’Original article Innovative percutaneous antegrade clearance of intrahepatic and extrahepatic biliary stones with the use of a hysterosalpingography catheter Lorenzo Patronea,b, Aneeta Parthipuna, Athanasios Diamantopoulosa, Francesco Pinnab, Alessandro Valdatab, Irfan Ahmeda, Marco Filaurob, Tarun Sabharwala and Giovanni de Carob Objectives We present a novel modified technique of percutaneous antegrade clearance of intrahepatic and common bile duct stones with the use of a hysterosalpingography balloon (HSG) catheter. Methods Technical tips and techniques used, along with the clinical results obtained in six patients whom we treated over a 6-month period have been described. Results The HSG balloon catheter is shown to demonstrate superior pushability, flexibility, and maneuverability in comparison with other previously described compliant balloons. Conclusions The HSG balloon catheter is shown to be a really good device to remove intrahepatic and common bile duct stones percutaneously, allowing, where required, access to both the right and the left intrahepatic biliary systems from a single and smaller Fr hepatic bile duct access. Eur J Gastroenterol Hepatol 27:419–424 Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Introduction

Materials and methods

Hepatolithiasis is defined as the presence of gallstones in the intrahepatic biliary ducts, proximal to the left and right hepatic ducts, irrespective of the coexistence of gallstones in the common bile duct (CBD) [1]. The goal of the treatment of hepatolithiasis and CBD lithiasis is to resolve ongoing infections, thereby preventing recurrent cholangitis, subsequent hepatic fibrosis, and, therefore, progression to cholangiocarcinoma. To date, there are several treatment options, which range from surgical treatment to endoscopic or percutaneous techniques. Percutaneous techniques are the only feasible option in cases that are either unsuitable for surgery or in which endoscopic retrograde cholangiopancreatography (ERCP) is contraindicated because of previous abdominal surgery. We present the technique, and technical and immediate clinical results of using a hysterosalpingography balloon (HSG) catheter to percutaneously push calculi from the biliary tract into the bowel for the treatment of intrahepatic and extrahepatic biliary lithiasis.

Patients

European Journal of Gastroenterology & Hepatology 2015, 27:419–424 Keywords: bile ducts, calculi, cholelithiasis, interventional, radiography, radiology a Department of Interventional Radiology, Guy’s and St. Thomas’ NHS Trust, St Thomas’ Hospital, London, UK and bDepartment of Interventional Radiology, Genova, Italy

Correspondence to Lorenzo Patrone, MD, Via Sarfatti 1b/2 16167 Genova, Italy Tel: + 39 392 805 9623; fax: + 39 010 563 2018; e-mail: lorepatro83@hotmail. com Received 14 October 2014 Accepted 6 January 2015

During a 6-month period (July 2013–December 2013), six consecutive patients (six male, mean age 52 years, range 45–81 years) underwent percutaneous clearance of intrahepatic and extrahepatic calculi at two tertiary referral centers. All patients had a history of gastrointestinal surgery; therefore, they were not suitable for ERCP. Three patients (n = 3/6, 50.00%) had bilioenteric anastomoses, following complications secondary to biliary duct injury during laparoscopic cholecystectomy for gallbladder calculi. Two patients (n = 2/6, 33.33%) had undergone a previous gastrojejunostomy (one patient had undergone this procedure following an anastomotic recurrence from a subtotal gastrectomy, whereas the other patient had undergone this operation due to gastric outlet obstruction secondary to recurrent pancreatitis caused by type 4 hyperlipidemia). One patient (n = 1/6, 16.67%) had undergone total gastrectomy for curative gastric carcinoma. A summary of the relevant clinical history of each patient is presented in Table 1. The mean time from previous surgical intervention to referral was 4.5 years (range: 2–12 years). All six patients presented with clinical jaundice, a history of relapsing cholangitis, and laboratory blood investigations that revealed obstructive liver function tests (elevated bilirubin, γ-glutamyl transferase, and alkaline phosphatase levels). Magnetic resonance cholangiopancreatography (MRCP) was performed in all patients, which demonstrated intrahepatic biliary duct dilatation secondary to single or multiple biliary duct calculi (Fig. 1a and b). Due to the previous abdominal surgical history, none of the patients were suitable for ERCP (Table 1), and they were therefore referred to the interventional radiology

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DOI: 10.1097/MEG.0000000000000291

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Fig. 1. (a) MRCP showing massive lithiasis in the common hepatic duct, biliary ducts of segments 3, and 5–8, and also close to the bilioenteric anastomosis (case 6). (b) MRCP showing massive intrahepatic lithiasis and multiple stones at the bilioenteric anastomosis (three calculi in the left hepatic lobe and four calculi in the right hepatic lobe; case 1). (c) Initial cholangiographic images showing a large (13 mm) CBD calculus in the CBD (case 4). (d) The first cholangiographic images (case 1) confirming the MRCP diagnosis of massive intrahepatic lithiasis. CBD, common bile duct; MRCP, magnetic resonance cholangiopancreatography.

department for a percutaneous transhepatic cholangiogram (PTC; Table 1) with the intention to treat. The study was approved by the appropriate institutional ethics committee. Procedure

A written consent form was obtained from each patient. In all cases, a PTC was performed under local anesthesia and

conscious sedation. A single peripheral biliary duct was punctured, and contrast was injected into the biliary tree from an appropriate-sized sheath (sheath size: 6 to 8 Fr; Terumo Corporation, Tokyo, Japan) to confirm the presence of either a single biliary calculus (Fig. 1c) or multiple biliary calculi (Fig. 1d). Following this, using standard catheter techniques, a 0.035 inch Amplatz super-stiff guidewire (Boston Scientific, Marlborough, Massachusetts, USA) was manipulated into the bowel with the assistance of

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HSG catheter for treatment of biliary lithiasis Patrone et al.

a Cobra-shaped catheter (Terumo Corporation). A lowprofile 10 or 12 Fr angioplasty balloon catheter was then inflated at the level of the papilla/anastomosis until its waist disappeared and then deflated and removed carefully to avoid migration of the calculi at the level of the CBD. In three cases in which massive hepatolithiasis was demonstrated on previous MRI imaging (cases 1, 5, and 6), following the establishment of biliary access, selective catheterization of all the intrahepatic biliary ducts containing calculi was performed using the 5 Fr Cobra-shaped catheter and a 0.035 inch standard hydrophilic guidewire (Terumo Corporation). The Cobra-shaped catheter was replaced with a 5.5 Fr HSG catheter, advanced over the same wire, for every biliary duct catheterized. After balloon inflation, the compliant balloon catheter was scrolled along the guidewire, dragging the calculi from the intrahepatic biliary ducts into the CBD (Fig. 3a and b). In the other three patients (cases 2, 3, and 4), following establishment of biliary access, cholangiographic images only demonstrated CBD calculi. Therefore, selective catheterization of the intrahepatic ducts was not required. In all six patients, the calculi were then pushed from the CBD into the duodenum through the dilated anastomosis using the HSG catheter. At the end of the procedure, an 8 Fr internal–external drain was placed in the CBD for 1–6 days. Instructions were given to the medical team to ensure that the drain was flushed four times a day with a 0.9% sodium chloride solution to ensure access patency and to decompress the biliary tree. The HSG catheter (Angiotech, PBN Medicals, Stenlose, Denmark) is a 40 cm catheter made by Pebax, which is available in 5.5 and 7 Fr diameters, with a soft, nontraumatic, compliant balloon that is either 10 or 15 mm, composed of Kraton (Fig. 2a and b). It is radiopaque and sufficiently stiff to obtain adequate pushability, but it also has excellent flexibility. The soft rounded tip of the balloon catheter is made of polyurethane. This feature reduces tissue irritation and postoperative stenotic risk. During the procedures, air inflation of the HSG balloon was observed to be particularly useful (rather than diluted contrast), enabling better visualization of the balloon in the presence of concentrated biliary contrast (Fig. 3a).

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In five cases (n = 5/6, 83.33%) a 5.5 Fr HSG catheter (balloon diameter = 10 mm) was used, whereas in one case (n = 1/6, 16.67%; case 4) a 7 Fr HSG catheter (balloon diameter = 13 mm) was required because of a large solitary CBD calculus (Fig. 1c). The overall technical success was 100% (n = 6/6), with complete resolution of the lithiasis achieved in all patients (Fig. 3c and d). In four cases (n = 4/6, 66.67%), the final cholangiographic images demonstrated total resolution of the biliary tree lithiasis (primary technical success: 66.67%, n = 4/6). In the remaining two patients (n = 2/6, 33.33%; cases 1 and 6), a second procedure was necessary to remove residual biliary calculi evident on subsequent follow-up cholangiographic studies (secondary technical success: 100.0%, n = 6/6). In one of these cases (case 1), the same right side biliary access was used to remove intrahepatic calculi from both the right and left hepatic ducts. However, in the other patient (case 6), a second biliary duct access was performed from the contralateral hemisystem. In this particular case, it was not feasible to access the calculi from the initial access site due to steep angulation of the intrahepatic ducts. Complete clinical success was achieved in six patients (n = 5/6, 83.33%). There were no immediate (initial 24 h after the procedure) complications (n = 0/6, 0.0%). In one case (n = 1/6, 16.7%; case 2), a check cholangiogram obtained 24 h after the initial procedure confirmed satisfactory clearance of the biliary calculi with patency of the biliary ducts. Therefore, the internal–external biliary drain was removed. Unfortunately, however, the patient developed biliary sepsis 8 h after removal of the internal–external biliary drain. Hence, a repeat PTC was performed, which confirmed no residual lithiasis, and the patient was treated for sepsis with antibiotics. In one patient (n = 1/6, 16.7%; case 3), a check cholangiogram showed small residual calculi in the cystic duct, and therefore a 10 × 70 mm Wallstent stent was inserted into the CBD across the papilla of Vater to maintain biliary patency and thereby avoid cholecystectomy. The overall 30-day mortality was zero (n = 0/6, 0.0%). Discussion

Results

Overall technical success was defined as successful removal of the obstructing biliary calculi with no immediate procedural complications. Primary technical success included all cases that needed no further intervention, whereas secondary technical success included cases that required a subsequent follow-up procedure to remove residual calculi. Clinical success was defined as postprocedural relief from obstructive symptoms, in combination with normalization of liver function tests.

Fig. 2. (a) A 5 Fr HSG catheter (Angiotech, PBN Medicals). (b) Magnified view of the 10 mm compliant balloon tip made of Kraton. HSG, hysterosalpingography.

ERCP is currently the standard method for removal of extrahepatic bile duct stones, although it could be unsuccessful due to a difficult anatomy, previous surgery, periampullary diverticula, and the presence of a large stone [2]. However, hepatectomy is the most definitive treatment option for intrahepatic biliary lithiasis, as it enables the removal of calculi and simultaneous removal of underlying pathological biliary ducts [3–5]. However, the indications for hepatectomy need to be carefully considered. Traditionally, hepatectomy has been used when intrahepatic strictures are limited to either one lobe or segment [6]. Other surgical options include choledochoenterostomy and T-tube drainage. In some cases, surgical treatment may not be an option (e.g. in patients with a high anesthetic risk, patients who decline surgical intervention, those with a history of previous biliary surgery, or patients with multiple biliary calculi involving several intrahepatic ducts).

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Fig. 3. (a) Air was used to inflate the HSG balloon to enable visualization of the balloon against the contrast-filled biliary ducts in case 6. (b) A 5 Fr HSG catheter (indicated by a black arrow) passes over the hydrophilic guidewire in the right intrahepatic duct and in the branch for the VIII segment to push the stones into the duodenum from the VI segment access in case 1. In (c) case 6 and (d) case 1, the final cholangiogram showed no biliary calculi. HSG, hysterosalpingography.

Nonsurgical options have comparable efficacy to surgical resection in terms of clearance of intrahepatic calculi. However, such cases carry a higher relapse rate [5,7]. These nonsurgical approaches include endoscopic and/or radiological procedures. Endoscopic treatment, such as balloon-enteroscopy-assisted ERCP, is relatively safe; however, this approach is suboptimal for the treatment of intrahepatic lithiasis due to duct angulation, degree of stone impaction, small caliber of the secondary degree branches, and also the presence of biliary strictures [5,8,9]. Percutaneous antegrade expulsion of bile stones into the duodenum over a dilated papilla was initially described by

Meranze et al. [10], Muchart et al. [11], and Gil et al. [12] and then reported by others [2,13,14] in large series of patients. This technique is considered to be safe and effective: maintenance of the anatomic integrity and function of the sphincter is desirable, resulting in a great advantage compared with other treatment techniques, such as endoscopic papillotomy or surgery. Using a 12-mm diameter balloon for papilloplasty to push calculi of up to 15 mm through the papilla is, in our opinion, acceptable, as reported by García-García and Lanciego [2]. There are many other advantages of this technique compared with the equivalent endoscopic treatment: the

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Case 4

Case 5

Case 6

CBD, common bile duct; MRCP, magnetic resonance cholangiopancreatography; PTC, percutaneous transhepatic cholangiogram.

Day 5 – PTC through contralateral access for clearance of residual biliary calculi Day 10 – complete stone clearance observed on the check cholangiogram MRCP – multiple stones at the bilioenteric anastomosis (three calculi in the left hepatic lobe and four in the right, each 10 mm)

Day 3 – complete stone clearance observed on the check cholangiogram

Day 3 – complete stone clearance observed on the check cholangiogram

Postextracorporeal shockwave lithotripsy. MRCP – multiple stone fragments within the supracystic and common hepatic ducts, and a 13 mm common bile duct calculus MRCP – biliary lithiasis involving the left and right biliary ducts

MRCP – stricture of the CBD at the level of the pancreatic head with distal CBD calculus and segment 6 calculus 55 Case 3

Gastrojejunostomy (due to gastric outflow obstruction) secondary to chronic pancreatitis caused by type 4 hyperlipidemia Total gastrectomy for gastric carcinoma. After 7 years, extracorporeal shockwave lithotripsy for a single common bile duct stone Gallbladder empyema treated with cholecystectomy and bilioenteric anastomosis (due to CBD injury during elective laparoscopic cholecystectomy) Cholecystectomy for gallbladder calculi. External biliary fistula formation treated with bilioenteric anastomosis (2001)

57 Case 2

Subtotal gastrectomy for gastric carcinoma. Anastomotic recurrence (2 years later) treated with gastrojejunostomy and biliary bypass

Day 3 – same access used for residual biliary calculi balloon clearance

MRCP – intrahepatic biliary duct dilatation with calculi in the intrahepatic confluence, common hepatic duct, segment 3, 5, 6, 7, 8 ducts, and close to bilioenteric anastomosis MRCP – two distal CBD calculi 66 Case 1

Cholecystectomy and bilioenteric anastomosis for biliary calculi

Results/complications Imaging findings Previous surgery Age

Table 1. Patient characteristics

The PTC was removed after 1 day, following review of check cholangiographic images by the clinicians (due to satisfactory stone clearance and patency of the ampulla of Vater). The patient was due for an elective cholecystectomy at 14 days; however, the patient developed interim sepsis and required a new PTC 8 h after removal of the initial PTC. No residual biliary calculi were seen on the repeat PTC Day 3 – the check cholangiogram showed residual calculi in the cystic duct, and therefore a CBD Wallstent stent was inserted

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procedure is in the direction of the bile flow, kinking of the guidewire is avoided, better positioning of the balloon is achieved in the middle of the papilla, and favorable angles are achieved to better transmit the force necessary for expulsion. The sheath can also be used to administer contrast material, prevent air bubbles, and avoid tract injury [2]. The access to the bile duct permits repetition of the expulsion maneuver as many times as necessary, and having the bile duct with external drainage in position for several days reduces the risk for manipulation-induced cholangitis by precluding sphincter spasm and providing an egress route for infected bile [2,14]. The presence of an internal–external biliary catheter after the procedure enables the option of repeated cholangiography, which may be necessary, for example, if the biliary function deteriorates. This also allows for subsequent treatments and repeat trawling if necessary. Flushing the drain twice a day helps clear the bile from sludge, clots, and calculi sand. All these advantages are supported by a very low rate of acute pancreatitis and cholangitis [14]. Another merit of this procedure is its simplicity. Several calculi can be pushed through the biliary ducts into the duodenum in a single attempt, often through a single biliary access (either the right or the left lobe of the liver). Other percutaneous techniques have been described: high success rates (95%) and low incidence of complications (4%) have been demonstrated with the transhepatic use of the Dormia basket [14,15]. However, it requires a larger tract diameter and should be avoided for at least 4–6 weeks for maturation of the transhepatic tract [15]. Because of this, the major advantage of balloon dilation of the papilla using of a compliant balloon for clearance of bile duct calculi (as described by Gil et al. [12]) is that a significantly smaller tract is required. In addition, it is associated with reduced hospitalization, 3–4 days after the procedure, thereby resulting in hospital cost saving [13]. We hereby report our experience with the use of an HSG catheter with a compliant, Kraton balloon tip to push calculi percutaneously from the biliary tree to the duodenum. There are several advantages of the design of the HSG catheter in comparison with the previously described occlusion balloons reported in the literature [2,12–14]. The largest available HSG balloon is 15 mm in size. This is significantly larger than the maximum size of the currently described occlusion balloons (occlusion balloon; Boston Scientific, Medi-Tech, Boston, Massachusetts, USA; ThruLumen Embolectomy Catheter; Edwards Lifesciences, Irvine, California, USA). For this key reason, it is particularly useful to capture and push biliary calculi into the duodenum, as demonstrated in case 4 (Fig. 1c). Other beneficial features of the HSG catheter are the shorter length (only 40 cm) and the high stiffness of the catheter, which allow for higher maneuverability through angulated biliary ducts and increased pushability. These two features allow it to be used either through right lobe or through left lobe hepatic duct access to treat contralateral lobe intrahepatic biliary calculi (Fig. 3a and b). The short length of the HSG catheter can also pose a limitation, as it may be inadequate to reach every contralateral distal biliary duct. This may be especially problematic in patients with hepatomegaly, long common

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biliary ducts, and very peripheral percutaneous access. In such cases, bilateral access may be required. Although this study includes only six cases, our experience with the use of this catheter demonstrates high technical success and a low complication rate, which correlate well with other published series [2,12–14]. Other limitations of our study include the lack of a control cohort and nonrandomization. Conclusion

The transhepatic treatment approach to intrahepatic and extrahepatic biliary lithiasis using an HSG catheter is a relatively safe, nontraumatic, and effective treatment option. It represents an excellent alternative to the previously described occlusion balloon for trawling of biliary calculi into the duodenum. The fundamental attractive features of the HSG catheter compared with the occlusion balloon are the shorter shaft, increased flexibility, higher maneuverability, and high pushability.

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There are no conflicts of interest. 13

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Innovative percutaneous antegrade clearance of intrahepatic and extrahepatic biliary stones with the use of a hysterosalpingography catheter.

We present a novel modified technique of percutaneous antegrade clearance of intrahepatic and common bile duct stones with the use of a hysterosalping...
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