Percutaneous Management of Resistant Biliary-Enteric Anastomotic Strictures with the Use of a Combined Cutting and Conventional Balloon Cholangioplasty Protocol: A Single-Center Experience Amar Mukund, MD, S. Rajesh, MD, PDCC, Nitesh Agrawal, MD, PDCC, Asit Arora, MCh, and Ankur Arora, MD, DNB, FRCR
ABSTRACT Purpose: To evaluate the safety and technical efﬁcacy of percutaneous transhepatic dilation of resistant biliary-enteric anastomotic strictures using a combination of cutting and conventional balloons and evaluate midterm results. Materials and Methods: A retrospective review of patients with biliary-enteric anastomotic strictures treated with percutaneous transhepatic cutting balloon dilation was performed. Cutting balloon dilation was followed by dilation with the use of a conventional balloon with a diameter larger than that of the cutting balloon. Technical success was deﬁned by the composite criteria of ﬂuent passage of manually injected contrast medium through the anastomoses into the small bowel and absence of bile duct dilatation compared with the cholangiogram obtained before the procedure. Clinical and laboratory parameters, including serum bilirubin, alkaline phosphatase, and total leukocyte counts, were monitored in all patients at regular intervals after a technically successful procedure. Results: Between January 2012 and September 2013, eight patients (three men and ﬁve women) with a mean age of 50 years (range, 32–75 y) underwent 11 sessions of combined cutting and conventional balloon cholangioplasty. The procedure was technically successful in all patients. There were no major complications during the procedure. During the follow-up period (mean, 14 mo; range, 8–24 mo), all patients remained free of any biliary obstructive symptoms and had normal laboratory parameters with the absence of biliary dilatation on ultrasound examinations. Conclusions: Cutting balloon dilation is a safe adjunctive option for the treatment of biliary-enteric anastomotic strictures resistant to conventional balloon dilation with acceptable midterm patency rates.
Despite reﬁnements in surgical techniques, biliary-enteric anastomotic strictures after surgical repair of iatrogenic bile duct injuries and liver transplantation continue to be a signiﬁcant cause of morbidity and mortality in this group of patients (1–3). With advances in interventional radiologic and endoscopic procedures, the primary management of these patients over the years has shifted from a predominantly surgical approach to these less invasive From the Departments of Interventional Radiology (A.M., S.R., N.A.), Hepatobiliary Surgery (As.A.), and Radiology (An.A.), Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, Off Abdul Gaffar Khan Marg, New Delhi 110070, India. Received September 9, 2014; ﬁnal revision received November 20, 2014; accepted December 9, 2014. Address correspondence to S.R.; E-mail: [email protected]
methods (2,3). Because an endoscopic approach is technically difﬁcult in patients with biliary-enteric anastomoses, percutaneous serial balloon dilation and catheter maintenance has become common at most centers (1,3– 5). However, owing to the ﬁbrous nature of these strictures, results of percutaneous management are highly variable (6–8). Preliminary evidence suggests that peripheral cutting balloons may be effective in biliary strictures not responsive to standard measures (9–13). The purpose of this study was to determine the safety and technical efﬁcacy of transhepatic dilation of resistant biliary-enteric anastomotic strictures using a combination of cutting and conventional balloons and evaluate its mid-term results.
None of the authors have identiﬁed a conﬂict of interest. & SIR, 2015 J Vasc Interv Radiol 2015; 26:560–565 http://dx.doi.org/10.1016/j.jvir.2014.12.011
MATERIALS AND METHODS Departmental review board approval was obtained for this study. A retrospective search of the hospital database
was conducted for patients who had undergone cutting balloon dilation for benign biliary-enteric strictures at our institute between January 2012 and September 2013 after failed conventional balloon dilation. The search revealed eight patients (three men and ﬁve women) with
a mean age of 50 years (range, 32–75 y), who formed the study population. One patient had undergone live donor liver transplantation, and the others had undergone surgical repair of bile duct injuries sustained during laparoscopic cholecystectomies. All patients presented
Table 1 . Demographic Proﬁle, Disease Characteristics, and Follow-up Details of the Study Population No. Sessions Technical Patient No.
Time Delay between Surgery
Maximum Diameter of
and Index Presentation (mo)
Conventional Balloon Used (mm)
F ¼ female; M ¼ male. *After liver transplant hepaticojejunostomy stricture. Other patients had biliary-enteric anastomosis after surgical repair of iatrogenic bile duct injuries.
Figure 1. (a) Transhepatic cholangiogram showing signiﬁcant narrowing at the hepaticojejunostomy anastomotic site (arrow) with upstream dilatation of intrahepatic biliary radicals. (b) Cutting balloon (arrowheads) being employed for dilation of the stricture site followed by (c) dilation with conventional balloon (arrowheads). (d) Follow-up cholangiogram showing signiﬁcant resolution of the anastomotic stricture (arrow).
Cutting Balloon Cholangioplasty
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3 months to 2 years (mean, 9.5 mo) after the surgery with features of worsening obstructive jaundice and cholangitis. Patient demographics and baseline clinical proﬁles are provided in Table 1.
12-F internal-external biliary drainage catheter (Cook, Inc, Bloomington, Indiana) was left in place for future access. After three unsuccessful attempts, the patients were offered the option of surgical revision or cutting balloon dilation.
Protocol All patients underwent percutaneous transhepatic biliary drainage at presentation followed by dilation with highpressure conventional angioplasty balloons of maximum diameter 10–14 mm (Ultra-Thin Diamond and XXL; Boston Scientiﬁc, Marlborough, Massachusetts) in the same or subsequent sitting (within 4–7 d). These balloons were inﬂated up to 12 atm for a period of 3 minutes up to a maximum of three times, each time followed by cholangiography to assess the response. This protocol was repeated at intervals of 3–4 weeks during which a 10-F to
Figure 2. Flowchart of the treatment protocol followed at our institute in the management of postoperative biliary-enteric anastomotic strictures.
Cutting Balloon Dilation Session All procedures were done on outpatient basis with the patient under conscious sedation using a combination of fentanyl citrate and midazolam. Prophylactic intravenous antibiotics (1 g ceftriaxone or 4.5 g piperacillin/tazobactam) were administered within 1 hour before the procedure in all patients. The preexisting percutaneous transhepatic biliary drainage catheter was exchanged for a 7-F vascular access sheath over a 0.038-inch hydrophilic-coated guide wire (Terumo Corp, Tokyo, Japan), and a baseline cholangiogram was obtained. Subsequently, using a 5-F multipurpose or Kumpe catheter (AngioDynamics, Queensbury, New York), the 0.038-inch guide wire was exchanged for an 0.018-inch guide wire (Boston Scientiﬁc). A peripheral cutting balloon (Boston Scientiﬁc) was introduced over the 0.018inch guide wire through the sheath and across the strictured segment. We uniformly used an 8-mm diameter cutting balloon with a shaft length of 135 cm in all patients. Each session involved inﬂating the balloon up to 10 atm for 3 minutes, followed by a side-arm sheath cholangiogram to assess the response (Fig 1a–d). In the case of an unsatisfactory result, deﬁned by retention of manually injected contrast medium in the intrahepatic ducts and persistence of biliary dilatation compared with the cholangiogram obtained before dilation, the maneuver was repeated for a maximum of three times. Subsequently, conventional balloon dilations were performed with 10–14 mm diameter balloons inﬂated up to 12 atm. After the dilation session, a 10-F to 12-F internal-external biliary drainage catheter (Cook, Inc, Bloomington, Indiana) with its external end capped was left in place, and the patient was scheduled for a cholangiogram 3 weeks later. If the procedure was technically successful, the patient was asymptomatic during the interval period with normal laboratory parameters compared with values before the procedure, and no anastomotic restenosis was noted on the cholangiogram, the biliary drainage catheter was removed. In the event of failure or recurrence of stricture, the procedure was repeated. The management protocol followed at our institute is summarized in Figure 2.
Table 2 . Laboratory Test Results before and after Treatment Laboratory Parameters Total serum bilirubin, mg/dL (normal, 0.3–1.2) Serum alkaline phosphatase, IU/L (normal, 32–92) Total leukocyte count, 103/mL (normal, 4–11) Values are mean ± SD.
Follow-up (3 mo)
1.1 ⫾ 0.9
0.9 ⫾ 0.4
0.6 ⫾ 0.7
Follow-up (6 mo) 0.7 ⫾ 0.4
134.5 ⫾ 177.4
116.8 ⫾ 102.6
101.7 ⫾ 84.2
90.2 ⫾ 68.1
8.2 ⫾ 3.4
7.1 ⫾ 2.4
6.1 ⫾ 3.3
6.2 ⫾ 3.9
Kakani et al, 2006 (13)
No. patients Mean age, y (range)
5‡ 55 (33–70)
22 50 (21–70)
8 50 (32–75)
Post–liver transplant (n ¼ 3)
injuries (n ¼ 7) Mean treatment sessions/patient Diameter of cutting balloon (mm)/maximum
Failed sphincterotomy (n ¼ 1) NA§ 7–8/10
pressure (atm) Duration of cutting balloon inﬂation (min)
Duration of conventional balloon inﬂation (min) Interval between dilation sessions
NR 4–7 d
5–10 1–3 wk
1 6 þ 2 wk¶
3 19–35 d
Diameter of biliary catheter used in
Maximum diameter (mm) of conventional balloon used (mean)/maximum
liver transplant (n ¼ 1) Iatrogenic biliary
Iatrogenic biliary injury (n ¼ 1)
Lee et al, 2012 (12)
Saad et al, 2006 (10)
Atar et al, 2005 (9)*, 2007 (11)†
Table 3 . Summary of Previous Reports in the English Medical Literature on the Use of Cutting Balloons in the Management of Resistant Anastomotic Biliary Strictures and Comparison with the Present Study
interval period (F) Technical success (%)
Major complications Mean follow-up
None 24 mo
None 10 mo
None 13 y
None 14 mo
Primary patency rate (%) Restenosis rate (%)
50 (2/4) 50 (2/4)
Duration of treatment, wk (mean)
Secondary patency rate (%)
NA ¼ not applicable; NR ¼ not reported. *Early and midterm results. † Long-term results. ‡ Number of patients with biliary strictures treated with cutting balloon. § Only single session was performed for each patient. ‖ Single session of cutting balloon dilation was performed, which was not followed by use of a conventional balloon. ¶ After demonstrating patency of the anastomosis at 6 wk after dilation, a 10-F external biliary drain was left in place for an additional 2 wk. # Cutting balloon dilation was done immediately or within 4–7 d after failed conventional high-pressure balloon dilation. 563
Cutting Balloon Cholangioplasty
Study Endpoints and Follow-up Technical success was deﬁned by the composite criteria of “ﬂuent passage” of manually injected contrast medium through the anastomoses into the small bowel and absence of bile duct dilatation compared with the cholangiogram obtained before the procedure. Patients were followed up clinically and by laboratory parameters including serum bilirubin, alkaline phosphatase, and total leukocyte counts at 3, 6, and 12 months after the procedure and every 6 months thereafter. During all follow-up visits, ultrasonography was also performed to assess the status of the biliary tree. Clinical success was deﬁned by the absence of biliary obstructive symptoms (obstructive jaundice and cholangitis) coupled with normal laboratory parameters (compared with values before the procedure) and the absence of biliary dilatation on ultrasonography. Complications were recorded and deﬁned according to the Society of Interventional Radiology (SIR) classiﬁcation (14).
RESULTS The study group underwent an average of 4 sessions (range, 3–8; total 34 sessions) of dilations with conventional balloons before cutting balloon dilatation. The average time period spent with an indwelling biliary drainage catheter was 14 weeks (range, 9–32 wk). An 8-mm cutting balloon was used in all patients. The diameter of conventional balloons used for subsequent dilation ranged from 10–14 mm (mean, 12 mm). The procedure was technically successful in all patients. The mean duration of treatment was 6.6 weeks (range, 3–9 wk). The mean interval between dilation sessions was 22 days (range, 19–35 d).
Follow-up During the follow-up period (mean, 14 mo; range, 8–24 mo), all patients in the study group remained free of any biliary obstructive symptoms with no further episodes of cholangitis. The laboratory parameters remained within normal limits compared with values before the procedure (Table 2). In addition, no evidence of biliary dilatation was noted on the follow-up ultrasound examination. There were no major procedure-related complications. Minor complications including signiﬁcant parietal pain (n ¼ 2), episodes of chills (n ¼ 2), and hemobilia (n ¼ 1) were managed on an outpatient basis.
DISCUSSION Initial experience with the use of a peripheral cutting balloon in the management of benign postoperative anastomotic biliary strictures has shown promising results (9–13). The present study adds to the experience in the use of these balloons for management of postoperative anastomotic biliary strictures which has been limited so far to a few retrospective reviews and a case
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report (6–10). We achieved a 100% technical success rate with our combined cutting and conventional balloon dilation protocol; therapy with conventional balloons alone has a failure rate of up to 33% (6–8). Our results also compare favorably with the outcome of the two other clinical studies on this subject (Table 3). No major complications were seen, and no instance of recurrence was evident in any of the patients after a mean follow-up of 14 months. Because of a lack of evidence-based research, there are numerous variations among institutions in the way balloon dilation for treatment of benign biliary strictures is performed. It follows that several technical aspects of this procedure, including balloon sizing, interval between dilation sessions, drainage catheter size, and response evaluation, have not been well established. These variations in dilation protocol are arbitrary and primarily depend on operator preference and institutional protocols. Generally, multiple sessions of dilation are performed with a maximum of three to six sessions depending on the institution (15). The time interval between each dilation session also varies ranging from 1 day to 3 weeks (15). Based on anecdotal evidence, we keep an interval of 3 weeks between two sessions of dilations to allow for stricture remodeling, and three sessions of dilations are performed before calling the procedure a technical failure. Several approaches to evaluation of response to balloon dilation have been described. The subjective method is visualization of “free ﬂow” of manually injected contrast medium through the anastomosis into the small bowel without being retained in the intrahepatic ducts. Alternatively, a clinical trial can be conducted by capping a drainage catheter placed in the bile duct above the stricture or into the bowel (8). If the patient tolerates tube capping with normal test results during the follow-up period, the catheter can be removed. More recently, stress manometry has been used to evaluate the response to stricture dilation objectively and predict long-term results (16). We did not use biliary manometry in our group of patients. A subjective evaluation of the cholangiographic appearance coupled with clinical follow-up was used in all patients. Shortcomings of this study were its retrospective nature, small study group, and a limited follow-up. However, our early experience suggests that cutting balloon dilation is safe and effective in the management of recalcitrant postoperative benign biliary-enteric anastomotic strictures.
REFERENCES 1. Laštovičková J, Peregrin J. Biliary strictures after orthotopic liver transplantation: long-term results of percutaneous treatment in patients with nonfeasible endoscopic therapy. Transplant Proc 2012; 44:1379–1384. 2. Ryu CH, Lee SK. Biliary strictures after liver transplantation. Gut Liver 2011; 5:133–142.
3. Choo SW, Shin SW, Do YS, et al. The balloon dilatation and large proﬁle catheter maintenance method for the management of the bile duct stricture following liver transplantation. Korean J Radiol 2006; 7:41–49. 4. Glas L, Courbière M, Ficarelli S, Milot L, Mennesson N, Pilleul F. Longterm outcome of percutaneous transhepatic therapy for benign biliary enteric anastomotic strictures. J Vasc Interv Radiol 2008; 19:1336–1343. 5. Kucukay F, Okten RS, Yurdakul M, et al. Long term results of percutaneous biliary balloon dilation treatment for benign hepaticojejunostomy strictures: are repeated balloon dilations necessary? J Vasc Interv Radiol 2012; 23:1347–1355. 6. Schumacher B, Othman T, Jansen M, Preiss C, Neuhaus H. Long-term follow-up of percutaneous transhepatic therapy (PTT) in patients with deﬁnite benign anastomotic strictures after hepaticojejunostomy. Endoscopy 2001; 33:409–415. 7. Vos PM, van Beek EJ, Smits NJ, Rauws EA, Gouma DJ, Reeders JW. Percutaneous balloon dilatation for benign hepaticojejunostomy strictures. Abdom Imaging 2000; 25:134–138. 8. Kocher M, Cerná M, Havlík R, Král V, Gryga A, Duda M. Percutaneous treatment of benign bile duct strictures. Eur J Radiol 2007; 62:170–174. 9. Atar E, Bachar GN, Bartal G, et al. Use of peripheral cutting balloon in the management of resistant benign ureteral and biliary strictures. J Vasc Interv Radiol 2005; 16(2 Pt 1):241–245.
10. Saad WE, Davies MG, Saad NE, et al. Transhepatic dilation of anastomotic biliary strictures in liver transplant recipients with use of a combined cutting and conventional balloon protocol: technical safety and efﬁcacy. J Vasc Interv Radiol 2006; 17:837–843. 11. Atar E, Bachar GN, Eitan M, Graif F, Neyman H, Belenky A. Peripheral cutting balloon in the management of resistant benign ureteral and biliary strictures: long-term results. Diagn Interv Radiol 2007; 13:39–41. 12. Lee AY, Gregorius J, Kerlan RK Jr, Gordon RL, Fidelman N. Percutaneous transhepatic balloon dilation of biliary-enteric anastomotic strictures after surgical repair of iatrogenic bile duct injuries. PLoS One 2012; 7:e46478. 13. Kakani NK, Puckett M, Cooper M, Watkinson A. Percutaneous transhepatic use of a cutting balloon in the treatment of a benign common bile duct stricture. Cardiovasc Intervent Radiol 2006; 29:462–464. 14. Burke DR, Lewis CA, Cardella JF, et al. Quality improvement guidelines for percutaneous transhepatic cholangiography and biliary drainage. J Vasc Interv Radiol 2003; 14(Suppl):S243–S246. 15. Saad WE. Percutaneous management of postoperative anastomotic biliary strictures. Tech Vasc Interv Radiol 2008; 11:143–153. 16. Haskal ZJ, Brown R Jr. Role of biliary stress manometry after biliary stricture dilation in living donor liver transplant recipients. J Vasc Interv Radiol 2008; 19:216–219.