Dig Dis Sci DOI 10.1007/s10620-014-3154-y

ORIGINAL ARTICLE

Endoscopic Balloon Dilation Lithotripsy for Difficult Bile Duct Stones Jin-Seok Park • Seok Jeong • Jee Young Han Don Haeng Lee



Received: 9 February 2014 / Accepted: 3 April 2014 Ó Springer Science+Business Media New York 2014

Abstract Background/Aim Endoscopic treatment for removal of large or impacted bile duct stones is challenging, and may not be successful. The aim of this study was to evaluate the safety and efficacy of endoscopic balloon dilation lithotripsy (EBDL) as a means of treating difficult extrahepatic bile duct stones refractory to failed conventional endoscopic treatments. Patients and Methods The patients were included in the indication of EBDL only if stones were confirmed as brown-pigmented stones or recurrent. Balloon dilation was performed using a balloon dilation catheter in order to crush large and/or impacted stones at the common hepatic duct or common bile duct level in seven cases, and then fragmented stones were removed using a basket and/or an extraction balloon catheter. Results The median diameter of the balloons used for EBDL was 32.4 ± 10.5 mm (range, 12.4–52.1). Balloon dilation was performed for 60 s per session. The mean number of EBDL sessions required to crush stones was two (range, 1–5), the mean number of ERCP sessions required for complete stone removal was 2.4 ± 0.8 (range, 1–3), the J.-S. Park  S. Jeong (&)  J. Y. Han  D. H. Lee Department of Internal Medicine, Digestive Disease Center, Inha University School of Medicine, 27 Inhang-ro, Jung-gu, Incheon 400-711, Republic of Korea e-mail: [email protected] S. Jeong  D. H. Lee National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Republic of Korea D. H. Lee Utah-Inha DDS and Advanced Therapeutics Research Center, Incheon, Republic of Korea

overall procedure-related complication rate was 0 % (0/7), and the success rate was 100 % (7/7). Conclusion EBDL might be a safe and effective option for the treatment of large and impacted extrahepatic bile duct stones refractory to conventional endoscopic treatments. Keywords

Lithotripsy  Balloon  Choledocholithiasis

Introduction The endoscopic treatment of bile duct stones is commonly performed worldwide and has a success rate of 90 % [1]. However, approximately 10–15 % of patients present with bile duct stones that are difficult to remove using standard techniques. These stones are generally larger than 1.5 cm, impacted, located proximal to biliary structures, or associated with duodenal diverticulum, and are removed by mechanical lithotripsy (ML) or endoscopic papillary large balloon dilation (EPLBD) [2]. However, these techniques may not be effective for the removal of certain large, impacted common bile duct (CBD) stones. Here, we describe the use of endoscopic balloon dilation lithotripsy (EBDL) for the retrieval of stones in seven patients with difficult stones in whom conventional endoscopic treatments failed.

Case Series Patients The medical records and endoscopic data of patients that underwent EBDL between January 2012 and December

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Fig. 1 a Cholangiogram showing large stones impacted in a dilated common bile duct (CBD). b Endoscopic balloon dilation lithotripsy (EBDL) was performed using a balloon dilation catheter of diameter

12 mm. c After EBDL, large stones were fragmented within the bile duct. d The stone fragments were completely removed using a basket and an extraction balloon catheter

2013 in our hospital were retrospectively reviewed. The inclusion criteria applied were: (1) large CBD stones (diameter C 20 mm) and/or impacted stones, (2) dilated CBD (CBD diameter C 10 mm), (3) brown pigmented stones, and (4) a failure to retrieve a stone by ML and EPLBD. The study protocol was approved by the Institutional Review Board of our institution (IUH-IRB 14-003).

determined fluoroscopically) and then maintained for 60 s to crush the CBD stone. Selected inflation diameters were smaller than the diameter of the distal CBD. EBDL was performed repeatedly until the targeted stones were crushed into small fragments, which were then removed with a basket and/or an extraction balloon catheter. Even if stones were not crushed well, EBDL was not performed more than twice per session to prevent complications. When bile duct stone removal was unsuccessful in the first sessions, a biliary plastic stent or nasobiliary drainage catheter was placed to ensure biliary drainage before the procedure was terminated. These patients underwent a second session of EBDL and conventional ERCP 2 or 3 days later. Complete stone clearance was confirmed by balloon occlusion cholangiography after stone removal. EBDL was conducted by one dedicated endoscopist (S.J.) with experience of more than 7,000 ERCP procedures.

Endoscopic Balloon Dilation Lithotripsy Endoscopic retrograde cholangiopancreatography (ERCP) was performed using a standard side viewing duodenoscope (TJF; Olympus Medical, Tokyo, Japan). Patients were treated under conscious diazepam sedation. When a large or impacted bile duct stone was visualized by cholangiography, ML was tried using a standard technique. In the majority of cases, bile duct stones were removed using mechanical lithotripter (Trapezoid RX Lithotripter Compatible Basket; Boston Scientific, Natick, Mass) or LithoCrushV Mechanical Lithotriptor (Olympus Medical). However, when a large or impacted stone could not be captured and fragmented using a mechanical lithotripter, EBDL was performed as follows (Fig. 1). A balloon dilation catheter (CRE; Boston Scientific) was placed next to the stone, and the balloon was inflated with diluted contrast medium until it reached a diameter of 10–12 mm (as

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Measurement of Outcomes Primary outcome was the success rate of complete CBD clearance by EBDL in patients with difficult CBD stones. Secondary outcomes were as follows: (1) any adverse events related to EBDL, such as, bleeding, perforation, pancreatitis, or cholangitis, and (2) the number of ERCP sessions required to achieve complete CBD stone removal.

Dig Dis Sci Table 1 Baseline characteristics of patients and CBD stones

Patient number

Sex

1

M

90

1

Brown

39

34.9

Large stone

Recurrent

2

F

76

2

Brown

21.6

33

Large and impacted stone

Recurrent

3

M

53

2

Brown

52.1

52.1

Large and impacted stone

Recurrent

4

F

70

2

Brown

39.8

29.5

Large and impacted stone

Recurrent

5

M

84

1

Brown

14.2

21.1

Impacted stone

Naı¨ve

6

F

89

3

Brown

35

35

Naı¨ve

M male, F female, CBD common bile duct, EBDL endoscopic balloon dilation lithotripsy

Large and impacted stone

7

M

67

1

Brown

15.4

21.2

Impacted stone

Recurrent

Table 2 Clinical outcomes of EBDL

Patient number

Balloon diameter (mm)

Number of session (EBDL)

Number of session (ERCP)

Achievement of complete CBD clearance

Adverse event

1

12

2

3

Yes

No

2

10

2

3

Yes

No

3 4

12 10

5 1

3 3

Yes Yes

No No

5

12

1

2

Yes

No

6

12

1

2

Yes

No

7

10

2

1

Yes

No

EBDL endoscopic balloon dilation lithotripsy, ERCP endoscopic retrograde cholangiopancreatography, CBD common bile duct stone

Age (years)

CBD stone number

Bleeding was defined as clinical evidence of bleeding, such as melena or hematemesis, with an associated decrease of 2 g/dL in hemoglobin concentration. Post-ERCP pancreatitis was defined as abdominal pain lasting 24 h after the procedure combined with at least a three-fold increment in the normal upper limit of serum amylase level.

Stone character

Maximum CBD diameter (mm)

CBD stone diameter (mm)

Reason for EBDL

Nature of CBD stones

sessions required to crush CBD stones was 2 (range, 1–5), and the mean number of ERCP sessions required for complete biliary clearance was 2.4 ± 0.8 (range, 1–3). No significant adverse events, such as perforation, bleeding, pancreatitis, or cholangitis were observed (Table 2).

Discussion Results Between January 2012 and December 2013, seven patients with a large and/or impacted CBD stone were enrolled in the study. All patients underwent EBDL after failure of initial ML. Mean age was 75.5 ± 13.4 years (range, 53–90), and the mean number of stones per patient was 1.7 ± 0.8 (range, 1–3). Mean maximum stone size was 32.4 ± 10.5 mm (range, 21.2–52.1), and mean maximum CBD size was 31 ± 14.2 mm (range, 15.4–52.1 mm). Patient baseline characteristics are summarized in Table 1. Complete CBD clearance was achieved in all seven patients that underwent EBDL. The mean number of EBDL

Large bile duct stones, particularly those with a diameter exceeding 2 cm, require fragmentation before removal to reduce the risk of stone impaction [3]. ML is the most common technique and a standard option in all ERCP units, and its success rate for bile duct stone fragmentation is better than 90 % without serious adverse events. However, the success rate decreases under certain conditions [4]. In particular, ML failure is mainly associated with stone diameter, stone impaction in the bile duct, or failure to capture stones with a basket [5]. In such cases, fragmentation is required to achieve stone removal. Other endoscopic lithotripsy techniques that are used to fragment

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difficult bile duct stones include electrohydraulic lithotripsy, laser lithotripsy, and extracorporeal shock wave lithotripsy, but these techniques require specialized equipment that is not universally available, such as peroral cholangioscopy using an ultra-slim upper endoscope or SpyGlass and mother-baby scope. This situation existed in our institution, and thus, EBDL was selected for the removal of difficult CBD stones rather than endoscopic lithotripsy. Patients in the present study may have been treated using other endoscopic lithotripsy techniques, but in all patients, difficult CBD stones were removed successfully by EBDL. Furthermore, the costs of these procedures are much higher than that of ML [6]. Surgical or percutaneous removal of difficult stones offers another effective treatment method. However, invasive methods can result in serious adverse events, and they are associated with longer recovery and preparatory times. Accordingly, we consider that EBDL offers an attractive means of resolving these problems and several advantages. First, EBDL is a simple procedure that is readily available. EBDL is similar to endoscopic papillary balloon dilation (EPBD), except that balloon dilation is performed at the target stone instead of the papilla. In fact, EPBD is widely used to remove bile duct stones and is not difficult to perform [7]. In the present study, all EBDL sessions undertaken to remove difficult CBD stones that were not captured with a mechanical lithotripter were successful, and no technical difficulties were reported. Second, the procedure is probably costeffective, because EBDL does not require additional devices, like those required by other endoscopic treatment options, such as electrohydraulic lithotripsy, laser lithotripsy, or extracorporeal shock wave lithotripsy. Therefore, EBDL can be used to remove difficult bile duct stones in hospitals that lack specialized equipment at relatively low cost to patients. However, we did not compare EBDL to therapeutic methods that do not require specialized equipment, such as the placement of multiple plastic stents for 2–3 months. The third advantage is the efficacy of this procedure. In the present study, despite the presence of stones larger than 2 cm in diameter and impacted stones in four of the seven patients, EBDL was used successfully in all cases without any adverse events. Despite these advantages and the satisfactory results obtained in the present study, the possibility of bile duct injury occurring during the procedure is a concern, as it is in EPBD. We presume that harder stones are associated with a greater risk of bile duct injury because EBDL

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requires that the stone be pressed against the bile duct wall. Therefore, the indications for EBDL should be limited to brown-pigmented stones with a lower degree of hardness. The determination of the characteristics of target stones before deciding to perform EBDL is performed by observing stone fragments removed endoscopically from the CBD during conventional ERCP or by assessing recurrent stones. In addition, caution should be exercised to prevent bile duct injury by EBDL. We inflated the balloon gradually and assessed potential damage to the bile duct and degree of stone fragmentation every 30 s. In addition, we did not attempt to achieve complete CBD clearance in one session. During a single session of ERCP, EBDL was not performed more than twice, and if stones were not well crushed, EBDL was repeated within 3 days. Furthermore, we believe that this cautious approach explains the zero rate of adverse events encountered in the present study. We conclude that EBDL could be a safe and effective alternative for the treatment of large and impacted extrahepatic bile duct stones with a slightly dilated common hepatic or intrahepatic duct refractory to conventional endoscopic treatment. Acknowledgment The current study was supported by Inha University Research Grant. Conflict of interest

None.

References 1. Cipolletta L, Costamagna G, Bianco MA, et al. Endoscopic mechanical lithotripsy of difficult common bile duct stones. Br J Surg. 1997;84:1407–1409. 2. Prachayakul V, Aswakul P, Kachintorn U. Electrohydraulic lithotripsy as an highly effective method for complete large common bile duct stone clearance. J Interv Gastroenterol. 2013;3:59–63. 3. Trikudanathan G, Navaneethan U, Parsi MA. Endoscopic management of difficult common bile duct stones. World J Gastroenterol. 2013;19:165–173. 4. Schneider MU, Matek W, Bauer R, Domschke W. Mechanical lithotripsy of bile duct stones in 209 patients—effect of technical advances. Endoscopy. 1988;20:248–253. 5. Garg PK, Tandon RK, Ahuja V, Makharia GK, Batra Y. Predictors of unsuccessful mechanical lithotripsy and endoscopic clearance of large bile duct stones. Gastrointest Endosc. 2004;59:601–605. 6. Stefanidis G, Christodoulou C, Manolakopoulos S, Chuttani R. Endoscopic extraction of large common bile duct stones: a review article. World J Gastroinest Endosc. 2012;4:167–179. 7. Seo YR, Moon JH, Choi HJ, et al. Comparison of endoscopic papillary balloon dilation and sphincterotomy in young patients with CBD stones and gallstones. Dig Dis Sci. Epub. 11/2013.

Endoscopic balloon dilation lithotripsy for difficult bile duct stones.

Endoscopic treatment for removal of large or impacted bile duct stones is challenging, and may not be successful. The aim of this study was to evaluat...
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