ORIGINAL ARTICLE
Drainage-related Complications in Percutaneous Transhepatic Biliary Drainage An Analysis Over 10 Years Simon Nennstiel, MD,* Andreas Weber, MD,* Gu¨nter Frick, PhD,w Bernhard Haller, PhD,z Alexander Meining, MD,* Roland M. Schmid, MD,* and Bruno Neu, MD*
W
catheters has been a highly valuable therapy of choice over years. However, the introduction of different techniques, especially for the palliation of malignant biliary strictures, such as the percutaneous placement of metal stents,2 the balloon-enteroscopy ERC (in the case of Roux-Y anatomy),3 endoscopic ultrasound–guided biliary drainage (EUS-BD),4 or rendezvous techniques combining PTBD and ERC,5 have led to a decrease in PTBD therapies in recent years. The reason for this regression is a considerably high incidence of interventional PTBD complications, especially during the creation of the percutaneous tract (between 9% and 61%; PTBD-related mortality is 6%),6–15 in addition to patient discomfort and reduced quality of life ascribable to drainage-related complications, for example, occlusion of drainage, cholangitis, dislocation of drainage, and bile leakage.6–8,16–19 Despite the introduction of these novel techniques for biliary decompression, PTBD still plays a significant role, especially in the palliation of biliary malignancies and endoscopically inaccessible bile ducts. Therefore, there is a need for improvement in the drainage complication rates, to offer patients both an effective and low-complicative treatment. Although numerous studies have covered PTBD procedure-related problems, there is a lack of data concerning drainage-related complications. Authors have reported that approximately 20% to 77% of patients treated with PTBD have been affected by complications6,17–19; however, drainage complications were not the main issue of these publications. Furthermore, the data are often limited by the number of patients and on the observation period. The objective of the present retrospectively designed study was to assess complication rates, particularly the risk factors for occlusion and cholangitis, during percutaneous transhepatic biliary treatment in the long-term follow-up.
Received for publication May 5, 2014; accepted November 10, 2014. From the *II. Medizinische Klinik; wInstitut fu¨r klinische Chemie und Pathobiochemie; and zInstitut fu¨r Medizinische Statistik und Epidemiologie, Klinikum rechts der Isar der Technischen Universita¨t Mu¨nchen, Mu¨nchen, Germany. The authors declare that they have nothing to disclose. Reprints: Bruno Neu, MD, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universita¨t Mu¨nchen, Ismaninger Str. 22, Mu¨nchen 81675, Germany (e-mail: [email protected]). Copyright r 2014 Wolters Kluwer Health, Inc. All rights reserved.
The current study includes 385 patients who underwent percutaneous transhepatic therapy between June 1, 1997, and May 31, 2007, in the endoscopic department at the II. Medizinische Klinik, Klinikum rechts der Isar, Technische Universita¨t Mu¨nchen, a tertiary (referral center for PTBDs) hospital in Germany. The patients were identified by analyzing the hospital’s endoscopic database, hospital charts, and cholangiograms. The clinical records of all included patients were reviewed from the initial insertion to the removal of the PTBD, or to the patient’s death. In addition, the patients, their relatives, and family practitioners were directly contacted by telephone to obtain updated information (at the date of data acquisition).
Background: Procedure-related complications of percutaneous transhepatic biliary drainage (PTBD) have been well documented in the literature. However, relatively restricted data are available concerning drainage-related complication rates in long-term PTBD therapy. The present retrospective study evaluated the extent and the nature of drainage complications during PTBD therapy and associated risk factors for these complications. Patients and Methods: Between June 1997 and May 2007, a total of 385 patients with PTBD were identified by analyzing the PTBD database and hospital charts, with a total of 2468 percutaneous biliary drainages being identified. Results: Among the identified patients, 243 (63%) had malignant and 142 (37%) had benign bile duct strictures. At least 1 drainagerelated complication was observed in 40% of the patients. With respect to the total number of drains, prosthesis complications occurred in 23%. Occlusion, dislocation, and cholangitis were the most common complications observed during PTBD therapy. Risk factors for cholangitis and occlusion were malignant disease, prior occurrence of complications, and bilateral drainage. Proximal stenosis of the biliary system was close to significant. Conclusions: Drainage-related complications are a major problem in PTBD therapy. The risk factors for occlusion and cholangitis discovered in this study can help to refine individual strategies to reduce the rate of these drainage complications. Key Words: percutaneous transhepatic biliary drainage, PTBD, biliary drainage, cholangitis, occlusion of biliary drainage
(J Clin Gastroenterol 2015;49:764–770)
henever there is a need for biliary drainage in the case of benign or malignant stricture of the bile ducts, endoscopic retrograde cholangiography (ERC) is the intervention of choice. However, ERC may fail in 5% to 10% of the cases because of postsurgical anatomy or because of an inaccessible ampulla caused by gastric outlet obstruction or local tumor growth.1 In these cases, percutaneous transhepatic biliary drainage (PTBD) with plastic
PATIENTS AND METHODS
764 | www.jcge.com J Clin Gastroenterol Volume 49, Number 9, October 2015 Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
J Clin Gastroenterol
Volume 49, Number 9, October 2015
The criteria for the 385 patients included in this analysis were: insertion of PTBD as a result of benign/malignant obstruction of the bile ducts, and performance of initial insertion of PTBD and subsequent interventions/routine exchanges in our clinic. In these 385 patients, a total of 2468 PTBD drainages were altogether inserted during the PTBD treatment between June 1, 1997 and May 31, 2007 (a median of 4 drainages per patient; range, 1 to 113 drainages per patient). All of the PTBD interventions, including initial insertions (n = 467), routine exchanges, and interventions such as dilatation of the percutaneous tract or percutaneous stone removal were carried out in the endoscopic department at the Technische Universita¨t Mu¨nchen. PTBDs were primarily analyzed for the occurrence of drainage-related complications. Therefore, archived hospital documentation was examined with respect to symptoms (eg, fever, pain, icterus), laboratory parameters (cholestasis, inflammatory parameters), and PTBD reports in each case at the time of every admission to the hospital/exchange of drainage that indicated drainage complication. In addition, the following information was recorded about each patient, if necessary, at the time of each PTBD exchange: age, sex, genesis of the biliary stricture (benign/ malignant), location of the biliary stricture (proximal = intrahepatic, including hilar strictures, or distal = subhilar),
Drainage-related Complications in PTBD
size of drainage removed/inserted, time of occurrence of complication after last exchange, total time of PTBD therapy, prior complication, and location of PTBD (right/ left/both sides).
Definitions of Drainage-related Complications Complications of PTBD can be distinguished as procedure-related complications or drainage-related complications. Procedure-related complications and appropriate definitions are described by Weber et al.11 In this study, an event was stated as a drainage-related complication when a patient required medical treatment as a result of the PTBD, at least 48 hours after the last intervention. The interval of 48 hours was chosen to exclude complications caused by the prior intervention, such as cholangitis, bleeding, pain, or dislocation/leakage due to insufficient maturation of the percutaneous biliary tract after interventions. In our data, treatment with 191 drainages was 1 drainage complication. A total of 64% of all complications occurred during the first 30 days, 23% during the second month, and 13% past the second month after the last PTBD intervention. Regarding the most frequent drainage-related complications, occlusion and cholangitis are factors that could be prevented. The statistical analysis of 253 cases of occlusion and cholangitis presented different risk factors for occlusion and cholangitis (Table 3): Malignant disease (P < 0.001) with a 2.7 times higher risk compared with benign disease; CI, 1.79-4.10.
TABLE 3. Risk Factors for the Development of Occlusion and Cholangitis During PTBD Therapy (Multivariate Analysis)
Factors Age (< 68*; Z68*) Sex (male; female) Genesis of bile duct obstruction (benign; malignant) Location of bile duct obstruction (proximal; distal) Size of drainage (< 16 Fr*; Z16 Fr*) Time of occurrence of dysfunction after initial insertion (< 196 d*; Z196 d*) Internal drainage of PTBD (no; yes) Prior dysfunction (no; yes) Overall duration of PTBD therapy (< 593 d*; Z593 d*) PTBD from the right vs. left vs. both sides Right vs. both sides Left vs. both sides Left vs. right
Significance (P)
Odds Ratio
95% CI for Odds Ratio
0.674 0.492 < 0.001 0.0501 < 0.001 0.103
0.94 0.87 2.71 0.70 1.79 1.44
0.68-1.28 0.60-1.28 1.79-4.10 0.49-1.00 1.31-2.44 0.93-2.23
0.489 < 0.001 0.121
1.39 2.60 1.53
0.55-3.54 1.72-3.94 0.89-2.62
0.025 0.008 0.071
0.59 0.25 0.43
0.37-0.94 0.09-0.69 0.17-1.07
*Median split values. CI indicates confidence interval; PTBD, percutaneous transhepatic biliary drainage.
Copyright
r
2014 Wolters Kluwer Health, Inc. All rights reserved.
www.jcge.com |
Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
767
J Clin Gastroenterol
Nennstiel et al
Yamakawa size Z16 CH (P < 0.001) with a 1.8 times increased risk compared with catheter size
Drainage-related Complications in Percutaneous Transhepatic Biliary Drainage An Analysis Over 10 Years Simon Nennstiel, MD,* Andreas Weber, MD,* Gu¨nter Frick, PhD,w Bernhard Haller, PhD,z Alexander Meining, MD,* Roland M. Schmid, MD,* and Bruno Neu, MD*
W
catheters has been a highly valuable therapy of choice over years. However, the introduction of different techniques, especially for the palliation of malignant biliary strictures, such as the percutaneous placement of metal stents,2 the balloon-enteroscopy ERC (in the case of Roux-Y anatomy),3 endoscopic ultrasound–guided biliary drainage (EUS-BD),4 or rendezvous techniques combining PTBD and ERC,5 have led to a decrease in PTBD therapies in recent years. The reason for this regression is a considerably high incidence of interventional PTBD complications, especially during the creation of the percutaneous tract (between 9% and 61%; PTBD-related mortality is 6%),6–15 in addition to patient discomfort and reduced quality of life ascribable to drainage-related complications, for example, occlusion of drainage, cholangitis, dislocation of drainage, and bile leakage.6–8,16–19 Despite the introduction of these novel techniques for biliary decompression, PTBD still plays a significant role, especially in the palliation of biliary malignancies and endoscopically inaccessible bile ducts. Therefore, there is a need for improvement in the drainage complication rates, to offer patients both an effective and low-complicative treatment. Although numerous studies have covered PTBD procedure-related problems, there is a lack of data concerning drainage-related complications. Authors have reported that approximately 20% to 77% of patients treated with PTBD have been affected by complications6,17–19; however, drainage complications were not the main issue of these publications. Furthermore, the data are often limited by the number of patients and on the observation period. The objective of the present retrospectively designed study was to assess complication rates, particularly the risk factors for occlusion and cholangitis, during percutaneous transhepatic biliary treatment in the long-term follow-up.
Received for publication May 5, 2014; accepted November 10, 2014. From the *II. Medizinische Klinik; wInstitut fu¨r klinische Chemie und Pathobiochemie; and zInstitut fu¨r Medizinische Statistik und Epidemiologie, Klinikum rechts der Isar der Technischen Universita¨t Mu¨nchen, Mu¨nchen, Germany. The authors declare that they have nothing to disclose. Reprints: Bruno Neu, MD, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universita¨t Mu¨nchen, Ismaninger Str. 22, Mu¨nchen 81675, Germany (e-mail: [email protected]). Copyright r 2014 Wolters Kluwer Health, Inc. All rights reserved.
The current study includes 385 patients who underwent percutaneous transhepatic therapy between June 1, 1997, and May 31, 2007, in the endoscopic department at the II. Medizinische Klinik, Klinikum rechts der Isar, Technische Universita¨t Mu¨nchen, a tertiary (referral center for PTBDs) hospital in Germany. The patients were identified by analyzing the hospital’s endoscopic database, hospital charts, and cholangiograms. The clinical records of all included patients were reviewed from the initial insertion to the removal of the PTBD, or to the patient’s death. In addition, the patients, their relatives, and family practitioners were directly contacted by telephone to obtain updated information (at the date of data acquisition).
Background: Procedure-related complications of percutaneous transhepatic biliary drainage (PTBD) have been well documented in the literature. However, relatively restricted data are available concerning drainage-related complication rates in long-term PTBD therapy. The present retrospective study evaluated the extent and the nature of drainage complications during PTBD therapy and associated risk factors for these complications. Patients and Methods: Between June 1997 and May 2007, a total of 385 patients with PTBD were identified by analyzing the PTBD database and hospital charts, with a total of 2468 percutaneous biliary drainages being identified. Results: Among the identified patients, 243 (63%) had malignant and 142 (37%) had benign bile duct strictures. At least 1 drainagerelated complication was observed in 40% of the patients. With respect to the total number of drains, prosthesis complications occurred in 23%. Occlusion, dislocation, and cholangitis were the most common complications observed during PTBD therapy. Risk factors for cholangitis and occlusion were malignant disease, prior occurrence of complications, and bilateral drainage. Proximal stenosis of the biliary system was close to significant. Conclusions: Drainage-related complications are a major problem in PTBD therapy. The risk factors for occlusion and cholangitis discovered in this study can help to refine individual strategies to reduce the rate of these drainage complications. Key Words: percutaneous transhepatic biliary drainage, PTBD, biliary drainage, cholangitis, occlusion of biliary drainage
(J Clin Gastroenterol 2015;49:764–770)
henever there is a need for biliary drainage in the case of benign or malignant stricture of the bile ducts, endoscopic retrograde cholangiography (ERC) is the intervention of choice. However, ERC may fail in 5% to 10% of the cases because of postsurgical anatomy or because of an inaccessible ampulla caused by gastric outlet obstruction or local tumor growth.1 In these cases, percutaneous transhepatic biliary drainage (PTBD) with plastic
PATIENTS AND METHODS
764 | www.jcge.com J Clin Gastroenterol Volume 49, Number 9, October 2015 Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
J Clin Gastroenterol
Volume 49, Number 9, October 2015
The criteria for the 385 patients included in this analysis were: insertion of PTBD as a result of benign/malignant obstruction of the bile ducts, and performance of initial insertion of PTBD and subsequent interventions/routine exchanges in our clinic. In these 385 patients, a total of 2468 PTBD drainages were altogether inserted during the PTBD treatment between June 1, 1997 and May 31, 2007 (a median of 4 drainages per patient; range, 1 to 113 drainages per patient). All of the PTBD interventions, including initial insertions (n = 467), routine exchanges, and interventions such as dilatation of the percutaneous tract or percutaneous stone removal were carried out in the endoscopic department at the Technische Universita¨t Mu¨nchen. PTBDs were primarily analyzed for the occurrence of drainage-related complications. Therefore, archived hospital documentation was examined with respect to symptoms (eg, fever, pain, icterus), laboratory parameters (cholestasis, inflammatory parameters), and PTBD reports in each case at the time of every admission to the hospital/exchange of drainage that indicated drainage complication. In addition, the following information was recorded about each patient, if necessary, at the time of each PTBD exchange: age, sex, genesis of the biliary stricture (benign/ malignant), location of the biliary stricture (proximal = intrahepatic, including hilar strictures, or distal = subhilar),
Drainage-related Complications in PTBD
size of drainage removed/inserted, time of occurrence of complication after last exchange, total time of PTBD therapy, prior complication, and location of PTBD (right/ left/both sides).
Definitions of Drainage-related Complications Complications of PTBD can be distinguished as procedure-related complications or drainage-related complications. Procedure-related complications and appropriate definitions are described by Weber et al.11 In this study, an event was stated as a drainage-related complication when a patient required medical treatment as a result of the PTBD, at least 48 hours after the last intervention. The interval of 48 hours was chosen to exclude complications caused by the prior intervention, such as cholangitis, bleeding, pain, or dislocation/leakage due to insufficient maturation of the percutaneous biliary tract after interventions. In our data, treatment with 191 drainages was 1 drainage complication. A total of 64% of all complications occurred during the first 30 days, 23% during the second month, and 13% past the second month after the last PTBD intervention. Regarding the most frequent drainage-related complications, occlusion and cholangitis are factors that could be prevented. The statistical analysis of 253 cases of occlusion and cholangitis presented different risk factors for occlusion and cholangitis (Table 3): Malignant disease (P < 0.001) with a 2.7 times higher risk compared with benign disease; CI, 1.79-4.10.
TABLE 3. Risk Factors for the Development of Occlusion and Cholangitis During PTBD Therapy (Multivariate Analysis)
Factors Age (< 68*; Z68*) Sex (male; female) Genesis of bile duct obstruction (benign; malignant) Location of bile duct obstruction (proximal; distal) Size of drainage (< 16 Fr*; Z16 Fr*) Time of occurrence of dysfunction after initial insertion (< 196 d*; Z196 d*) Internal drainage of PTBD (no; yes) Prior dysfunction (no; yes) Overall duration of PTBD therapy (< 593 d*; Z593 d*) PTBD from the right vs. left vs. both sides Right vs. both sides Left vs. both sides Left vs. right
Significance (P)
Odds Ratio
95% CI for Odds Ratio
0.674 0.492 < 0.001 0.0501 < 0.001 0.103
0.94 0.87 2.71 0.70 1.79 1.44
0.68-1.28 0.60-1.28 1.79-4.10 0.49-1.00 1.31-2.44 0.93-2.23
0.489 < 0.001 0.121
1.39 2.60 1.53
0.55-3.54 1.72-3.94 0.89-2.62
0.025 0.008 0.071
0.59 0.25 0.43
0.37-0.94 0.09-0.69 0.17-1.07
*Median split values. CI indicates confidence interval; PTBD, percutaneous transhepatic biliary drainage.
Copyright
r
2014 Wolters Kluwer Health, Inc. All rights reserved.
www.jcge.com |
Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
767
J Clin Gastroenterol
Nennstiel et al
Yamakawa size Z16 CH (P < 0.001) with a 1.8 times increased risk compared with catheter size
