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Endoscopy 2007; 39(11): 1023-1025
DOI: 10.1055/s-2007-966922
Editorial

© Georg Thieme Verlag KG Stuttgart · New York

Balloon dilation of the papilla after sphincterotomy: rescue therapy for difficult bile duct stones

S.  Attasaranya1 , S.  Sherman1
  • 1Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University Medical Center, Indianapolis, Indiana, USA
Further Information

S. Sherman, MD

Division of Gastroenterology/Hepatology

Department of Medicine

Indiana University Medical Center

550 N. University Blvd, Suite 4100

Indianapolis

Indiana 46202

USA

Fax: +1-317-278-0164

Email: ssherman@iupui.edu

Publication History

Publication Date:
16 November 2007 (online)

Also available at
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Table of Contents #

Introduction

Endoscopic papillary balloon dilation (EPBD) for removal of bile duct stones was first described in a series of nine patients by Staritz et al. in 1982 [1]. Later on, in the 1990s, with the emerging concept of preservation of the sphincter of Oddi, numerous studies reported on the use of EPBD (mainly using an 8-mm dilation balloon) as an alternative to biliary endoscopic sphincterotomy for the treatment of bile duct stones. More widespread use of EPBD has subsequently been limited, however, because of what appears to be a significant risk of pancreatitis [2] [3] [4]. In addition, it has been shown that more endoscopic retrograde cholangiopancreatography sessions and more frequent use of mechanical lithotripsy are required with EPBD in order to achieve a comparable success rate to that achievable by standard therapy with biliary endoscopic sphincterotomy [5] [6] [7]. One recent series from Japan involving 1000 patients undergoing EPBD (using balloons up to 8 mm in size) showed that lithotripsy was required for complete bile duct clearance in 77 % of the 328 patients who had stones measuring 10 mm or more but in only 6 % of the 672 patients with smaller stones [8].

The standard therapy of biliary endoscopic sphincterotomy with basket or balloon extraction is unsuccessful in 15 % of patients with difficult or larger bile duct stones [9]. Various techniques for stone fragmentation have been used as the ”rescue“ therapy for this subgroup. Among these, mechanical lithotripsy is used most commonly, with a success rate ranging from 79 % to 92 % [9]. However, this procedure can be lengthy, and up to a third of patients require a second procedure [10].

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Large-diameter EPBD after biliary endoscopic sphincterotomy

Logically, when the size of the biliary endoscopic sphincterotomy is inadequate for removal of larger stones, further widening of the biliary sphincterotomy orifice with a dilation balloon should increase the success rate, reduce or obviate the need for mechanical lithotripsy and, perhaps, shorten the procedure time. In addition, because an adequate biliary endoscopic sphincterotomy should separate the pancreatic orifice from the biliary orifice, this might make the pancreas less vulnerable to injury caused by the expansion force that occurs during balloon dilation. Hopefully, the high rate of procedure-related pancreatitis seen with EPBD alone could then be minimized.

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Clinical studies

The clinical studies of the use of biliary endoscopic sphincterotomy in conjunction with large-diameter (12 - 20-mm) EPBD to treat patients with difficult stones are summarized in [Table 1] [11] [12] [13] [14] [15] [16]. The technique was first reported by Ersoz et al. in 2003 [11]. In that study, 58 patients with bile duct stones that could not be removed using standard techniques were treated with biliary endoscopic sphincterotomy followed by EPBD and were retrospectively reviewed. The success rate was 83 % in the first session of therapy, and this increased to 100 % after the second session, with or without mechanical lithotripsy. Complications were reported in 15.5 % of patients, including 3 % with mild pancreatitis and 9 % with bleeding. Since this initial study, a number of small preliminary series have been reported with somewhat varying results. Recently, two preliminary multicenter series with larger numbers of patients have been reported. One series from Korea included 166 patients with stones larger than 15 mm who underwent EPBD using 15 - 20-mm dilation balloons after either concurrent or remote biliary endoscopic sphincterotomy [12]. The success rate of removal of stones in the first session was 83 %, with a complication rate of 6.6 %, including two deaths (due to bleeding and perforation). The pancreatitis rate, however, was not mentioned. The other series, from the USA, retrospectively reviewed 93 patients (median stone size 13mm) who underwent 98 procedures using 12 - 18-mm dilation balloons [13]. The success rate in the first session was 93 %, and mechanical lithotripsy was used in 27 % of patients. Complications occurred in 4 % of all procedures, including one cystic duct perforation that was graded as severe. No pancreatitis was observed in this series.

Table 1 Summary of clinical studies on the use of biliary endoscopic sphincterotomy (BES) and large-diameter endoscopic papillary balloon dilation (EPBD ) for the removal of bile duct stones [11] [12] [13] [14] [15] [16] (four full articles [11] [14] [15] [16] and two preliminary multicenter series [12] [13])
Authors, year [ref. no.] No. of patients Age, years Extent of BES Dilation balloon diameter, mm Mean size of the largest stone, mm Success in first session Complication rates Mortality
Total Pancreatitis
Ersoz et al., 2003 [11] 58 68*/72* (median) Full 12 - 20 16*/18* (median) 83 % 16 % 3 % 0 %
Minami et al., 2007 [14] 88 74 (median) Limited ≤ 20 > 12 99 % 4.5 %† 1 % 0 %
Espinel et al., 2007 [15] ‡ 22 73 (mean) Unclear 12 - 20 13 ± 4 100 %§ 0 % 0 % 0 %
Maydeo & Bhandari, 2007 [16] 60 58 (mean) Full 12 - 15 16 95 % 8.3 % 0 % 0 %
Yoo et al., 2007 [12] 166 69 (mean) Unclear 15 - 20 16.1 ± 5.4 83 % 6.6 % n. m. 1.2 %&
Attasaranya et al., 2007 [13] 93/98** 71 (mean) Full 12 - 18 13 (median) 93 % † † 4 % 0 % 0 %
n. m., not mentioned.
* Two subgroups were evaluated: patients with tapering of the distal bile duct and patients with large square stones.
† Not including patients who developed hypotension/hypoxia (presumed to be due to nitrate infusion).
‡ Two patients with Billroth II anatomy had only EPBD performed (not BES).
§ Mechanical lithotripsy used in one patient (4.5 %).
& Two deaths, one due to perforation and one due to bleeding.
** Number of patients/number of procedures.
† † Mechanical lithotripsy used in 27 % of procedures.

Over the same time period, two other studies were published as full articles. Minami et al. [14] reported their experience with 88 patients (with stones larger than 12 mm) who underwent ”limited” biliary endoscopic sphincterotomy followed by EPBD using larger dilation balloons (up to 20 mm). Successful stone removal was achieved in 99 % in the first session with mechanical lithotripsy required in the one remaining patient. Complications other than mild abdominal discomfort and hypoxia/hypotension (presumably secondary to a routine infusion of nitrate used during the procedure for pancreatitis prophylaxis) occurred in four patients: mild pancreatitis (n = 1), mild cholangitis (n = 1), bleeding requiring endoscopic therapy (n = 1), and asymptomatic, low-grade bile duct injury (n = 1). The other study, from Spain, prospectively performed EPBD using 12 - 20-mm dilation balloons in 22 patients with a mean stone size of 13 ± 4 mm [15]. Complete stone removal was achieved in all the patients, with adjunctive mechanical lithotripsy required in one patient. However, it is uncertain whether all the patients in these two studies had failed attempted removal of stones using standard therapy prior to EPBD.

In this issue of Endoscopy Maydeo & Bhandari [16] present their experience of performing EPBD using 15-mm dilation balloons in 60 patients with bile duct stones (mean size 16 mm) that could not be removed with an adequate biliary endoscopic sphincterotomy and balloon/basket extraction. Patients with coagulopathy, portal hypertension, altered anatomy (including periampullary diverticula), or a malignant distal biliary stricture were excluded. Complete removal of stones was accomplished in 57 patients (95 %) in one session; the three remaining patients with multiple, large stones (> 15 mm) required additional mechanical lithotripsy in a second session for complete ductal clearance. Complications, exclusively limited to bleeding, occurred in five patients (8.3 %) - all these patients required endoscopic therapy and one patient also required blood transfusion (2 units).

We would like to congratulate the authors on this first prospective series to specifically recruit only patients with ”difficult” stones for large-diameter EPBD. Procedures performed by only one single operator can also ensure technical homogeneity. The treatment outcomes shown in this series are comparable to those of previous studies. The absence of pancreatitis is encouraging. However, several issues need to be pointed out. Other factors that could have influenced the outcomes of the procedures were not reported, such as stone consistency, diameter of the bile duct, bile duct contour, and associated biliary strictures. It is unclear whether the serum pancreatic enzymes were measured routinely after the procedures. Did any patients have prophylactic pancreatic stents placed (which has been suggested to reduce the rate of pancreatitis following EPBD alone [17])? The authors reported a postprocedure bleeding rate of 8 %, which is comparable to that reported by Ersoz et al. [11].

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Areas of uncertainty

As with other evolving procedural techniques where experience remains limited, there are inevitably some questions and concerns:

  • Although all the current data have demonstrated encouraging outcomes (particularly the relatively low pancreatitis rates of 0 % - 3 %), there have been fatal complications. Further large-scale studies are still needed to define the safety of this procedure.

  • Because all the current data related to large-diameter EPBD have been derived mainly from older patients, it is uncertain whether the reported impressive outcomes (particularly the low pancreatitis rate) are applicable to younger patients.

  • What is the ”safety limit” for the size of the dilation balloon? The majority of patients included in most series to date have had mean or median stone sizes of less than 20 mm, which appears to correspond to the maximal size of the dilation balloon used. Using larger dilation balloons (> 20 mm) to retrieve larger stones would probably increase the risks.

  • Previous studies have shown that it is not uncommon for a proportion of patients to have stones that are difficult to remove with standard therapy because of disproportion between the stone size and the diameter of the distal bile duct [10] [15]. These patients could also benefit from large-diameter EPBD. However, the question arises of how far we can go in dilating this narrow portion. Is it safe to use a 20-mm dilation balloon to stretch an 8-mm bile duct?

  • Is there a role for prophylactic pancreatic stent placement in high-risk patients who are undergoing this combined technique (e. g. patients who have a difficult cannulation or precut sphincterotomy)?

  • What are the long-term outcomes in these patients? Will creating a wider biliary orifice lead to more late complications such as stone recurrence or cholangitis?

  • Last, but not the least - what is the best optimal management of difficult bile duct stones? As pointed out by Maydeo & Bhandari, further randomized trials comparing this technique and mechanical lithotripsy (or other modalities) are needed.

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Current status of large-diameter EPBD

There is mounting evidence to suggest that large-diameter EPBD, in conjunction with biliary endoscopic sphincterotomy can be considered as an alternative therapy in patients with large stones (though preferably 20 mm or less) or in patients with moderately large stones who have a narrow distal bile duct, in whom standard therapy has failed. On the basis of one previous large series [14], it might be reasonable to attempt ”partial” biliary endoscopic sphincterotomy followed by large-diameter EPBD in patients with concomitant distal bile duct or papillary stenosis or altered anatomy (e. g. periampullary diverticulum, Billroth II anatomy) when performing an ”adequate” biliary endoscopic sphincterotomy is technically difficult or impossible and so associated with a higher risk of complications. It is important to note, however, that while current data suggest that the rate of procedure-related pancreatitis appears to be low, the bleeding rate seems to be higher than for standard biliary endoscopic sphincterotomy alone, with rates as high as 8 % - 9 % reported for this complication [11] [16]. In fact, one fatal bleeding complication has been reported in association with this technique [12]. It is not known whether the bleeding is caused by the biliary endoscopic sphincterotomy or by the larger-diameter EPBD, or the the combination of the two methods. Endoscopists should therefore be cautious even when performing large-diameter EPBD alone on an existing (remote) biliary sphincterotomy orifice, particularly in patients with a high risk of bleeding.

Although the currently available data are promising, we believe that further analysis of the safety and efficacy of this technique in a variety of settings (i. e. academic and community practices) is warranted before its use becomes generalized to all endoscopic practices.

Needless to say, doing a ”good” biliary endoscopic sphincterotomy remains critical for the success of this alternative technique. Mechanical lithotripsy or other lithotripsy techniques might still need to be used as a ”rescue” therapy for this ”rescue” technique. In the future, with the expected widespread use of this technique, endoscopists in tertiary referral endoscopic retrograde cholangiopancreatography centers will probably be dealing with a complex group of patients with truly difficult bile duct stones.

Competing interests: None

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References

  • 1 Staritz M, Ewe K, Meyer zum Bueschenfelde K H. Endoscopic papillary dilatation, a possible alternative to endoscopic papillotomy.  Lancet. 1982;  1 1306-1307
    PubMedSearch in Google Scholar
  • 2 DiSario J A, Freeman M, Bjorkman D. et al . Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones.  Gastroenterology. 2004;  127 1291-1299
    CrossrefPubMedSearch in Google Scholar
  • 3 Baron T, Harewood G C. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile duct stones during ERCP: a meta-analysis of randomized controlled trials.  Am J Gastroenterol. 2004;  99 1455-1460
    CrossrefPubMedSearch in Google Scholar
  • 4 Weinberg B M, Shindy W, Lo S. Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones.  Cochrane Database Syst Rev. 2006;  18 CD004890
    PubMedSearch in Google Scholar
  • 5 Bergman J J, Rauws J, Fockens P. et al . Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bile duct stones.  Lancet. 1997;  349 1124-1129
    CrossrefPubMedSearch in Google Scholar
  • 6 Arnold J C, Benz C, Martin W R. et al . Endoscopic papillary balloon dilation vs. sphincterotomy for removal of common bile duct stones: a prospective randomized pilot study.  Endoscopy. 2001;  33 563-567
    Thieme ConnectPubMedSearch in Google Scholar
  • 7 Yasuda I, Tomita E, Enya M. et al . Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function?.  Gut. 2001;  49 686-691
    CrossrefPubMedSearch in Google Scholar
  • 8 Tsujino T, Kawabe T, KomatsuY . et al . Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients.  Clin Gastroenterol Hepatol. 2007;  5 130-137
    CrossrefPubMedSearch in Google Scholar
  • 9 McHenry L, Lehman G. Difficult bile duct stones.  Curr Treat Options Gastroenterol. 2006;  9 123-132
    CrossrefPubMedSearch in Google Scholar
  • 10 Sorbi D, Van Os E C, Aberger F J. et al . Clinical application of a new disposable lithotripter: a prospective multicenter study.  Gastrointest Endosc. 1999;  49 210-213
    PubMedSearch in Google Scholar
  • 11 Ersoz G, Tekesin O, Ozutemiz A O. et al . Biliary sphincterotomy plus dilation with a large balloon for bile duct stones that are difficult to extract.  Gastrointest Endosc. 2003;  57 156-159
    CrossrefPubMedSearch in Google Scholar
  • 12 Yoo B, Kim J, Jung J. et al . Large-balloon sphincteroplasty along with or without sphincterotomy in patients with large extrahepatic bile duct stones: a multicenter study [abstract].  Gastrointest Endosc. 2007;  65 AB97
    PubMedSearch in Google Scholar
  • 13 Attasaranya S, Cheon Y K, McHenry L. et al . Large-diameter papillary balloon dilation to aid in endoscopic bile duct stone removal: a multicenter series [abstract].  Gastrointest Endosc. 2007;  65 AB214
    PubMedSearch in Google Scholar
  • 14 Minami A, Hirose S, Nomoto T. et al . Small sphincterotomy combined with papillary dilation with large balloon permits retrieval of large stones without mechanical lithotripsy.  World J Gastroenterol. 2007;  13 2179-2182
    CrossrefPubMedSearch in Google Scholar
  • 15 Espinel J, Pinedo E, Olcoz J L. Large hydrostatic balloon for choledocholithiasis.  Rev Esp Enferm Dig. 2007;  99 33-38
    PubMedSearch in Google Scholar
  • 16 Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones.  Endoscopy. 2007;  11 958;-961
    PubMedSearch in Google Scholar
  • 17 Aizawa T, Ueno N. Stent placement in the pancreatic duct prevents pancreatitis after endoscopic sphincter dilation for removal of bile duct stones.  Gastrointest Endosc. 2001;  54 209-213
    CrossrefPubMedSearch in Google Scholar

S. Sherman, MD

Division of Gastroenterology/Hepatology

Department of Medicine

Indiana University Medical Center

550 N. University Blvd, Suite 4100

Indianapolis

Indiana 46202

USA

Fax: +1-317-278-0164

Email: ssherman@iupui.edu

#

References

  • 1 Staritz M, Ewe K, Meyer zum Bueschenfelde K H. Endoscopic papillary dilatation, a possible alternative to endoscopic papillotomy.  Lancet. 1982;  1 1306-1307
    PubMedSearch in Google Scholar
  • 2 DiSario J A, Freeman M, Bjorkman D. et al . Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones.  Gastroenterology. 2004;  127 1291-1299
    CrossrefPubMedSearch in Google Scholar
  • 3 Baron T, Harewood G C. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile duct stones during ERCP: a meta-analysis of randomized controlled trials.  Am J Gastroenterol. 2004;  99 1455-1460
    CrossrefPubMedSearch in Google Scholar
  • 4 Weinberg B M, Shindy W, Lo S. Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones.  Cochrane Database Syst Rev. 2006;  18 CD004890
    PubMedSearch in Google Scholar
  • 5 Bergman J J, Rauws J, Fockens P. et al . Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bile duct stones.  Lancet. 1997;  349 1124-1129
    CrossrefPubMedSearch in Google Scholar
  • 6 Arnold J C, Benz C, Martin W R. et al . Endoscopic papillary balloon dilation vs. sphincterotomy for removal of common bile duct stones: a prospective randomized pilot study.  Endoscopy. 2001;  33 563-567
    Thieme ConnectPubMedSearch in Google Scholar
  • 7 Yasuda I, Tomita E, Enya M. et al . Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function?.  Gut. 2001;  49 686-691
    CrossrefPubMedSearch in Google Scholar
  • 8 Tsujino T, Kawabe T, KomatsuY . et al . Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients.  Clin Gastroenterol Hepatol. 2007;  5 130-137
    CrossrefPubMedSearch in Google Scholar
  • 9 McHenry L, Lehman G. Difficult bile duct stones.  Curr Treat Options Gastroenterol. 2006;  9 123-132
    CrossrefPubMedSearch in Google Scholar
  • 10 Sorbi D, Van Os E C, Aberger F J. et al . Clinical application of a new disposable lithotripter: a prospective multicenter study.  Gastrointest Endosc. 1999;  49 210-213
    PubMedSearch in Google Scholar
  • 11 Ersoz G, Tekesin O, Ozutemiz A O. et al . Biliary sphincterotomy plus dilation with a large balloon for bile duct stones that are difficult to extract.  Gastrointest Endosc. 2003;  57 156-159
    CrossrefPubMedSearch in Google Scholar
  • 12 Yoo B, Kim J, Jung J. et al . Large-balloon sphincteroplasty along with or without sphincterotomy in patients with large extrahepatic bile duct stones: a multicenter study [abstract].  Gastrointest Endosc. 2007;  65 AB97
    PubMedSearch in Google Scholar
  • 13 Attasaranya S, Cheon Y K, McHenry L. et al . Large-diameter papillary balloon dilation to aid in endoscopic bile duct stone removal: a multicenter series [abstract].  Gastrointest Endosc. 2007;  65 AB214
    PubMedSearch in Google Scholar
  • 14 Minami A, Hirose S, Nomoto T. et al . Small sphincterotomy combined with papillary dilation with large balloon permits retrieval of large stones without mechanical lithotripsy.  World J Gastroenterol. 2007;  13 2179-2182
    CrossrefPubMedSearch in Google Scholar
  • 15 Espinel J, Pinedo E, Olcoz J L. Large hydrostatic balloon for choledocholithiasis.  Rev Esp Enferm Dig. 2007;  99 33-38
    PubMedSearch in Google Scholar
  • 16 Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones.  Endoscopy. 2007;  11 958;-961
    PubMedSearch in Google Scholar
  • 17 Aizawa T, Ueno N. Stent placement in the pancreatic duct prevents pancreatitis after endoscopic sphincter dilation for removal of bile duct stones.  Gastrointest Endosc. 2001;  54 209-213
    CrossrefPubMedSearch in Google Scholar

S. Sherman, MD

Division of Gastroenterology/Hepatology

Department of Medicine

Indiana University Medical Center

550 N. University Blvd, Suite 4100

Indianapolis

Indiana 46202

USA

Fax: +1-317-278-0164

Email: ssherman@iupui.edu

   Permissions and Reprints