Abstract
Background
Complication rates in percutaneous transhepatic biliary drainage (PTBD) are non-uniform and vary considerably. In addition, the impact of peri-procedural risk factors is under-investigated.
Purpose
To compare success and complication rates of PTBD in patients with and without accompanying technical risk factors.
Material and Methods
A single-center retrospective study was conducted from January 2004 to December 2016. Patients receiving PTBD due to biliary obstruction or biliary leakage were included. Technical risk factors (non-distended bile ducts, ascites, obesity, anasarca, non-compliance) were assessed. Complications were classified according to the Society of Interventional Radiology.
Results
In total, 372 patients were included (57.3% men, 42.7% women; mean age = 66 years). Overall, 466 PTBDs were performed. Of the patients, 70.1% presented with malignancy and biliary obstruction; 26.8% had benign biliary obstruction; 3.1% had biliary leakage. Technical risk factors were reported in 57 (15.3%) patients. Overall technical success of initial PTBD was 98.7%, primary technical success was 97.9%. In patients with non-dilatated bile ducts, primary technical success was 68.2%. Overall complication rate was 15.0% (8.1% major complications, 6.9% minor complications). Neither major nor minor complications were more frequent in patients with technical risk factors (P > 0.05). In left-sided PTBD, hemorrhage was more frequent (P = 0.015). Patients with malignancy were significantly more affected by drainage-related complications (P = 0.004; odds ratio = 2.03). The mortality rate was 0.5% (n = 2).
Conclusion
PTBD is a safe and effective method for the treatment of biliary obstruction and biliary leaks. Complication rates are low, even in procedures with risk factors.
Introduction
Percutaneous transhepatic biliary drainage (PTBD) is favorably employed if endoscopic retrograde cholangiopancreatography (ERCP) is not successful or technically not possible. In this setting, PTBD is the gold standard of practice (1). Recent studies underlined comparable performance status and complication rates of PTBD and ERCP (2–6). Typical complications related to PTBD include hemorrhage, cholangitis, sepsis, peritoneal biliary leakage, and perforation (6). Though PTBD has been evaluated extensively, reported complication rates are non-uniform and vary considerably (7,8). Furthermore, the impact of peri-procedural risk factors (e.g. presence of ascites) is under-investigated. This prompted us to retrospectively evaluate our long-term clinical outcome and complication rates in PTBD.
Material and Methods
In this retrospective single-center study, patients treated with PTBD between January 2004 and December 2016 were reviewed. All procedures performed were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments. This clinical observational study was approved by the institutional ethics committee and need for written informed consent was waived due to its retrospective nature (Ethikkommission Universität Bonn). Inclusion criteria encompassed PTBD placement due to bile duct obstruction or biliary leakage. Patients who received hepatic drainage due to biliary abscess or biloma were excluded from the study cohort (Fig. 1).
Inclusion and exclusion criteria of the study cohort.
All patients gave written informed consent to the procedure and the use of procedural data before the intervention.
Procedure
For diagnostic workup and procedural planning, all patients received an abdominal ultrasound (± abdominal computed tomography [CT]/magnetic resonance imaging) before the intervention. PTBD was performed in a sterile Seldinger technique under fluoroscopy guidance (Allura; Philips N.V., The Netherlands) (Fig. 2). A right-sided approach was preferred. After local anesthesia (2% Scandicain) and skin incision, fine needle puncture was performed using a 22-G puncture needle (Chiba needle; Boston Scientific, Marlborough, MA, USA). In case of opacification of a central bile duct, a second needle was introduced to cannulate a peripheral bile duct (double needle technique) (9,10); in case of opacification of a peripheral bile duct, wire advancement was performed via the same needle. After successful cannulation of a suitable bile duct, a flexible 0.018-inch microwire was introduced, allowing to exchange for a 4-Fr introducer sheath. In case the primary internalization of PTBD was intended, a 0.035-inch hydrophilic guidewire combined with a short 4-Fr multipurpose catheter were used for manipulation. Introduction of external and internal drainages was typically performed via a stiff guidewire.
Fluoroscopic-guided PTBD with implantation of an internal/external drainage. Postoperative status after partial duodenopancreatectomy (origin: pancreatic adenocarcinoma). (a) Cholangiogram after puncture of a peripheral bile duct in the two-needle technique. Delineation of a distended bile tree. (b) Advancement of the 7-Fr drainage to enteral. (c) Successful decompression of the bile duct system.
Technical success was defined as successful catheterization of the biliary system followed by percutaneous stent or tube placement (9,11). Non-distended bile ducts, ascites, obesity, anasarca, and non-compliance were considered technical risk factors (1,6,7,10,12,13). Obesity was defined as body mass index (BMI) >35 kg/m2. Patients with ascites had free fluid in all four quadrants. Patients with anasarca had circumferential abdominal fat stranding of the subcutaneous tissue in pre-interventional CT.
Complications
Complications were classified according to the Society of Interventional Radiology (SIR) (14).
Drainage-related complications
Drainage-related complications were defined as complications in the course of treatment by PTBD, which led to a premature presentation of the patient before routine change, e.g. occlusion/obstruction of the drainage, dislocation, bile or blood leakage, pain, material defect, or local infection (15).
Statistical analyses
Statistical analyses were performed using commercially available statistical software SPSS version 25 (IBM Corp., Armonk, NY, USA). Binary logistic regression analysis was used to determine the odds ratio (OR) in drainage-related complications (95% confidence interval [CI]). Mixed linear models were used for estimation of differences in laboratory parameters over time between the two groups. The chi-square test was used to determine P values. A P value <0.05 was considered statistically significant.
Results
A total of 372 patients (213 men, 159 women; mean age = 66.0 years; age range = 17–100 years) were included. Patient characteristics are given in Table 1. Underlying malignant disease (70.1%) was more common than benign disease (29.9%).
Characterization of the study cohort and technical success.
Values are given as n (%) or median (range). Characterization of the study cohort includes age distribution, sex, and pathogenesis of biliary obstruction. Percentage distribution is based on a total of 372 procedures (benign: 115, malignant: 269). A total of 128 benign diseases and 310 malignant diseases is due to repetitive count, reflecting multimorbidity of the patient cohort. Technical success depends on the access route. In addition, the overall complications were differentiated according to access route and internal/external drainage.
Overall, 1708 interventions were performed; these consisted of 466 (27.3%) PTBD placements and 1242 (72.7%) control examinations. In 902 of 1242 controls (72.6%), revisions were performed with exchange of drainage catheter; additionally, 168 dilatations of biliary stenosis were performed.
In a total of 234 of 466 (50.2%) PTBD placements, ERCP had been performed before PTBD without success (98 preoperated patients; 136 non-preoperated patients). In two cases, it was not clear from the long-term retrospective data whether a direct indication for PTBD had previously been made or whether ERCP had previously been performed. In the majority of cases, unsuccessful ERCP was due to prolonged cannulation times (e.g. altered bile duct anatomy due to congenital aberration or previous surgery), advanced malignant disease involving the duodenal C or papilla, or duodenal stenosis. In 232 of 466 (49.8%) cases, PTBD was chosen as the primary therapeutic measure, thereof 47.4% due to prior operation (n = 110).
Overall technical success during PTBD placement was achieved in 98.7% procedures. In 97.9% of procedures, PTBD placement was achieved in the first attempt (in the second intervention: 9 [1.9%] procedures; in the third intervention: 1 [0.2%] procedure). In 80.2% of procedures, PTBD was introduced via the right (left = 19.0%, bilateral = 0.8%). Primary technical success for left-sided PTBD was 95.8%; in 3 (4.2%) procedures of left-sided PTBD, a second intervention was required.
PTBD placement led to a significant reduction of cholestasis. Within the first five days, bilirubin levels decreased by 48.0%; within 30 days, bilirubin levels decreased by 75%.
Technical risk factors were present in 57 patients. In this subgroup, primary technical success was 91.2% (in comparison to the non-risk factor group; P < 0.05). In patients with non-dilated biliary ducts (n = 16), the primary technical success rate was 68.2% (in comparison to the distended group; P < 0.05). In procedures with ascites (n = 34), BMI >35 kg/m2 (n = 3), anasarca (n = 1), non-compliance (n = 1), and combined risk factors (n = 2), primary technical success was 93.4%.
In 466 primary PTBD placements, 38 (8.1%) major complications and 32 (6.9%) minor complications were noted. Overall, during the course of PTBD treatment, 226 (13.2%) drainage-related complications were reported.
Most frequent major complications were hemorrhage (n = 9, 1.9%), followed by cholangiosepsis (n = 7, 1.5%) and intrahepatic abscess (n = 5, 1.1%). Most frequent minor complications were intrahepatic/subcapsular hematoma (n = 11, 2.4%) (Fig. 3), biloma (n = 7, 1.5%), and hemobilia (n = 6, 1.3%) (Table 2). The etiology of disease, lack of biliary duct dilatation, peri-interventional ascites, emergency indication of PTBD, and peri-procedural dilatation of the stenosis had no impact on the incidence of major or minor complications. Hemorrhage was more frequent in left-sided PTBD (P = 0.015). Complications were not increased in procedures with technical risk factors (all P > 0.05). The incidence of complications was also not increased in procedures where emergency PTBD placements (7.1%) were performed or in procedures where dilatations (14.6%) were performed.
Pseudoaneurysm of the right hepatic artery after fluoroscopic-guided PTBD. (a) Angiogram and (b) superselective angiogram after PTDB revealing a pseudoaneurysm (arrow) of a branch of the right hepatic artery in the course of the implanted drainage. (c) Angiogram after successful coiling of the feeding branch.
Complication rates over time.
Values are given as n or n (%). Complication rates over time encompassing major and minor complications. Complications were classified according to Society of Interventional Radiology (SIR) Clinical Practice Guidelines (14).
Most frequent drainage-related complications were partial dislocation of biliary drainage catheters (n = 85, 5.0%), biliary leakage (n = 72, 4.2%), and catheter occlusion (n = 27, 1.6%) (Table 3). Partial dislocation of drainage was more frequent in patients where the drainage was not advanced into the duodenum/intestine (OR = 1.953; P = 0.026). In general, patients with malignant etiology of disease were significantly more affected by drainage-related complications (OR = 2.03; P = 0.004) than patients with benign etiology of disease. Partial dislocation of the drainage (OR = 2.44; P = 0.017) was significantly more frequent in malignant underlying etiology than in benign etiology of disease. The same phenomenon could be seen in drainages that were not advanced into the duodenum/intestine (OR = 0.51; P = 0.026).
Drainage-related complications in benign and malignant diseases.
Values are given as n or mean ± SD. Drainage-related complications in benign and malignant diseases with corresponding P value, OR, and 95% CI. P values in bold indicate statistically significant results.
CI, confidence interval; OR, odds ratio; SD, standard deviation.
On average, biliary drainages remained in situ for 81 days (median = 19 days; range = 1−2214 days). In two patients, PTBD led to complications that ended fatally. The mortality rate was 0.5%. One patient developed an arterio-biliary fistula and the other patient developed a porto-biliary fistula. Both fistulas could be successfully occluded by coil embolization. Both patients died within five days of embolization due to renal/hepatic failure.
Discussion
PTBD effectively allows for biliary drainage, restoration of biliary flow, and treatment of biliary leakage in both benign and malignant biliary diseases. Recent studies underline comparable performance and complication rates of PTBD to ERCP (2–6). However, data regarding the technical success and complication rates in PTBD cases with accompanying risk factors are lacking. This caused us to retrospectively evaluate our in-house PTBD data.
The majority of patients referred to our department for PTBD placement experienced malignant disease (70.1% vs. 29.9%), predominantly due to extracanicular compression (45.0%). In the present study, PTBD was primarily performed following ERCP failure, reflecting PTBD as the therapy of choice in this setting. ERCP failure before PTBD was reported in 234 of 372 of our patients (98 preoperated patients, 136 patients without preoperation); in the literature, the ERCP failure rate is up to 10% (6,7,16). PTBD was successful in all these patients. In considerably fewer procedures, PTBD was performed without a prior ERCP attempt (136 patients in total, 110 preoperated patients, 26 without preoperation).
The reported technical success rates of ERCP are in the range of 90%–95% (17–19). In comparison, in the present study, the overall technical success rate of PTBD was 98.7%, with a primary technical success rate of 97.9%; these findings are in line with the abovementioned results of previous PTBD studies. However, in procedures with non-dilated biliary ducts, the primary technical success rate was only 68.2%. A possible explanation for the low success rates is the low number of cases with non-dilated bile ducts included in our study. Studies with higher rates of non-dilated bile ducts (39.9% vs. 5.6%) showed a significantly higher primary technical success (92.1% vs. 68.2%) (1). Thus, as supported by previous data (11,20,21), technical success rates of PTBD are at least similar to ERCP, albeit more dependent on the degree of biliary distension. Technical success rates of ERCP do not differ between patients with and without dilatation, as biliary distension is not a factor influencing catheterization of biliary ducts in ERCP. Therefore, one could assume ERCP is superior to PTBD in non-distended procedures. However, most patients receiving PTBD with non-dilatated biliary ducts require intervention due to postoperative biliary leakage; for this indication, PTBD has been shown to be superior to ERCP, even in patients technically treatable with ERCP (22). In the present study, PTBD placement led to a significant reduction of cholestasis. Within the first five days, bilirubin levels decreased by 48.0%; within 30 days, bilirubin levels decreased by 75%, in line with previous literature (10,23).
Reported complication rates of PTBD vary severely and are in the range of 9%–61% (17), which may be explained by the non-uniform definition and reporting of peri-interventional complications (22,24).
To allow for comparability, complications were classified according to previously described criteria (6) and the SIR criteria (14). In the authors’ opinion, the SIR scoring system differentiates more clearly between minor and major criteria. This allows for easier comparison with older studies.
Though the type of reported complications was similar in previous comparable PTBD studies (e.g. hemorrhage, cholangiosepsis, and intrahepatic abscess), both higher and lower complication rates can be found in previous literature (1,6,10). Compared to Weber et al., who did not employ the standard SIR criteria, the rate of complications was higher in the current study (overall: 15.0 vs. 9.3%, major: 8.1 vs. 4.1%, minor 6.9 vs. 5.3%) (6). Our patient cohort composition differed in comparison to the aforementioned PTBD study, in that more patients with malignancies were included (70.1% vs. 63.7%). The rate of complications was increased in these patients; patients with malignancies frequently present with impaired general condition (25,26), which may explain the elevated complication rate in this subgroup. The current cohort also differed in the rate of patients presenting with dilated biliary ducts (94.4% vs. 68.7%). In comparison to another previously reported large study cohort (10), the current complication rate was lower (overall: 15.0 vs. 33.9%; major: 8.1 vs. 7.9%; minor: 6.9 vs. 26%), highlighting the necessity of uniform complication reporting.
Non-dilated biliary ducts are typically more difficult to puncture and catheterize, leading to longer interventions with potentially more complications. Although the primary technical success rate was lower in these patients, lack of biliary distension was not associated with increased complications rates in the current study, whereas Pedersoli et al. reported increased risk of hemorrhage in this setting (1). One explanation for this result could be that in the present study, there was a significantly lower rate of cases with non-distended bile ducts (39.9% vs. 5.6%).
Non-distended biliary ducts, just like obesity, anasarca, and non-compliance, may be considered risk factors potentially affecting the outcome of PTBD (1,6,7,10,12,13); ascites is considered a relative contraindication (13). Previous data suggest that complication rates are elevated in such procedures (12). Neither accompanying risk factors nor the presence of ascites were associated with elevated complication rates in the present study. Complication rates were also not increased in emergency procedures or in procedures where dilatation of biliary stenosis was performed, while complication rates of ERCP are typically increased when dilatation/sphincterotomy is performed (27). Thus, when PTBD is required, the abovementioned risk factors should be seen only as relative contraindications.
Increased complication rates were observed in left-sided PTBD. As reported in previous studies, clinically relevant hemorrhage was also more frequent in left-sided PTBD in the current study (28,29). The anatomic arrangement of the Glisson triad has been postulated as a predisposing factor leading to more hemorrhagic complications in left-sided PTBD. In the anteroposterior direction, the bile duct is superimposed by the hepatic artery and the portal venous branch. The anatomic arrangement is less problematic for right-sided PTBD, as it is typically performed via a lateral approach.
Drainage-related complications were noted in 14.8% of procedures, which is lower than previously reported (23%) (17). Partial drainage catheter dislocation, drainage leakage, and occlusion were the most common problems. Dislocation was more frequent when drainages were not advanced into the duodenum/intestine. Apart from ensuring a more physiological drainage of bile, transpapillary advancement of drainage catheters apparently ensures more catheter stability. Thus, intestinal advancement of drainage catheters should be attempted when technically possible and cholangitis does not prohibit biliary manipulation.
Although complications were not increased in patients with malignant disease, drainage-related complications were observed more frequently in this collective. Multimorbidity, immunosuppression, or overall poor state of health may be influencing factors. As reported in previous studies (17), partial dislocation of the drainage was significantly more frequent in malignant underlying etiology than in benign etiology of disease.
Although this study was not conceptualized as a direct comparison between ERCP and PTBD, ERCP is the current clinical standard for biliary interventions. Therefore, it is the opinion of the authors that a comparison of the current data with previously reported results of ERCP is warranted; especially considering that >50% of the current patient collective had received ERCP before the attempt at PTBD.
Unlike ERCP, PTBD is no longer performed diagnostically. Thus, reported rates of technical success and complications typically only include procedures performed in diseased patients where treatment was required. ERCP studies typically also include diagnostic procedures. When comparing the current results with previous ERCP data, one has to bear in mind that the current data mainly include severely diseased patients, where (in the majority of procedures) prior ERCP had failed to alleviate symptoms. Nevertheless, the present results are comparable to previous ERCP data with low complication rates and a low 30-day mortality. The PTBD-associated mortality rate was 0.5% (n = 2), which is lower than in previous PTBD studies (6%) (17) and equal to ERCP (< 0.5%) (30).
In conclusion, the present results confirm that PTBD is a safe and effective method for the treatment of biliary obstruction and biliary leaks in both malignant and benign disease. In this study cohort, comprising mostly patients in whom prior ERCP had failed to alleviate symptoms, technical and therapeutic success rates were high, complication rates were low. Unlike previously assumed, obesity, the lack of biliary distension, non-compliance, and even the presence of ascites were not linked with increased complication rates.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
