DJ, Macmathuna P, Petersen BT, Jaffe PE, et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology 2004; 127: Baron TH, Harewood GC. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile duct stones during ERCP: a metaanalysis of randomized, controlled trials. Am J Gastroenterol 2004: : Arnold JC, Benz C, Martin WR, Adamek HE, Riemann JF. Endoscopic papillary balloon dilation vs. sphincterotomy for removal of common bile duct stones: A prospective randomized pilot study. Endoscopy 2001; 33: Bergman JJ, Rauws EA, Fockens P, van Berkel AM, Bossuyt PM, Tijssen JG, et al. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bile duct stones. Lancet 17; 34:

6 3 J. ESPINEL ET AL. REV ESP ENFERM DIG (Madrid) 14. Tanaka S, Sawayama T, Yoshioka T. Endoscopic papillary balloon dilation and endoscopic sphincterotomy for bile duct stones: longterm outcomes in a prospective randomized controlled trial. Gastrointest Endosc. 2004; 5: Ersoz G, Tekesin O, Ozutemiz AO, Gunsar F. Biliary sphincterotomy plus dilation with a large balloon for bile duct stones that are difficult to extract. Gastrointest Endosc 2003; 57: Bang S. Endoscopic papillary balloon dilation with large balloon after partial endoscopic schincterotomy for retrieval of choledocholithiasis. Endoscopy 2005; 37 (supl I) A Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RCG, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 11; 37: Ponce J, Sala T, Pertejo V, Pina R, Berenguer J. Manometric evaluation of sphincter of Oddi after endoscopic sphincterotomy, and in patients with previous surgical sphincterotomy. Endoscopy 13; 15: Gregg JA, Carr-Locke DL. Endoscopic pancreatic and biliary manometry in pancreatic, biliary, and papillary disease, and after endoscopic sphincterotomy and surgical sphincteroplasty. Gut 14; 25: Ugljesic M, Bulajic M, Milosavljevic T, Stimec B. Endoscopic manometry of the sphincter of Oddi in sphincterotomized patients. Hepatogastroenterology 15; 42: Geenen JE, Toouli J, Hogan WJ, Dodds WJ, Stewart ET, Mavrelis P, et al. Endoscopic sphincterotomy: follow-up evaluation of effects on the sphincter of Oddi. Gastroenterology 14; 7: Sato H, Kodama T, Takaaki J, Tatsumi Y, Maeda T, Fujita S, et al. Endoscopic papillary balloon dilatation may preserve sphincter of Oddi function after common bile duct stone management: evaluation from the viewpoint of endoscopic manometry. Gut 17; 41: Yasuda I, Tomita E, Enya M, Kato T, Moriwaki H. Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function? Gut 2001; 4: Leung JW, Chan FK, Sung JJ, Chung S. Endoscopic sphincterotomyinduced hemorrhage: a study of risk factors and the role of epinephrine injection. Gastrointest Endosc 15; 42: Geenen JE, Vennes JA, Silvis SE. Resume of a seminar on endoscopic retrograde sphincterotomy (ERS). Gastrointest Endosc 11; 27: Mavrogiannis C, Liatsos C, Papanikolaou IS, Psilopoulos DI, Goulas SS, Romanos A, et al. Safety of extension of a previous endoscopic sphincterotomy: a prospective study. Am J Gastroenterol 2003; : Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1; 335: Maltz GS, Geenen JE. Is there an increased risk of complications from repeat endoscopic sphincterotomy? Am J Gastroenterol 10; 5: 1253 (abstract). 2. Boender J, Nix GA, de Ridder MA, van Blankenstein M, Schutte HE, Dees J, et al. Endoscopic papillotomy for common bile duct stones: Factors influencing the complication rate. Endoscopy 14; 2: Cairns SR. Endoscopic balloon sphincteroplasty: use in a patient with a Billroth II gastrectomy. Endoscopy 1; 2: Dickey W, Jacob S, Porter KG. Balloon dilation of the papilla via a forward-viewing endoscope: an aid to therapeutic endoscopic retrograde cholangiopancreatography in patients with Billroth II gastrectomy. Endoscopy 1; 2: Bergman JJ, van Berkel AM, Bruno MJ, Fockens P, Rauws EA, Tijssen JG, et al. A randomized trial of endoscopic balloon dilation and endoscopic sphincterotomy for removal of bile duct stones in patients with a prior Billroth II gastrectomy. Gastrointest Endosc 2001; 53: Prat F, Fritsch J, Choury AD, Meduri B, Pelletier G, Buffet C. Endoscopic sphincteroclasy: A useful therapeutic tool for biliary endoscopy in Billroth II gastrectomy patients. Endoscopy 17; 2: Ueno N, Ozawa Y. Pancreatitis induced by endoscopic balloon sphincter dilation and changes in serum amylase levels after the procedure. Gastrointest Endosc 1; 4: Bergman JJ, van Berkel AM, Bruno MJ, Fockens P, Rauws EA, Tijssen JG, et al. Is endoscopic balloon dilation for removal of bile duct stones associated with an increase risk for pancreatitis or a higter rate of hyperamylasemia? Endoscopy 2001; 33: Sugiyama M, Izumisato Y, Abe N, Masaki T, Mori T, Atomi Y. Predictive factors for acute pancreatitis and hyperamylasemia after endoscopic papillary balloon dilation. Gastrointest Endosc 2003; 57: