Cardiovasc Intervent Radiol DOI 10.1007/s00270-014-0836-y

CLINICAL INVESTIGATION

Percutaneous Balloon Dilatation and Long-Term Drainage as Treatment of Anastomotic and Nonanastomotic Benign Biliary Strictures Jan Jaap Janssen • Otto M. van Delden • Krijn P. van Lienden • Erik A. J. Rauws • Olivier R. C. Busch • Thomas M. van Gulik • Dirk J. Gouma • Johan S. Lame´ris

Received: 30 May 2013 / Accepted: 27 December 2013 Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2014

Abstract Purpose This study was designed to determine the effectiveness of percutaneous balloon dilation and longterm drainage of postoperative benign biliary strictures. Methods Medical records of patients with postoperative benign biliary strictures, in whom percutaneous transhepatic biliary drainage (PTBD) and balloon dilation was performed between January 1999 and December 2011, were retrospectively reviewed. PTBD and balloon dilation (4–10 mm) were followed by placement of internal-external biliary drainage catheters (8.5–12 F). Patients were scheduled for elective tube changes, if necessary combined with repeated balloon dilation of the stenosis, at 3-week intervals up to a minimum of 3 months.

Results Ninety-eight patients received a total of 134 treatments. The treatment was considered technically successful in 98.5 %. Drainage catheters were left in with a median duration of 14 weeks. Complications occurred in 11 patients. In 13 patients, percutaneous treatment was converted to surgical intervention. Of 85 patients in whom percutaneous treatment was completed, 11.8 % developed clinically relevant restenosis. Median follow-up was 35 months. Probability of patency at 1, 2, 5, and 10 years was 0.95, 0.92, 0.88, and 0.72, respectively. Overall, 76.5 % had successful management with PTBD. Restenosis and treatment failure occurred more often in patients who underwent multiple treatments. Treatments failed more often in patients with multiple strictures. All blood markers of liver function significantly decreased to normal values.

J. J. Janssen (&)  O. M. van Delden Department of Radiology, Room G1-212, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands e-mail: [email protected]

T. M. van Gulik Department of Surgery, Room IWOA1-119, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands e-mail: [email protected]

O. M. van Delden e-mail: [email protected] K. P. van Lienden Department of Radiology, Room G1-229, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands e-mail: [email protected] E. A. J. Rauws Department of Gastroenterology, Room C2-327, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands e-mail: [email protected]

D. J. Gouma Department of Surgery, Room G4-116, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands e-mail: [email protected] J. S. Lame´ris Department of Radiology, Room G1-207, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands e-mail: [email protected]

O. R. C. Busch Department of Surgery, Room G4-113, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands e-mail: [email protected]

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J. J. Janssen et al.: Percutaneous Treatment of Benign Biliary Strictures

Conclusions Percutaneous balloon dilation and long-term drainage demonstrate good short- and long-term effectiveness as treatment for postoperative benign biliary strictures with an acceptably low complication rate and therefore are indicated as treatment of choice. Keywords Non-vascular interventions  Dilation  Drainage  Stenting/stent graft/drug eluting stents  Bile duct/gallbladder/biliary  Stenosis/restenosis

Introduction Management of benign biliary strictures is challenging. If untreated, bile duct strictures can lead to cholangitis, portal hypertension, and finally, in some patients, liver cirrhosis. Regardless of the cause, the treatment of benign biliary strictures is aimed at reestablishing an unimpeded bile flow. There is still controversy about the various treatment options, including surgery, endoscopic therapy, and percutaneous transhepatic approaches [1–3]. Until recently, surgical hepaticojejunostomy (HJ), with a clinical success rate of 80–90 % [1–3] and a chance at restenosis of 10–30 % [4, 5], was considered as the treatment of choice for benign biliary strictures, especially in primary strictures [6]. In postoperative strictures, surgical management is technically more difficult, particularly when the remaining extrahepatic bile duct is short or absent. Inflammation or dense fibrosis may further complicate surgery. Endoscopic treatment has been used increasingly over the past decade for the management of benign biliary strictures, both anastomotic and nonanastomotic. In postcholecystectomy patients, the success rate ranges from 74–90 %, wherein distal strictures (Bismuth I and II) are associated with a better success rate than proximal hilar strictures (Bismuth III). The chance of restenosis within 2 years after stent removal is 20–30 % [7–9]. The use of percutaneous transhepatic biliary drainage (PTBD) and balloon dilation was first reported as treatment of biliary strictures in 1978 by Molnar and Stockum [10]. At present, PTBD is mostly used in patients with stenosis of HJ anastomoses, where an endoscopic approach is usually not possible or when endoscopy fails [6, 11]. Although the use of internal–external biliary drainage catheters used with this technique demands more intensive care and regular tube changes, it provides the advantage of an access route for reinterventions, if needed. Results of more recent studies evaluating patency rates after PTBD and balloon dilation of benign biliary strictures vary widely and range from 70 to 100 % at 1 year, decreasing to 41 % at 25 years after treatment [12–19]. Most studies, however, consist of relatively small series

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with limited long-term patency data or describe patient populations of large heterogeneity, with a mixture of patients with postoperative and primary strictures. Also, data analyses often consist of one bulky calculation of all factors at once instead of increasing the accuracy by selecting only those factors that might be significant. To our knowledge, no specific factors have been shown to predict the outcome of the treatment. The purpose of this study was to determine the shortterm and long-term effectiveness of percutaneous balloon dilation and long-term drainage of postoperative benign biliary strictures, to assess the effects on liver function by means of blood serum analysis, complications of this technique, and to investigate whether there are specific factors that can predict the outcome of the treatment.

Materials and Methods Patients All patients in whom PTBD procedures had been performed for treatment of postoperative biliary strictures at our institution between January 1, 1999, and December 31, 2011 were identified retrospectively by searching the interventional radiology database. Due to the structure of the database, the search could not focus on postoperative benign strictures only, and patients with primary benign strictures, malignant strictures, absence of strictures at further investigation, patients who did not undergo dilation treatment, patients who underwent part of the treatment elsewhere, or patients who had treatments outside the set time period, were excluded later on. The decision whether to perform PTBD or surgery was made during a weekly multidisciplinary meeting of hepatopancreatobiliary surgeons, gastroenterologists, and interventional radiologists, based on the patient’s clinical presentation, surgical history, imaging findings, and comorbid conditions. Data regarding patient characteristics (gender, age, presenting symptoms, previous surgical interventions, occurrence of vascular damage during surgery, and the presence of bile stones), the biliary strictures (the number, location, and causes of the strictures, and the time interval between a previous intervention and the diagnosis of a biliary stricture), and the PTBD treatment (the number of treatments per patient, the technical success of treatments, the access route to the biliary system, complications, the number of dilation sessions, the maximum dilation diameter, the duration of drainage, and whether patients had recurrent strictures) were recovered from digital medical and imaging records. Also, if measured both before and after treatment, total serum bilirubin, ASAT, ALAT, ALP, and c-GT were reviewed. Follow-up was conducted by reviewing medical records during February 2012.

J. J. Janssen et al.: Percutaneous Treatment of Benign Biliary Strictures

A

B

C

D

Fig. 1 PTBD in a 48-year-old female with a postoperative benign biliary stricture. A Cholangiography from the left side indirectly showing the stricture (white arrow), because there is no drainage of contrast to the duodenum (white arrow). B After passing the stricture

with a guidewire, the dilation balloon (between black arrows) has been inflated; the indentation (white arrow) is caused by the stricture. C Disappearance of the indentation, suggesting the stricture is resolved. D An internal–external biliary drainage catheter was placed

Technique

of the intrahepatic biliary system with a 22G Chiba needle, an introducer set (Neff-setÒ, Cook Medical Europe Ltd, Limerick, Ireland) was used to place an 8 F vascular access sheath for diagnostic cholangiography and intra-procedural drainage. The stricture was passed using a hydrophiliccoated 0.035-inch guidewire (Terumo Europe NV, Leuven, Belgium) and dilated to 4–10 mm with a conventional angioplasty balloon (OPTAÒ Pro PTA dilatation catheter, Cordis Corporation, Bridgewater, NJ, USA), over a stiff guidewire. Stones, when present in combination with the stricture, were removed with saline flushing and Dormiabaskets, pushing the stones into the jejunum, if necessary after crushing them with the Dormia-basket. The balloon size was estimated based on the cholangiogram. If necessary, a bigger balloon was used for a second dilation. Inflation time and pressures were not monitored; inflation pressure depended on pressure needed to fully expand the balloon. If passing the stricture failed, a 10 F external

All PTBD procedures were performed by interventional radiologists with more than 10 years of experience in biliary intervention. Immediately before every procedure, prophylactic broad-spectrum antibiotics were administered intravenously. A combination of 2.5–5 mg of midazolam and 50–100 lg of fentanyl, administered intravenously, was used for moderate sedation. For local anaesthesia, 10–20 mL of lidocaine 2 % was administered subcutaneously. During and after the procedure, the patient’s vital signs were monitored and O2 was administered if needed. The intrahepatic biliary system was approached from the left side only (subxiphoid approach, shown in Fig. 1) in 61 treatments, from the right side only (sub- or intercostal approach) in 54 treatments, bilateral in 18 treatments, and retrograde (via a percutaneous approach of the jejunum) in three treatments. Following the ultrasound-guided puncture

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J. J. Janssen et al.: Percutaneous Treatment of Benign Biliary Strictures

biliary drainage catheter was placed and the patient returned within a week for another attempt. An internal– external biliary drainage catheter (8.5–12 F) was placed after all balloon dilation procedures. Patients were scheduled for elective tube changes, if necessary combined with balloon dilation of the stenosis, at 3-week intervals for of up to a minimum of 3 months. If a control cholangiogram after 3 months showed satisfactory results, the internal–external biliary drainage catheter was replaced by a pigtail catheter, placed in the bile ducts above the former level of obstruction. The pigtail catheter was left in for at least a week to see if the patient would do clinically well after removing the stent across the treated stricture. If the patient developed cholangitis or signs of cholestasis easy access to the biliary system was still present and could be used for additional treatment. Definition of Terms A treatment is the complete effort to treat a patient with a benign biliary stricture, from the first balloon dilation until removal of the last drainage catheter. A treatment was considered a clinical success when completed by successful removal of the last drain, instead of proceeding directly to a surgical intervention. A dilation session is the dilation of one or more strictures, performed in a single radiological intervention. One treatment can consist of multiple dilation sessions. Procedures were considered technically successful when a dilation balloon was inflated across the stricture with the disappearance of indentations in the balloon, if present. Follow-up was defined as the time from the end of the last treatment until the last known moment without clinically relevant restenosis, or death. Clinically relevant restenosis occurred when a treated patient visited a physician because of recurrence of symptoms caused by cholestasis or cholangitis. Data Analysis All statistical analyses were executed with IBM SPSS Statistics 20 (IBM Corporation, Armonk, NY, USA). Differences were considered to be significant if P \ 0.05. Kaplan–Meier curves of the probability of a patient not having clinically relevant restenosis were generated to assess patency in time. The measured blood markers were analyzed with a Wilcoxon signed-ranks test to assess whether they were significantly decreased after treatment. For a clinically more relevant outcome, a McNemar test was used to assess whether the blood markers decreased to a value within normal range in a significant number of patients. To assess the influence of different variables on the development of restenosis, variables were first analyzed

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with a univariate Cox-regression analysis. Because of multiple odds ratios, variables consisting of more than two categories were analyzed using a Chi-square test comparing -2 Log Likelihood tests. Variables with a P \ 0.1 were included in a multivariate Cox-regression analysis. The same principle applied for the univariate and multivariate logistic regression tests that were used to assess the influence of patient characteristics on the clinical success of treatments. Here also applied that a P value of 0.1 was the demarcation whether to include a factor in the multivariate analysis or not.

Results Ninety-eight patients were included (39 men, 59 women; aged 2–85 years; mean age, 53 years). Excluded patients are shown in Fig. 2. Presenting symptoms were fever, rigors, pain, jaundice, and pruritus and were seen in 53, 35, 49, 32, and 14 % of the patients, respectively. In 90 patients, a HJ was performed previously, laparoscopic cholecystectomy in 5 patients, open cholecystectomy in 3 patients, and inflammation in 4 patients. Iatrogenic damage of the biliary system occurred during a previous cholecystectomy was the reason for surgical intervention in 54.1 % of the patients. Nineteen patients had multiple strictures. Eighty-seven strictures were located at an HJ anastomosis. Of the nonanastomotic strictures, seven were classified as bismuth II, and four as Bismuth IIIb, according to the bismuth classification of biliary strictures. The interval between previous interventions, and the diagnosis of biliary strictures, varied from 0 to 370 months (median, 24.5 months). Thirty patients had concomitant bile duct stones. In these 98 included patients, a total of 333 dilation sessions were performed as part of 134 treatments (Table 1). Technical success was achieved in 132 of 134 treatments (98.5 %), as we were unable to pass the stricture with a guidewire in two patients, due to a complete occlusion of the bile ducts. Procedure-related complications were seen in 11 patients (11.1 %). Partial dislocation of the drainage catheter occurred in five patients and was the most common complication and was in all cases manageable by tube change. Three patients developed a liver abscess. Sepsis that lead to prolonged hospital stay occurred in two patients and haemobilia that required embolization occurred once. In 13 patients (13.3 %), the catheter was not removed, and the treatment was converted to surgical intervention because of treatment failure (13/134 treatments, 9.7 %). In 2 of 13 patients, there was a total occlusion of the bile ducts, which could not be passed via a percutaneous approach. Eight of 13 patients had persistent strictures and

J. J. Janssen et al.: Percutaneous Treatment of Benign Biliary Strictures Fig. 2 Diagram showing included and excluded patients

Patients who received PTBD with dilation 222

Excluded patients 124

Included patients 98

Malignant stenosis 105

Treatment started or completed elsewhere 4

Treatment not within set time range 9

Too much missing data 6

Table 1 Treatment characteristics Number of patients with 1 treatment

66/98 (67.3 %)

2 treatments

28/98 (28.6 %)

3 treatments

4/98 (4.1 %)

Total number of treatments

134

Technically successful treatments

132/134 (98.5 %)

Failed treatments

13/134 (9.7 %)

Complications

11/134 (8.2 %)

Drain migration

5/134 (3.7 %)

Abscess

3/134 (2.2 %)

Severe bleeding

1/134 (0.7 %)

Sepsis

2/134 (1.5 %)

Dilation sessions

Total 333; median 2 sessions/ treatment

Drainage length, weeks

2–69; median 14

Follow-up length, months

0–146; median 35

no decrease of symptoms after dilation. Of these eight patients, two were already scheduled for surgical management because of an incisional hernia and an intestinal herniation through the mesocolon near the Roux-en-Y anastomosis. Two of 13 patients had intrahepatic bile duct stones that were considered too extensive for percutaneous removal. In 1 of 13 patients, there was dehiscence of a laparotomy wound, leading to formation of a biliary fistula. Follow-up ranged from 0 to 146 months, with a median of 35 months. Of 85 patients who entered follow-up, 10 developed clinically relevant restenosis after 2–89 months of follow-up (median 22 months). The Kaplan–Meier

curves determined the probability of a patient not having clinically relevant restenosis at 1, 2, 5, and 10 years after their last treatment as 0.82, 0.8, 0.76, and 0.62, respectively, in all patients, and as 0.95, 0.92, 0.88, and 0.72, respectively, if corrected for the 13 patients in whom the treatment was discontinued (Fig. 3). Of the ten patients with clinically relevant restenosis, four patients underwent surgical intervention. One of these patients was operated because of a total occlusion of a bile duct, two patients had recurrent cholangitis despite multiple dilations, and one patient had intrahepatic bile stones considered unsuitable for percutaneous removal as well as a choledochal cyst, which had not been diagnosed earlier on. Combined with the 13 patients who were operated on because of treatment failure, a total of 17 of 98 patients were treated surgically. Seven patients (7.1 %) died during the follow-up period due to causes unrelated to biliary tract disease. All were considered to have had a successful outcome of the percutaneous treatment. Seventy-five patients remained free of symptoms until the end of follow-up and therefore were considered successfully treated with PTBD and balloon dilation. Measurements of total serum bilirubin, ASAT, ALAT, ALP, and c-GT, both before and after treatment, were available in 49 patients. After treatment, all of these markers were significantly decreased. Also, all blood markers decreased to a value within normal range in a significant number of patients, as shown in Table 2. Using a univariate Cox-regression analysis, the gender of the patients and number of received treatments were included in the multivariate Cox-regression analysis. A

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J. J. Janssen et al.: Percutaneous Treatment of Benign Biliary Strictures Fig. 3 Kaplan–Meier plot showing the probability of a patient not having clinically relevant restenosis over time

Table 2 McNemar test; whether blood markers decreased to normal values in a significant number of patients n = 49

Before treatment

After treatment

P

Raised

Normal

Raised

Normal

Bilirubin, lmol/L

29

20

13

36

0*

ASAT, U/L 37 °C

41

8

23

26

0*

ALAT, U/L 37 °C ALP, U/L 37 °C

39 46

10 3

22 34

27 15

0* 0*

c-GT, U/L 37 °C

46

3

37

12

0.004*

* Decreased to normal in a significant number of patients, P \ 0.05

significant effect on clinically relevant restenosis was found for the number of received treatments, but not for the gender of the patients (Table 3). The number of strictures, duration of the last drainage period, and the number of received treatments were included in a multivariate logistic regression analysis. Significant effects on the development of clinically relevant restenosis were found for the number of strictures, and the number of received treatments (Table 4).

Discussion The current series analyzes both short and long-term patency after percutaneous treatment of postoperative benign biliary strictures. To our knowledge, this study is the first to assess the effects of PTBD and balloon dilation of postoperative strictures on liver function by means of normalization of blood serum markers. Benign biliary strictures are frequently seen after biliary operations. Management can be challenging, and restenosis with recurrent symptoms is commonly seen. Until recently, surgical HJ has been considered as the treatment of choice,

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with a clinical success rate of 80–90 %, a complication rate of 20–33 %, mortality up to 2.2 %, and a restenosis rate of 10–30 % [1–4, 20–24]. The combination of PTBD and balloon dilation offers a less invasive therapy. Several studies have shown technical success rates of 93–100 %, complication rates of 5–20 %, and a probability of a patient not having clinically relevant restenosis at 1 year after the treatment of 0.7–1.0, decreasing to 0.56–0.81 at 2 years after the treatment, and 0.52–0.7 at 5 years after the treatment [12–19]. Even though most benign biliary strictures are iatrogenic, to date, only Bonnel and Fingerhut [14] have reported of a large population consisting solely of postoperative patients, using correct statistical analyses. In our series of postoperative patients, the found technical success rate of 98.5 %, complication rate of 11.1 %, and probability of patency at 1, 2, 5, and 10 years after treatment of 0.95, 0.92, 0.88, and 0.72, respectively, correspond to the results of Bonnel and Fingerhut [14]. As in many studies, results at 10 years after treatment are based on only a few patients and therefore might not be very accurate. However, in these series, the results at 5 years of follow-up are based on 21 patients and therefore are significant, especially because previous studies have shown that 80 % of restenoses occurs within the first 5 years [25, 26]. Total serum bilirubin, ASAT, ALAT, ALP, and c-GT all decreased significantly after treatment. Moreover, all decreased to a value within normal range in a significant number of patients, indicating functional restoration of patency of the bile ducts. A study by Kaya et al. [27] found similar results in patients with biliary strictures due to primary sclerosing cholangitis, analyzing the course of total serum bilirubin, ALP, and ASAT, after both percutaneous and endoscopic treatment. Despite the fact that we have studied as many different potentially relevant variables as possible, the data from our

J. J. Janssen et al.: Percutaneous Treatment of Benign Biliary Strictures Table 3 Univariate and multivariate Cox-regression analysis; effects of several factors on the development of clinically relevant restenosis Univariate analysis P

Multivariate analysis

EXP(b)

95 % CI of EXP(b)

P

EXP(b)

95 % CI of EXP(b)

0.074

0.405

0.15–1.092

0.038¤

1.885

1.036–3.432

Gender

0.093*

0.428

0.159–1.152

Age

0.714

0.995

0.971–1.021

Cause of stricture

0.642 

NAa

Vascular damage

0.597

1.391

Indication for previous intervention

0.584 

NAb

Interval surgery—stricture

0.434

0.997

0.99–1.004

Location of stricture Number of strictures

0.148 0.242

1.681 1.709

0.831–3.4 0.697–4.194

Bile stones

0.565

1.281

0.551–2.98

Maximum dilatation diameter

0.704

1.064

0.771–1.469

Duration of last drainage

0.213

1.021

0.988–1.055

Number of treatments

0.054*

1.839

0.991–3.411

 

0.41–4.726

c

Approach

0.452

NA

Complications yes /no

0.795

0.825

0.193–3.523

NA not applicable * Significant P value \ 0.1 included in multivariate analysis; ¤ significant P value \ 0.05;   multiple categories, multiple odds ratios; P = Chisquare test comparing -2 Log Likelihood tests a

Reference category = hepaticojejunostomy

b

Reference category = no previous intervention

c

Reference category = bilateral approach

Table 4 Univariate and multivariate logistic regression analysis; effects of several factors on treatment failure Univariate analysis

Multivariate analysis

P

EXP(b)

95 % CI of EXP(b)

Gender

0.478

1.575

0.449–5.522

Age

0.935

1.001

0.967–1.037

 

P

EXP(b)

95 % CI of EXP(b)

0.043¤

0.249

0.065–0.956

a

Cause of stricture

0.598

Vascular damage

0.612

0.651

Indication for previous intervention

0.423 

NAb

Interval surgery — stricture

0.817

0.999

0.992–1.006

Location of stricture Number of strictures

0.995 0.072*

0.996 0.315

0.28–3.535 0.09–1.108

Bile stones

0.989

0.992

0.28–3.513

Maximum dilatation diameter

0.753

0.93

0.59–1.464

Duration of last drainage

0.066*

0.955

0.909–1.003

0.159

0.963

0.913–1.015

Number of treatments

0.033*

0.366

0.145–0.922

0.046¤

0.373

0.13–0.959

Approach

0.439 

NAc

Complications yes/no

0.612

0.651

NA

0.124–3.417

0.124–3.417

NA not applicable * Significant P value \0.1, included in multivariate analysis; square test comparing -2 Log Likelihood tests a

¤

significant P value \0.05;

 

multiple categories, multiple odds ratios; P = Chi-

Reference category = hepaticojejunostomy

b

Reference category = no previous intervention

c

Reference category = bilateral approach

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J. J. Janssen et al.: Percutaneous Treatment of Benign Biliary Strictures

study do not help to predict which patients will not respond to treatment, or which patients will have a high chance for developing early recurrence of bile duct stenosis. For those patients, alternative treatments may be indicated when balloon dilation and long-term drainage fail. Recent studies suggest that the use of percutaneously placed retrievable covered stents may yield good results in the treatment of benign biliary strictures [28, 29]. However, this technique has not specifically been evaluated in patients with postsurgical and anastomotic strictures and also is associated with the use of long-term indwelling biliary catheters. Long-term outcomes of this technique, as well as comparison with the use of balloon dilation and long-term catheter drainage, are currently unavailable but should be the subject of further studies. Another innovative treatment, which may show benefits for patients who are refractory to treatment with balloon dilatation and long-term drainage, is placement of biodegradable biliary stents. Preliminary experience with this technique shows promise but is very limited, and long-term data are currently lacking [30]. The costs of the interventional radiological treatment of benign biliary strictures, under conscious sedation and outpatient basis, could not be derived from the medical records of the included patients. Nevertheless, it is likely that these are lower than the costs of surgical treatment, requiring total anesthesia and hospitalization for a mean of 24 days [22]. Limitations of this study include its retrospective nature and, as stated before, the limited size of the (sub)groups. It was not possible to solve this problem by including more patients, due to the lack of a consistent treatment protocol before 1999. For a similar reason, a comparison with endoscopic treatment was not possible, as the majority of the included patients had postoperative strictures unsuitable for endoscopic treatment. Furthermore, minor complications and pain were not recorded systematically in patients’ medical records. Because PTBD and balloon dilation are not infrequently experienced as painful, it might be useful to assess this in the future. Also, patient preferences and the effects of an internal–external biliary drainage catheter on a patient’s daily activities have yet to be assessed. In conclusion, PTBD with balloon dilation and temporary stenting should be considered as treatment of choice in patients with postoperative benign biliary strictures. In experienced hands, it demonstrates reproducible good long-term effectiveness with a low complication rate. The effectiveness not only manifests itself as patent bile ducts in a symptom-free patient, but also in normalization of blood serum markers of liver function. Treatment failure occurred more often in patients with multiple strictures or treatments, whereas clinically relevant restenosis occurred more often in patients who needed multiple treatments.

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Conflict of interest The authors, Jan Jaap Janssen, Otto M. van Delden, Krijn P. van Lienden, Erik A.J. Rauws, Olivier R.C. Busch, Thomas M. van Gulik, Dirk J. Gouma, and Johan S. Lame´ris, all declare that they have no conflict of interest.

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Percutaneous balloon dilatation and long-term drainage as treatment of anastomotic and nonanastomotic benign biliary strictures.

This study was designed to determine the effectiveness of percutaneous balloon dilation and long-term drainage of postoperative benign biliary strictu...
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