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A review of percutaneous transhepatic biliary drainage at a tertiary referral centre
Clinical Radiology xxx (2016) e1ee5
Contents lists available at ScienceDirect
Clinical Radiology journal homepage: www.clinicalradiologyonline.net
A review of percutaneous transhepatic biliary drainage at a tertiary referral centre H. Asadi a, b, R. Hollingsworth a, K. Pennycooke a, P. Thanaratnam a, M. Given a, A. Keeling a, M. Lee a, * a
Interventional Radiology Service, Department of Radiology, Beaumont Hospital, Beaumont Rd, Beaumont, Dublin 9, Ireland b School of Medicine, Faculty of Health, Deakin University, Pigdons Road, Waurn Ponds, VIC 3216, Australia
art icl e i nformat ion Article history: Received 22 March 2016 Received in revised form 9 May 2016 Accepted 20 May 2016
AIM: To review percutaneous biliary drainage (PBD) procedures performed in Beaumont Hospital, Dublin, Ireland, over a 6-year period, to determine the 30-day morbidity and mortality. MATERIALS AND METHODS: A total of 119 patients undergoing 193 PBD procedures were identified over a 6 year period. Of the patients, 6.7% (eight patients) had stone disease, 63% (75 patients) had a malignancy, and the remainder were diagnosed with other conditions. Standard techniques of PBD and biliary stent insertion were applied, with 73 patients (61%) having same-day procedures and all undergoing gelfoam embolisation of percutaneous tracts. All patients received intravenous prophylactic antibiotics and intravenous hydration prior to PBD. RESULTS: The technical success rate was 97%, with a mean drop of 105 mmol/l between preand post-procedure bilirubin. Thirty-day mortality was 10.9% (13 deaths), with major and minor morbidities of 5% (six patients) and 7.6% (nine patients), respectively. Major complications included sepsis in two patients, major haemorrhage in two patients, and renal failure in two patients. Minor complications included infection in seven patients, bile leak causing selflimiting pain in one patient, and minor haemorrhage in one patient. CONCLUSION: The study confirms that PBD and stent insertion is a safe and effective technique in Beaumont Hospital, associated with an overall acceptable morbidity and mortality comparable with other studies. Ó 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Introduction Biliary obstruction may be due to benign, malignant, or iatrogenic diseases. The most common malignant cause of biliary obstruction is an underlying pancreatic neoplasm extrinsically compressing the distal bile duct. Other
* Guarantor and correspondent: M. Lee, Interventional Radiology Service, Department of Radiology, Beaumont Hospital, Beaumont Rd, Beaumont, Dublin 9, Ireland. Tel.: þ353 1 809 3000; fax: þ353 1 809 837 6982. E-mail address: [email protected] (M. Lee).
conditions include cholangiocarcinoma, as well as metastatic disease at the hepatic hilar nodes or in the peripancreatic nodes, causing obstructive jaundice from extrinsic pressure on the proximal or distal portions of the biliary tree.1e3 Benign diseases include inflammatory processes and stones as well as rare conditions, e.g., Mirizzi’s syndrome, along with benign tumours and iatrogenic or traumatic biliary injuries.4e7 A great majority of patients with biliary obstruction, in particular due to pancreatic neoplasms or stone disease, can be treated by endoscopic retrograde cholangiopancreatography (ERCP); however, those who fail ERCP, may require
http://dx.doi.org/10.1016/j.crad.2016.05.013 0009-9260/Ó 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013
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H. Asadi et al. / Clinical Radiology xxx (2016) e1ee5
percutaneous transhepatic biliary drainage (PTBD) to achieve adequate biliary decompression.1,2 PTBD is an effective method for the management of biliary abnormalities under imaging guidance using interventional radiology techniques, which involves sterile cannulation of a peripheral bile duct followed by guidewire and catheter positioning above the stricture.8,9 Subsequently, contrast material injection into an intra-hepatic bile duct will provide a cholangiogram, delineating the anatomy of the biliary tree, determining the location of obstruction, and helping to guide the intervention.2,9 Depending on the cholangiographic findings, placement of a catheter or stent may be considered to facilitate internal or external drainage of bile, allowing decompression of the biliary system.1,2,10 Apart from the primary underlying cause and the level of the biliary obstruction, different technical aspects of the interventional procedure, including the access, internal versus external biliary drainage, position and type of stent, tract embolisation and duration of drainage have all been investigated as factors that may influence the outcome of the percutaneous biliary drainage (PBD).11 PTBD is effective at relieving biliary obstruction; however, it has been associated with complications including sepsis, haemorrhage and localised infective, as well as inflammatory processes such as abscess, peritonitis, cholecystitis, and pancreatitis,2,12 with an overall 30-day in hospital mortality rate of approximately 20% in one recent study.13,14 The aim of the present study was to review PTBDs performed in a tertiary referral centre, Beaumont Hospital, Dublin, Ireland, and to assess technical success and 30 day morbidity and mortality rates.
Materials and methods As a retrospective audit, this study did not require approval from the institution’s ethics committee.
Concordant with the quality-improvement guidelines for PBD set out by the Society of Interventional Radiology (SIR) and the Cardiovascular Interventional Radiology Society of Europe (CIRSE),15 pre-procedural work-up also included liver function tests, coagulation profile, serum creatinine levels, and inflammatory markers. Abnormal laboratory parameters were optimised where necessary prior to the procedure. All patients were given pre-procedural prophylactic antibiotic coverage with 4.5 g of intravenous piperacillin/ tazobactam (Tazocin, Pfizer, Cork, Ireland) at least 1 hour prior to commencing the procedure. Patients were also adequately hydrated pre-procedure. The routine protocol required patients to receive 1 l of normal saline intravenously in the 12 hours before the procedure. All patients received conscious sedation and adequate analgesia with a combination of midazolam and fentanyl for the duration of the procedure in an incremental dose fashion depending on the patient’s clinical status. Using fluoroscopic guidance and the single puncture technique a 21 G fine-needle (Chiba, Cook, Bloomington, IN, USA) was used to gain access to a peripheral bile duct. A 0.01800 guidewire was used for initial access followed by a NeffSetÒ (Cook) and a 0.03500 J guidewire (Cook). A 0.03500 hydrophilic guidewire (Glidewire, Terumo, Shibuya-ku, Tokyo, Japan) was then used with the support of a 5 F KMP catheter (Cook) to cross the obstruction into the duodenum and a drainage catheter (Cook) or stent (Wallstent, BostonScientific, Marlborough, MA, USA, or Zimmon, Cook) was placed in the desired location depending on whether the patient was a surgical candidate or not. The percutaneous tract was then embolised with Gelfoam (Pfizer, New York City, NY, USA) torpedoes when the drainage catheter was removed, between the distal end of the percutaneous track and the biliary access point, either on the same day as initial PTBD or several days later if a single-stage procedure could not be performed.
Statistical analyses Data collection Retrospective review of a prospectively collected logbook from 2007e2013 discovered a total of 119 patients (67 male patients and 52 female patients) with an age range of 47 to 100 years (mean age of 70.6 years and SD of w11) who underwent 193 percutaneous biliary procedures. Technical success, complications, 30-day morbidity/mortality rates were extracted from the electronic medical records, review of chart and microfilm records, and anonymised. Subsequently the collated data were entered into an Excel (Microsoft, Redmond, WA, USA) spreadsheet.
Procedure and technique Pre-procedural work-up included cross-sectional imaging by magnetic resonance imaging (MRI), if hilar obstruction or computed tomography (CT), if low common bile duct obstruction to further characterise the underlying pathology in all patients.
SPSS (IBM, Armonk, NY, USA) and Rapidminer (RapidMiner, Cambridge, MA, USA) were used for data and statistical analyses.
Results On the pre-procedural imaging work-up it was shown that 43 patients (37%) suffered from cholelithiasis, choledocholithiasis, pancreatitis, and cholangitis or related complications, 75 patients (63%) had a malignant neoplastic condition, with 37/75 (49%) having a primary biliary, pancreatic, or hepatocellular malignancy; while the remainder were diagnosed with metastatic conditions (Electronic Supplementary Material, Table S1). Technical success was defined as the ability to complete all technical aspects of the procedure including crossing the lesion to provide internal drainage by stent or catheter. Three procedures (1.5%) failed technically as the obstructed
Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013
H. Asadi et al. / Clinical Radiology xxx (2016) e1ee5
lesions could not be crossed, but these patients were drained effectively by external drainage. Eighty-six (67 metal, nine plastic) stents were placed with eight patients receiving two metal stents. There were a total of 94 drains inserted, of which 75 were internaleexternal drains and the remainder were external drains only. Pre-procedural liver function tests demonstrated an average alkaline phosphatase of 724 IU/l (SD of 424 IU/l) and bilirubin of 200 mg/dl (SD of 147 mg/dl). The postprocedure average alkaline phosphatase (46l U/l SD of 298 IU/l) and serum bilirubin (158 mg/dl) decreased significantly by 37% (p<0.008) and 22.5% (p<0.01), respectively (Electronic Supplementary Material, Figs S1 and S2). The thirty-day post-procedure mortality was 10.9% (13 patients). In these latter cases, PTC was performed palliatively to improve quality of life in patients with symptoms of obstructive jaundice.16 The cause of death in all cases was determined to be underlying primary disease; 12 patients died due to complications of metastatic cancer and one due to complications of acute on chronic renal failure, which was not procedure related. Thirty-day morbidity was 12.6% (Table 1). Three patients in the study group had major haemorrhage. Ten patients in the present series were found having international normalised ratios (INRs) >1.5 at the time of procedure; however, the patient who eventually required multiple transfusions had in fact got an INR of 1.1 and bled from the primary inoperable ampullary adenocarcinoma on the background of severe pre- and post-procedural sepsis, which was unresponsive to antibiotic therapy. She eventually developed disseminated intravascular coagulopathy and passed away 7 days after the procedure. In Beaumont Hospital, the coagulation profile of the patients with an INR >1.5 is optimised with fresh frozen plasma prior to the procedure; however, for the sake of comparison with the BSIR audit with an unconventional INR reference of 1.3, it is worth mentioning that 31 patients in the present series had recorded INRs of 1.3 at the time of procedure with the remaining two patients, who suffered from major haemorrhage, requiring prolonged hospital stay, had INRs of just above 1.3. In addition, one patient in the series with a pre-procedure INR <1.3 suffered from a minor haemorrhage that did not require transfusion or prolonged hospital stay. One patient had a minor bile leak, which subsided with conservative management, and two of the present patients developed renal failure, which was defined as an increase in serum creatinine of >25% from baseline (Electronic
Table 1 Categorisation and incidence of the procedural morbidities. Complication
wPercentage
Sepsis
Minor 47% Major 13% 7% 13% Minor 7% Major 13%
Bile leak Renal failure Haemorrhage
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Supplementary Material, Appendix S1). Both of these patients had pre-existing sepsis prior to the procedure and the PTBD was performed after failed ERCP to drain the biliary system in an effort to improve sepsis. One patient developed acute-on-chronic failure, while the other developed acute renal failure, both of which were secondary to sepsis. Seven patients (6%) developed minor sepsis (Electronic Supplementary Material, Appendix S2). These patients had varying evidence of infection in the 10 days prior to the procedure, e.g., characterised by a mild temperature or minor increase in inflammatory markers, but did not meet the criteria for major sepsis. In the majority of cases, it is difficult to determine with any degree of certainty if sepsis was caused by the procedure itself or exacerbation of existing underlying infection present at the time of the procedure. Two patients developed major sepsis (Electronic Supplementary Material, Appendix S2). One patient required intensive care unit admission on two occasions postprocedure, eventually making a full recovery. Another became septic mid-procedure, causing the procedure to be aborted and rescheduled. As mentioned before, an additional two patients with renal failure also had major sepsis prior to the procedure, and therefore, were excluded from the analysis for procedural sepsis rate.
Discussion Most studies have shown that PTBD has a high technical success rate, with one recent study demonstrating a success rate >95%, but with a high 30-day mortality rate of 19.8% and significant morbidity of 34%.13 In comparison, in the present study, significantly lower mortality and morbidity rates of 10.9% and 12.6%, respectively, were demonstrated. The recent BSIR audit also reported that haemorrhage, sepsis, and renal failure were the most common major complications associated with the highest mortality risk, which is more or less consistent with the present findings from this series of patients.13 Complication rates vary amongst institutions and operators, which may be due to differences in patient status, operator experience, and technical challenges of the procedure. In general, complications may be classified into major and minor (Electronic Supplementary Material, Appendix S3), with the major complications classified as those that require hospital admission for an outpatient procedure, or those that cause an increase in the level of care or necessitate a prolonged stay for hospitalised patients, or lead to permanent unplanned sequelae or death.8,9,13,17 Conversely, minor complications may be classified as having no sequelae, necessitating minimal therapy, or short-stay hospital admission for observation.8,9,13,17 Major complications, such as haemorrhage, renal failure, and septicaemia, can be minimised with optimum patient management in the pre-procedural period. Interventions, such as appropriate pain management, prophylactic antibiotic administration, and fluid-replacement therapy, can help to reduce the complication rate.18
Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013
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Patient selection may also play a role in the wide range of factors important in complication rates and mortality, with a significant percentage of patients undergoing PTBD due to unresectable malignant disease. In the present study all patients who died in the 30-day post-procedural period, had an underlying diagnosis of malignancy, and obviously, in these instances the goal of PTBD is predominantly palliative to improve quality of life rather than being curative. It is worth noting that 12 of the 13 patients who died within 30 days of PBD had metastatic disease, and it may be worth evaluating life expectancy of these patients carefully before subjecting them to PBD. Patient compliance in the post-procedural period is also of paramount importance. Pain is the most common complication associated with PTBD and adequate analgesia should be administered to prevent the patient from tampering with biliary tubes. This can lead to biliary tube dislodgement and was the most documented chronic complication described in some studies.11 The latter can lead to an increased risk of biliary sepsis and peritonitis. Pre-procedural evaluation and preparation is important in identifying factors that may contribute to an increased complication rate. Patients undergoing PTBD procedures are often elderly, neutropenic, and have multiple comorbidities, and these secondary factors can contribute to a higher post-procedural complication rate. Overall, the incidence of complications has been reported to be higher in the patients suffering from malignant causes of obstruction. This is probably related to the rapid advancement of the primary disease and the potential coexisting treatment related immunosuppression; on the contrary, the mortality drastically decreases to approximately 16% accumulatively in a 3-year period post-procedural follow-up in those patients with benign conditions.12,19e21 In previous studies, antibiotic prophylaxis is an established prerequisite prior to the procedure and usually involves a combination of multiple agents or a broadspectrum antibiotic to achieve adequate coverage.8,13 Furthermore, in some studies the incidence of cholangitis in patients with underlying malignancy has been shown to be approximately 50% in total; in particular, it is twice as common in those with internal and external drainage than in those with external drainage alone.2,22 In addition, it has been shown that the longer the duration of PBD, the more likely the patient is to develop cholangitis.2,23 Infected bile has been detected in 25% to 36% of patients with malignant biliary obstruction,24 making pre-procedural administration of appropriate prophylactic antibiotics to this group of patients even more important; and overall, prophylactic antibiotic, including cover for Escherichia coli, Klebsiella, Enterococcus, Streptococcus, Enterobacter and Pseudomonas aeruginosa, is strongly recommended for all patients prior to biliary procedures, to minimise the risk of potential septic complications.2,10 Previously recommended prophylaxis regimens included ampicillin and gentamycin or cefotetan and mezocillin25; however, in Beaumont Hospital, the prophylactic antibiotic of choice is monotherapy with piperacillin/tazobactam (Tazocin, Pfizer, Cork, Ireland), which is a broad-spectrum
antibiotic that has Gram-negative, Gram-positive, and aerobic coverage, and importantly, high levels of biliary excretion. Given the fact that antibiotic prophylaxis is an important aspect of the pre-procedure protocol; it is felt to be a contributory factor in the low post-procedural sepsis rate with the major and minor infection rates being <2% and <6%, respectively. In comparison in the recent BSIR registry (Electronic Supplementary Material, Table S2), only approximately 50% of patients had received pre-procedural antibiotics, and no specific unified prophylactic regime was implemented. Given the above, the reported major and minor sepsis rates were 3.5% and 7.7%, respectively, in the BSIR registry.13 In addition, 59 patients in the BSIR registry had an INR reported to be >1.3, whereas only 29 patients in the present cohort had an INR >1.3.13 Optimisation of the patients’ coagulation status, combined with gelfoam embolisation of the access tract (Electronic Supplementary Material, Table S2),26 have both contributed significantly in reducing the present major peri-procedural haemorrhage rate to 1.5% compared to up to 3.5% reported in some large studies.26,27 Furthermore, the rate of biliary leak in the present study was negligible. In addition to the potential role in reducing the risk of haemorrhage, biliary tract embolisation from the access site to skin level has been correlated to a reduced incidence of bile leak, and a reduction in post-procedural pain experienced by patients26,27 Overall, since the quality improvement guidelines for PBD established by CIRSE15 have been implemented in Beaumont Hospital with almost 100% compliance, each PTBD patient was optimised in the pre-procedural period with prophylactic antibiotics, adjustment of the coagulation profile where necessary, IV hydration before the procedure, and access tract embolisation after the procedure. These factors most likely played a significant role in the relative improvement of patient outcomes with decreased 30-day morbidity and mortality. This study illustrates that, overall, PBD is an effective technique in improving liver function and reducing bilirubin levels and can be performed safely by experienced operators, with acceptable morbidity and mortality, and successful symptomatic relief. Implementing current recommended practice guidelines from CIRSE helps to decrease the potential morbidity and mortality associated with the procedure, and it is likely of benefit if these procedures are centralised in tertiary referral centres to increase subspecialty experience and enhance the ability to deal with possible complications.
Limitations The present study was conducted at a tertiary referral centre and a teaching hospital, with four experienced operators performing the procedures over a 6 year period; therefore, the results may not be generalised to other institutions with different level of expertise. In addition, a relatively high proportion of patients included in this study presented with benign causes of obstruction, which can potentially skew the final results. Other limitations of the
Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013
H. Asadi et al. / Clinical Radiology xxx (2016) e1ee5
study include its retrospective design, making a comprehensive assessment of all relevant clinical and biochemical factors almost impossible, as well as its relatively small number of cases, influencing the validity of the statistical comparison.
Appendix A. Supplementary data Supplementary data related to this article can be found at http://dx.doi.org/10.1016/j.crad.2016.05.013.
References 1. Abrams HL, Baum S, Pentecost MJ. Abrams’ angiography: interventional radiology. Lippincott Williams & Wilkins; 2006. 2. O’Neill SB, O’Connor OJ, Ryan MF, et al. Interventional radiology and the care of the oncology patient. Radiol Res Pract 2011;2011:160867. 3. Coldwell DM, Sewell PE. The expanding role of interventional radiology in the supportive care of the oncology patient: from diagnosis to therapy. Semin Oncol 2005;32(2):169e73. 4. Baggott BB, Long WB. Annular pancreas as a cause of extrahepatic biliary obstruction. Am J Gastroenterol 1991;86(2):224e6. 5. Didlake R, Haick AJ. Mirizzi’s syndrome. An uncommon cause of biliary obstruction. Am Surg 1990;56(4):268e9. 6. Allgaier HP, Schwacha H, Kleinschmidt M, et al. Ampullary hamartoma: a rare cause of biliary obstruction. Digestion 1999;60(5):497e500. 7. Thulin A. [Mirizzi syndrome. A rare cause of biliary tract obstruction]. Lakartidningen 1999;96(8):901e2. 8. Burke DR, Lewis CA, Cardella JF, et al. Quality improvement guidelines for percutaneous transhepatic cholangiography and biliary drainage. J Vasc Interv Radiol 2003;14(9 Pt 2):S243e6. 9. Saad WE, Wallace MJ, Wojak JC, et al. Quality improvement guidelines for percutaneous transhepatic cholangiography, biliary drainage, and percutaneous cholecystostomy. J Vasc Interv Radiol 2010;21(6):789e95. 10. O’Connor O, Buckley J, Maher M. Interventional radiology in oncology. Imaging in oncology. Springer; 2008. p. 493e511. 11. Mueller PR, van Sonnenberg E, Ferrucci Jr JT. Percutaneous biliary drainage: technical and catheter-related problems in 200 procedures. AJR Am J Roentgenol 1982;138(1):17e23.
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12. Rossi P, Bezzi M, Rossi M, et al. Metallic stents in malignant biliary obstruction: results of a multicenter European study of 240 patients. J Vasc Interv Radiol 1994;5(2):279e85. 13. Uberoi R, Das N, Moss J, et al. British Society of Interventional Radiology: Biliary Drainage and Stenting Registry (BDSR). Cardiovasc Interv Radiol 2012;35(1):127e38. 14. Uberoi R, Ettles DF, Birch PA. A cost saving technique for the introduction of biliary stents. Eur J Radiol 1995;20(1):75e6. 15. Lee M, Fanelli F, Haage P, et al. Patient safety in interventional radiology: a CIRSE IR checklist. Cardiovasc Interv Radiol 2012;35(2):244e6. 16. Ballinger AB, McHugh M, Catnach SM, et al. Symptom relief and quality of life after stenting for malignant bile duct obstruction. Gut 1994;35(4):467e70. 17. Burke DR, Lewis CA, Cardella JF, et al. Quality improvement guidelines for percutaneous transhepatic cholangiography and biliary drainage. Society of Cardiovascular and Interventional Radiology. J Vasc Interv Radiol 1997;8(4):677e81. 18. Kaufman JA, Lee MJ. Vascular and interventional radiology. Elsevier Health Sciences; 2013. p. 453e60. 19. Becker CD, Gl€ attli A, Maibach R, et al. Percutaneous palliation of malignant obstructive jaundice with the Wallstent endoprosthesis: followup and reintervention in patients with hilar and non-hilar obstruction. J Vasc Interv Radiol 1993;4(5):597e604. 20. Maccioni F, Rossi M, Salvatori FM, et al. Metallic stents in benign biliary strictures: three-year follow-up. Cardiovasc Interv Radiol 1992;15(6):360e6. 21. Maccioni F, Bezzi M, Gandini R, et al. [Metallic stents in benign biliary stenosis. A four-year follow-up]. La Radiologia Medica 1993;86(3):294e301. 22. Carrasco C, Zornoza J, Bechtel W. Malignant biliary obstruction: complications of percutaneous biliary drainage. Radiology 1984;152(2):343e6. 23. Nomura T, Shirai Y, Hatakeyama K. Bacteribilia and cholangitis after percutaneous transhepatic biliary drainage for malignant biliary obstruction. Dig Dis Sci 1999;44(3):542e6. 24. Nichols D, MacCarty R, Gaffey T. Cholangiographic evaluation of bile duct carcinoma. AJR Am J Roentgenol 1983;141(6):1291e4. 25. Yee AC, Ho CS. Complications of percutaneous biliary drainage: benign vs malignant diseases. AJR Am J Roentgenol 1987;148(6):1207e9. 26. Lyon SM, Terhaar O, Given MF, et al. Percutaneous embolization of transhepatic tracks for biliary intervention. Cardiovasc Interv Radiol 2006;29(6):1011e4. 27. Kessel D, Ray C. Transcatheter embolization and therapy. Springer Science & Business Media; 2010. p. 353e400.
Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013
Contents lists available at ScienceDirect
Clinical Radiology journal homepage: www.clinicalradiologyonline.net
A review of percutaneous transhepatic biliary drainage at a tertiary referral centre H. Asadi a, b, R. Hollingsworth a, K. Pennycooke a, P. Thanaratnam a, M. Given a, A. Keeling a, M. Lee a, * a
Interventional Radiology Service, Department of Radiology, Beaumont Hospital, Beaumont Rd, Beaumont, Dublin 9, Ireland b School of Medicine, Faculty of Health, Deakin University, Pigdons Road, Waurn Ponds, VIC 3216, Australia
art icl e i nformat ion Article history: Received 22 March 2016 Received in revised form 9 May 2016 Accepted 20 May 2016
AIM: To review percutaneous biliary drainage (PBD) procedures performed in Beaumont Hospital, Dublin, Ireland, over a 6-year period, to determine the 30-day morbidity and mortality. MATERIALS AND METHODS: A total of 119 patients undergoing 193 PBD procedures were identified over a 6 year period. Of the patients, 6.7% (eight patients) had stone disease, 63% (75 patients) had a malignancy, and the remainder were diagnosed with other conditions. Standard techniques of PBD and biliary stent insertion were applied, with 73 patients (61%) having same-day procedures and all undergoing gelfoam embolisation of percutaneous tracts. All patients received intravenous prophylactic antibiotics and intravenous hydration prior to PBD. RESULTS: The technical success rate was 97%, with a mean drop of 105 mmol/l between preand post-procedure bilirubin. Thirty-day mortality was 10.9% (13 deaths), with major and minor morbidities of 5% (six patients) and 7.6% (nine patients), respectively. Major complications included sepsis in two patients, major haemorrhage in two patients, and renal failure in two patients. Minor complications included infection in seven patients, bile leak causing selflimiting pain in one patient, and minor haemorrhage in one patient. CONCLUSION: The study confirms that PBD and stent insertion is a safe and effective technique in Beaumont Hospital, associated with an overall acceptable morbidity and mortality comparable with other studies. Ó 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Introduction Biliary obstruction may be due to benign, malignant, or iatrogenic diseases. The most common malignant cause of biliary obstruction is an underlying pancreatic neoplasm extrinsically compressing the distal bile duct. Other
* Guarantor and correspondent: M. Lee, Interventional Radiology Service, Department of Radiology, Beaumont Hospital, Beaumont Rd, Beaumont, Dublin 9, Ireland. Tel.: þ353 1 809 3000; fax: þ353 1 809 837 6982. E-mail address: [email protected] (M. Lee).
conditions include cholangiocarcinoma, as well as metastatic disease at the hepatic hilar nodes or in the peripancreatic nodes, causing obstructive jaundice from extrinsic pressure on the proximal or distal portions of the biliary tree.1e3 Benign diseases include inflammatory processes and stones as well as rare conditions, e.g., Mirizzi’s syndrome, along with benign tumours and iatrogenic or traumatic biliary injuries.4e7 A great majority of patients with biliary obstruction, in particular due to pancreatic neoplasms or stone disease, can be treated by endoscopic retrograde cholangiopancreatography (ERCP); however, those who fail ERCP, may require
http://dx.doi.org/10.1016/j.crad.2016.05.013 0009-9260/Ó 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013
e2
H. Asadi et al. / Clinical Radiology xxx (2016) e1ee5
percutaneous transhepatic biliary drainage (PTBD) to achieve adequate biliary decompression.1,2 PTBD is an effective method for the management of biliary abnormalities under imaging guidance using interventional radiology techniques, which involves sterile cannulation of a peripheral bile duct followed by guidewire and catheter positioning above the stricture.8,9 Subsequently, contrast material injection into an intra-hepatic bile duct will provide a cholangiogram, delineating the anatomy of the biliary tree, determining the location of obstruction, and helping to guide the intervention.2,9 Depending on the cholangiographic findings, placement of a catheter or stent may be considered to facilitate internal or external drainage of bile, allowing decompression of the biliary system.1,2,10 Apart from the primary underlying cause and the level of the biliary obstruction, different technical aspects of the interventional procedure, including the access, internal versus external biliary drainage, position and type of stent, tract embolisation and duration of drainage have all been investigated as factors that may influence the outcome of the percutaneous biliary drainage (PBD).11 PTBD is effective at relieving biliary obstruction; however, it has been associated with complications including sepsis, haemorrhage and localised infective, as well as inflammatory processes such as abscess, peritonitis, cholecystitis, and pancreatitis,2,12 with an overall 30-day in hospital mortality rate of approximately 20% in one recent study.13,14 The aim of the present study was to review PTBDs performed in a tertiary referral centre, Beaumont Hospital, Dublin, Ireland, and to assess technical success and 30 day morbidity and mortality rates.
Materials and methods As a retrospective audit, this study did not require approval from the institution’s ethics committee.
Concordant with the quality-improvement guidelines for PBD set out by the Society of Interventional Radiology (SIR) and the Cardiovascular Interventional Radiology Society of Europe (CIRSE),15 pre-procedural work-up also included liver function tests, coagulation profile, serum creatinine levels, and inflammatory markers. Abnormal laboratory parameters were optimised where necessary prior to the procedure. All patients were given pre-procedural prophylactic antibiotic coverage with 4.5 g of intravenous piperacillin/ tazobactam (Tazocin, Pfizer, Cork, Ireland) at least 1 hour prior to commencing the procedure. Patients were also adequately hydrated pre-procedure. The routine protocol required patients to receive 1 l of normal saline intravenously in the 12 hours before the procedure. All patients received conscious sedation and adequate analgesia with a combination of midazolam and fentanyl for the duration of the procedure in an incremental dose fashion depending on the patient’s clinical status. Using fluoroscopic guidance and the single puncture technique a 21 G fine-needle (Chiba, Cook, Bloomington, IN, USA) was used to gain access to a peripheral bile duct. A 0.01800 guidewire was used for initial access followed by a NeffSetÒ (Cook) and a 0.03500 J guidewire (Cook). A 0.03500 hydrophilic guidewire (Glidewire, Terumo, Shibuya-ku, Tokyo, Japan) was then used with the support of a 5 F KMP catheter (Cook) to cross the obstruction into the duodenum and a drainage catheter (Cook) or stent (Wallstent, BostonScientific, Marlborough, MA, USA, or Zimmon, Cook) was placed in the desired location depending on whether the patient was a surgical candidate or not. The percutaneous tract was then embolised with Gelfoam (Pfizer, New York City, NY, USA) torpedoes when the drainage catheter was removed, between the distal end of the percutaneous track and the biliary access point, either on the same day as initial PTBD or several days later if a single-stage procedure could not be performed.
Statistical analyses Data collection Retrospective review of a prospectively collected logbook from 2007e2013 discovered a total of 119 patients (67 male patients and 52 female patients) with an age range of 47 to 100 years (mean age of 70.6 years and SD of w11) who underwent 193 percutaneous biliary procedures. Technical success, complications, 30-day morbidity/mortality rates were extracted from the electronic medical records, review of chart and microfilm records, and anonymised. Subsequently the collated data were entered into an Excel (Microsoft, Redmond, WA, USA) spreadsheet.
Procedure and technique Pre-procedural work-up included cross-sectional imaging by magnetic resonance imaging (MRI), if hilar obstruction or computed tomography (CT), if low common bile duct obstruction to further characterise the underlying pathology in all patients.
SPSS (IBM, Armonk, NY, USA) and Rapidminer (RapidMiner, Cambridge, MA, USA) were used for data and statistical analyses.
Results On the pre-procedural imaging work-up it was shown that 43 patients (37%) suffered from cholelithiasis, choledocholithiasis, pancreatitis, and cholangitis or related complications, 75 patients (63%) had a malignant neoplastic condition, with 37/75 (49%) having a primary biliary, pancreatic, or hepatocellular malignancy; while the remainder were diagnosed with metastatic conditions (Electronic Supplementary Material, Table S1). Technical success was defined as the ability to complete all technical aspects of the procedure including crossing the lesion to provide internal drainage by stent or catheter. Three procedures (1.5%) failed technically as the obstructed
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lesions could not be crossed, but these patients were drained effectively by external drainage. Eighty-six (67 metal, nine plastic) stents were placed with eight patients receiving two metal stents. There were a total of 94 drains inserted, of which 75 were internaleexternal drains and the remainder were external drains only. Pre-procedural liver function tests demonstrated an average alkaline phosphatase of 724 IU/l (SD of 424 IU/l) and bilirubin of 200 mg/dl (SD of 147 mg/dl). The postprocedure average alkaline phosphatase (46l U/l SD of 298 IU/l) and serum bilirubin (158 mg/dl) decreased significantly by 37% (p<0.008) and 22.5% (p<0.01), respectively (Electronic Supplementary Material, Figs S1 and S2). The thirty-day post-procedure mortality was 10.9% (13 patients). In these latter cases, PTC was performed palliatively to improve quality of life in patients with symptoms of obstructive jaundice.16 The cause of death in all cases was determined to be underlying primary disease; 12 patients died due to complications of metastatic cancer and one due to complications of acute on chronic renal failure, which was not procedure related. Thirty-day morbidity was 12.6% (Table 1). Three patients in the study group had major haemorrhage. Ten patients in the present series were found having international normalised ratios (INRs) >1.5 at the time of procedure; however, the patient who eventually required multiple transfusions had in fact got an INR of 1.1 and bled from the primary inoperable ampullary adenocarcinoma on the background of severe pre- and post-procedural sepsis, which was unresponsive to antibiotic therapy. She eventually developed disseminated intravascular coagulopathy and passed away 7 days after the procedure. In Beaumont Hospital, the coagulation profile of the patients with an INR >1.5 is optimised with fresh frozen plasma prior to the procedure; however, for the sake of comparison with the BSIR audit with an unconventional INR reference of 1.3, it is worth mentioning that 31 patients in the present series had recorded INRs of 1.3 at the time of procedure with the remaining two patients, who suffered from major haemorrhage, requiring prolonged hospital stay, had INRs of just above 1.3. In addition, one patient in the series with a pre-procedure INR <1.3 suffered from a minor haemorrhage that did not require transfusion or prolonged hospital stay. One patient had a minor bile leak, which subsided with conservative management, and two of the present patients developed renal failure, which was defined as an increase in serum creatinine of >25% from baseline (Electronic
Table 1 Categorisation and incidence of the procedural morbidities. Complication
wPercentage
Sepsis
Minor 47% Major 13% 7% 13% Minor 7% Major 13%
Bile leak Renal failure Haemorrhage
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Supplementary Material, Appendix S1). Both of these patients had pre-existing sepsis prior to the procedure and the PTBD was performed after failed ERCP to drain the biliary system in an effort to improve sepsis. One patient developed acute-on-chronic failure, while the other developed acute renal failure, both of which were secondary to sepsis. Seven patients (6%) developed minor sepsis (Electronic Supplementary Material, Appendix S2). These patients had varying evidence of infection in the 10 days prior to the procedure, e.g., characterised by a mild temperature or minor increase in inflammatory markers, but did not meet the criteria for major sepsis. In the majority of cases, it is difficult to determine with any degree of certainty if sepsis was caused by the procedure itself or exacerbation of existing underlying infection present at the time of the procedure. Two patients developed major sepsis (Electronic Supplementary Material, Appendix S2). One patient required intensive care unit admission on two occasions postprocedure, eventually making a full recovery. Another became septic mid-procedure, causing the procedure to be aborted and rescheduled. As mentioned before, an additional two patients with renal failure also had major sepsis prior to the procedure, and therefore, were excluded from the analysis for procedural sepsis rate.
Discussion Most studies have shown that PTBD has a high technical success rate, with one recent study demonstrating a success rate >95%, but with a high 30-day mortality rate of 19.8% and significant morbidity of 34%.13 In comparison, in the present study, significantly lower mortality and morbidity rates of 10.9% and 12.6%, respectively, were demonstrated. The recent BSIR audit also reported that haemorrhage, sepsis, and renal failure were the most common major complications associated with the highest mortality risk, which is more or less consistent with the present findings from this series of patients.13 Complication rates vary amongst institutions and operators, which may be due to differences in patient status, operator experience, and technical challenges of the procedure. In general, complications may be classified into major and minor (Electronic Supplementary Material, Appendix S3), with the major complications classified as those that require hospital admission for an outpatient procedure, or those that cause an increase in the level of care or necessitate a prolonged stay for hospitalised patients, or lead to permanent unplanned sequelae or death.8,9,13,17 Conversely, minor complications may be classified as having no sequelae, necessitating minimal therapy, or short-stay hospital admission for observation.8,9,13,17 Major complications, such as haemorrhage, renal failure, and septicaemia, can be minimised with optimum patient management in the pre-procedural period. Interventions, such as appropriate pain management, prophylactic antibiotic administration, and fluid-replacement therapy, can help to reduce the complication rate.18
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Patient selection may also play a role in the wide range of factors important in complication rates and mortality, with a significant percentage of patients undergoing PTBD due to unresectable malignant disease. In the present study all patients who died in the 30-day post-procedural period, had an underlying diagnosis of malignancy, and obviously, in these instances the goal of PTBD is predominantly palliative to improve quality of life rather than being curative. It is worth noting that 12 of the 13 patients who died within 30 days of PBD had metastatic disease, and it may be worth evaluating life expectancy of these patients carefully before subjecting them to PBD. Patient compliance in the post-procedural period is also of paramount importance. Pain is the most common complication associated with PTBD and adequate analgesia should be administered to prevent the patient from tampering with biliary tubes. This can lead to biliary tube dislodgement and was the most documented chronic complication described in some studies.11 The latter can lead to an increased risk of biliary sepsis and peritonitis. Pre-procedural evaluation and preparation is important in identifying factors that may contribute to an increased complication rate. Patients undergoing PTBD procedures are often elderly, neutropenic, and have multiple comorbidities, and these secondary factors can contribute to a higher post-procedural complication rate. Overall, the incidence of complications has been reported to be higher in the patients suffering from malignant causes of obstruction. This is probably related to the rapid advancement of the primary disease and the potential coexisting treatment related immunosuppression; on the contrary, the mortality drastically decreases to approximately 16% accumulatively in a 3-year period post-procedural follow-up in those patients with benign conditions.12,19e21 In previous studies, antibiotic prophylaxis is an established prerequisite prior to the procedure and usually involves a combination of multiple agents or a broadspectrum antibiotic to achieve adequate coverage.8,13 Furthermore, in some studies the incidence of cholangitis in patients with underlying malignancy has been shown to be approximately 50% in total; in particular, it is twice as common in those with internal and external drainage than in those with external drainage alone.2,22 In addition, it has been shown that the longer the duration of PBD, the more likely the patient is to develop cholangitis.2,23 Infected bile has been detected in 25% to 36% of patients with malignant biliary obstruction,24 making pre-procedural administration of appropriate prophylactic antibiotics to this group of patients even more important; and overall, prophylactic antibiotic, including cover for Escherichia coli, Klebsiella, Enterococcus, Streptococcus, Enterobacter and Pseudomonas aeruginosa, is strongly recommended for all patients prior to biliary procedures, to minimise the risk of potential septic complications.2,10 Previously recommended prophylaxis regimens included ampicillin and gentamycin or cefotetan and mezocillin25; however, in Beaumont Hospital, the prophylactic antibiotic of choice is monotherapy with piperacillin/tazobactam (Tazocin, Pfizer, Cork, Ireland), which is a broad-spectrum
antibiotic that has Gram-negative, Gram-positive, and aerobic coverage, and importantly, high levels of biliary excretion. Given the fact that antibiotic prophylaxis is an important aspect of the pre-procedure protocol; it is felt to be a contributory factor in the low post-procedural sepsis rate with the major and minor infection rates being <2% and <6%, respectively. In comparison in the recent BSIR registry (Electronic Supplementary Material, Table S2), only approximately 50% of patients had received pre-procedural antibiotics, and no specific unified prophylactic regime was implemented. Given the above, the reported major and minor sepsis rates were 3.5% and 7.7%, respectively, in the BSIR registry.13 In addition, 59 patients in the BSIR registry had an INR reported to be >1.3, whereas only 29 patients in the present cohort had an INR >1.3.13 Optimisation of the patients’ coagulation status, combined with gelfoam embolisation of the access tract (Electronic Supplementary Material, Table S2),26 have both contributed significantly in reducing the present major peri-procedural haemorrhage rate to 1.5% compared to up to 3.5% reported in some large studies.26,27 Furthermore, the rate of biliary leak in the present study was negligible. In addition to the potential role in reducing the risk of haemorrhage, biliary tract embolisation from the access site to skin level has been correlated to a reduced incidence of bile leak, and a reduction in post-procedural pain experienced by patients26,27 Overall, since the quality improvement guidelines for PBD established by CIRSE15 have been implemented in Beaumont Hospital with almost 100% compliance, each PTBD patient was optimised in the pre-procedural period with prophylactic antibiotics, adjustment of the coagulation profile where necessary, IV hydration before the procedure, and access tract embolisation after the procedure. These factors most likely played a significant role in the relative improvement of patient outcomes with decreased 30-day morbidity and mortality. This study illustrates that, overall, PBD is an effective technique in improving liver function and reducing bilirubin levels and can be performed safely by experienced operators, with acceptable morbidity and mortality, and successful symptomatic relief. Implementing current recommended practice guidelines from CIRSE helps to decrease the potential morbidity and mortality associated with the procedure, and it is likely of benefit if these procedures are centralised in tertiary referral centres to increase subspecialty experience and enhance the ability to deal with possible complications.
Limitations The present study was conducted at a tertiary referral centre and a teaching hospital, with four experienced operators performing the procedures over a 6 year period; therefore, the results may not be generalised to other institutions with different level of expertise. In addition, a relatively high proportion of patients included in this study presented with benign causes of obstruction, which can potentially skew the final results. Other limitations of the
Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013
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study include its retrospective design, making a comprehensive assessment of all relevant clinical and biochemical factors almost impossible, as well as its relatively small number of cases, influencing the validity of the statistical comparison.
Appendix A. Supplementary data Supplementary data related to this article can be found at http://dx.doi.org/10.1016/j.crad.2016.05.013.
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Please cite this article in press as: Asadi H, et al., A review of percutaneous transhepatic biliary drainage at a tertiary referral centre, Clinical Radiology (2016), http://dx.doi.org/10.1016/j.crad.2016.05.013