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    Implantation in Patients with Malignant Biliary Obstruction

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Image Credit: I J Radiol
outline
Abstract 1. Background 2. Objectives 3. Patients and Methods 4. Results 5.
Discussion References Copyright


THE RISK FACTORS OF EARLY BILIARY INFECTION AFTER 125I PARTICLES STENT
IMPLANTATION IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION

authors:

Fei Song 1 , Youquan Niu 2 , Xuelin Li 3 , Jiayin Che 1 , Hao Huang 3 , Yingying
Xiang 3 , * , Ming Huang 1 , **

1 Department of Minimally Invasive Intervention, The Third Affiliated Hospital
of Kunming Medical University, Kunming , China
2 Department of Radiology, The Second Affiliated Hospital of Kunming Medical
University, Yunnan, China
3 Department of Stomatology, Yan’an Hospital Affiliated to Kunming Medical
University, Kunming , China
Corresponding Authors:
* Corresponding Author: Department of Stomatology, Yan’an Hospital Affiliated to
Kunming Medical University, No.245 Renmin East Road, Panlong District, Kunming,
650031, China. Email: 25591394@qq.com
** Corresponding Author: Department of Minimally Invasive Intervention, The
Third Affiliated Hospital of Kunming Medical University, No.519 Kunzhou Road,
Xishan District, Kunming, 650118, China. Email: songfei19810717@163.com

--------------------------------------------------------------------------------

IJ Radiology: Vol.21, issue 2; e143789
published online: August 3, 2024
article type: Research Article
received: December 20, 2023
revised: May 17, 2024
accepted: May 20, 2024
DOI: https://doi.org/10.5812/iranjradiol-143789

how to cite: Song F, Niu Y, Li X, Che J, Huang H, et al. The Risk Factors of
Early Biliary Infection After 125I Particles Stent Implantation in Patients with
Malignant Biliary Obstruction. I J Radiol.
2024;21(2):e143789. https://doi.org/10.5812/iranjradiol-143789.


ABSTRACT

BACKGROUND:

Early biliary infection (EBI) is a significant and prevalent complication
following percutaneous transhepatic biliary stenting, especially in cases
involving the use of 125I particle stents for malignant biliary obstruction
(MBO).

OBJECTIVES:

This study aims to uncover potential risk factors contributing to EBI
post-implantation in this patient group.

PATIENTS AND METHODS:

In this retrospective study, a total of 231 patients who underwent 125I particle
stent implantation between January 2014 and December 2020 were included.
Screening based on inclusion/exclusion criteria identified a total of 178
patients (115 males and 63 females, aged 32 - 83 years). Early biliary infection
occurrence was monitored within the first 30 days following the stent
implantation, when infectious complications are most prevalent. We analyzed
baseline characteristics and perioperative parameters of patients, comparing
those who developed EBI with those who did not. Multivariate logistic regression
was employed to identify significant risk factors for EBI.

RESULTS:

Out of the 178 patients, 35 (19.7%) developed EBI within 30 days
post-implantation. Every EBI case was accompanied by a positive bile culture.
Notably, patients with EBI more frequently had diabetes [odds ratio (OR), 3.329;
95% confidence interval (CI), 1.129 - 9.819; regression coefficient (B) = 1.203;
P = 0.029], gallstones in the gallbladder or bile ducts (OR, 3.459; 95% CI,
1.060 - 11.283; B = 1.241; P = 0.040), higher level of biliary obstruction (OR,
3.008; 95% CI, 1.243 - 7.280; B = 1.101; P = 0.015), intraoperative biliary
bleeding (OR, 5.416; 95% CI, 1.569 - 18.696; B = 1.689; P = 0.008), and
postoperative intrahepatic pneumobilia (OR, 2.655; 95% CI, 1.108 - 6.362; B =
0.976; P = 0.029) compared to those without EBI. These factors were positively
correlated with EBI development post-implantation. Conversely, the duration from
percutaneous transhepatic biliary drainage (PTBD) to 125I stent implantation was
longer in patients without EBI (OR, 0.966; 95% CI, 0.940 - 0.992; B = - 0.035; P
= 0.012), suggesting a negative association with EBI occurrence.

CONCLUSION:

This study identifies diabetes, gallstones in the gallbladder or bile ducts,
high-level obstruction, intraoperative biliary bleeding, and postoperative
intrahepatic pneumobilia as significant risk factors for EBI. Additionally, a
longer interval from PTBD to 125I stent implantation emerges as a protective
factor against EBI in patients with MBO undergoing 125I particle stent
implantation. These risk factors can offer guidance to minimize post-125I
particle stent implantation biliary infection, thereby shortening
hospitalization for affected patients.

KEYWORDS

Early Biliary Infection Percutaneous Transhepatic Biliary Drainage Malignant
Biliary Obstruction 125I Particles Stent Implantation Risk Factor


1. BACKGROUND

Malignant biliary obstruction (MBO) is a pathological blockage caused by
malignancies in the bile duct, gallbladder, pancreas, ampulla of Vater, liver,
etc. (1). Cholestasis in the bile duct can lead to the penetration of bile into
the bloodstream. To avoid the adverse effects of hyperbilirubinemia, biliary
drainage is necessary (2). A meta-analysis based on 26 articles revealed that
preoperative biliary drainage improves the outcomes of malignant obstructive
jaundice after surgery (3). For patients unable to undergo surgery, percutaneous
transhepatic biliary drainage (PTBD) and endoscopic biliary drainage are
commonly used strategies (4).

Percutaneous transhepatic biliary stenting (PTBS) is a supplement to PTBD, which
can dredge the biliary tract, normalize plasma levels of bilirubin, and relieve
MBO-associated symptoms (5). In PTBS, metal stents are superior to plastic
stents due to longer patency and lower re-intervention rates (6). However, the
growth of tumor cells and mucosal hyperplasia significantly limit the cumulative
patency rate of metal stents, leading to the recurrence of biliary restenosis or
obstruction (7). Encouragingly, the development of 125I particle stents opens
new horizons. The implantation of 125I particle stents can not only dredge
obstruction but also inhibit the growth of tumor cells in the bile duct (8).
Pang et al. found that PTBS combined with 125I particles is more effective in
inhibiting biliary re-obstruction and prolonging survival time than PTBS alone
(9). Hasimu et al. also demonstrated that PTBS with 125I particles improves
stent patency and extends survival time in patients with MBO (10). With the
ability to prevent restenosis, 125I particle stent implantation shows great
potential in the treatment of MBO.

With the widespread application of PTBS, increasing attention has been paid to
complications. Early biliary infection (EBI) is a common early postoperative
complication after PTBS, manifesting as shivering, fever, and even septic shock,
posing a serious threat to patients' health and life (11). A previous study
reported that 125I particle stent implantation is superior to conventional
stents in reducing the risk of EBI, possibly due to the antimicrobial properties
of integrated 125I and variations in stent composition, design, or material
(12). Therefore, the prevention of EBI following 125I particle stent
implantation is urgently needed.

Controlling risk factors is an effective strategy for preventing potential
complications. Liu et al. revealed that diabetes, previous surgical or
endoscopic treatment, procedure time > 60 min, and intraprocedural biliary
hemorrhage are risk factors for EBI after PTBS (13). However, the risk factors
of EBI following 125I particle stent implantation are not fully revealed. In
this study, a total of 178 patients with MBO who underwent 125I particle stent
implantation were enrolled. The baseline characteristics and perioperative
parameters of these patients with or without EBI were retrospectively analyzed.


2. OBJECTIVES

This study aims to reveal potential risk factors of EBI after 125I particle
stent implantation, providing guidance for the clinical treatment of MBO.


3. PATIENTS AND METHODS

3.1. SUBJECTS

This study received approval from the Ethics Committee of our hospital (ethical
approval code: 2020-13). Informed consent was obtained from all cases.

As a retrospective study, a total of 231 patients who underwent 125I particle
stent implantation were collected from our hospital between January 2014 and
December 2020. All patients were diagnosed with MBO based on pathological and
imaging examinations. The inclusion criteria included: (1) > 18 years old; (2)
unable or unwilling to undergo surgical operation; (3) first-time stent
implantation. The exclusion criteria included: (1) benign biliary obstruction;
(2) presence of biliary infection before PTBD (n = 11); (3) history of PTBS and
biliary surgery (n = 6); (4) onset of severe organ dysfunction within 30 days
after implantation (n = 5); (5) postoperative infection in other sites (n = 3);
(6) missing clinical data and follow-up information (n = 28). Finally, a total
of 178 patients (115 males and 63 females, aged 32 - 83 years) were included and
analyzed in this study, comprising 35 patients with EBI and 143 patients without
EBI (Figure 1). Patients included in the study underwent routine preoperative
comprehensive assessments, including blood cell analysis, coagulation function
tests, electrocardiography, liver and kidney function assessments, electrolyte
analysis, abdominal computed tomography, magnetic resonance imaging, and
magnetic resonance cholangiopancreatography. The baseline data, including sex,
age, liver function [total bilirubin (TBIL), direct bilirubin (DBIL), aspartate
aminotransferase (AST), alanine aminotransferase (ALT), and albumin (ALB)],
blood routine [white blood cells (WBC), hemoglobin (HGB), and platelets (PLT)],
coagulation function [prothrombin time (PT) and activated partial thromboplastin
time (APTT)], comorbidity [diabetes mellitus (DM) and gallstones], obstruction
location, and tumor types were collected.

FLOW CHART DESCRIBING THE STUDY DESIGN (MBO, MALIGNANT BILIARY OBSTRUCTION;
PTBD, PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE; EBI, EARLY BILIARY INFECTION).

Figure 1.

Flow chart describing the study design (MBO, malignant biliary obstruction;
PTBD, percutaneous transhepatic biliary drainage; EBI, early biliary infection).

3.2. 125I PARTICLES STENT IMPLANTATION

The biliary 125I particle stent was purchased from Nanjing Micro-Tech Co., Ltd.
(Nanjing, China), with a diameter of 10 mm (Appendix 1). Before stent
implantation, PTBD was performed to determine the location and length of the
obstruction in the bile duct under the digital subtraction angiography suite
(Appendix 2). A guide wire was introduced through the PTBD tube, and the outer
sheath was replaced. Using a single-curved catheter alongside the guide wire,
the catheter traversed the narrowed bile duct segment. After removing the guide
wire, cholangiography through the catheter precisely located and determined the
length of the obstructed segment (Appendix 2). A 260 cm super-stiff, extra-long
guide wire was then exchanged before withdrawing the catheter (Appendix 2). The
number of 125I particles (diameter = 0. 8mm, length = 4.5 mm, effective
radiation radius = 17 mm, half-life = 59.43 days; Beike Biotechnology, Beijing,
China) was calculated by the radiotherapy treatment planning system (HGGR-2000;
Hokai Medical Instruments, Zhuhai, China) according to the tumor status. The
125I particles are disinfected using 75% alcohol or
high-temperature/high-pressure methods. They are then secured onto the particle
stent delivery device using forceps. While loading 125I particles, avoid
withdrawing the central metal support rod of the delivery device assembly. The
biliary 125I particle stent is guided to the lesion site along a super-stiff
guidewire and released upon confirming precise positioning using the proximal
method (Appendix 2). After withdrawing the 125I particle stent delivery system,
a standard biliary stent is advanced along the super-stiff guidewire to the site
of bile duct obstruction (Appendix 2). The regular biliary stent is positioned
to overlap with the radioactive particle stent, ensuring approximately a 10 mm
extension beyond the lesion's upper and lower margins. Contrast imaging is then
performed to confirm the release position and deployment status of the stent.
Finally, the PTBD external drainage catheter (Cook Medical, USA) is to be
retained in place and secured with appropriate dressing (Appendix 2).

Both PTBD and 125I particle stent implantation were performed by professional
senior physicians. After the implantation for 2 - 3 weeks, unobstructed bile
drainage was identified by cholangiography. Within 30 days after implantation,
EBI was identified by the characteristics of fever (≥ 37.3ºC), persistent
increase in white blood cells and neutrophils, positive bile culture, pain
around the liver region, and/or continuous progression of jaundice. EBI within
the initial 30 days post-stent implantation is consistent with clinical norms,
emphasizing the critical early period when infectious complications are most
prevalent.

For patients who develop EBI after 125I particle stent placement, if the PTBD
drainage tube is not removed, biliary drainage can be performed through the PTBD
drainage tube to control EBI. In cases of EBI, early administration of
antibiotics is recommended. In our hospital, broad-spectrum antibiotics such as
cefmetazole, cefoperazone-sulbactam, cefotiam, and piperacillin-tazobactam are
used based on clinical experience until the results of drug sensitivity tests
are available. Following the availability of sensitivity results, antibiotic
therapy is adjusted accordingly. In cases where infection control is inadequate,
and there is a tendency for worsening EBI, potent antibiotics like meropenem are
employed. In this study, among 35 patients with EBI, appropriate
anti-inflammatory treatment effectively controlled biliary infections.

3.3. STATISTICAL ANALYSIS

Statistical analysis was performed using SPSS 25.0 (IBM Corp. Released 2017. IBM
SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Continuous
data underwent normality assessment, and for normally distributed metric data,
the independent t-test was applied, with results presented as mean ± standard
deviation. Categorical data were presented as number (percentage), and those
between two groups were compared by χ2 test. This study classifies risk factors
associated with EBI into two categories: Patient-related and surgical-related
factors. Patient-related factors encompass sex, age, gallstones in the
gallbladder or bile ducts, types of malignant tumor, obstruction location (low-
or high-level), comorbidities (such as diabetes), preoperative liver function,
blood routine, PT, APTT, and postoperative intrahepatic pneumobilia. Surgical
factors include 125I particle numbers, intraoperative biliary bleeding, PTBD,
time from PTBD to 125I stent implantation (days), time from jaundice to 125I
stent implantation (days), and drainage tube removal. Observations are
independent of each other. Univariate and multivariable logistic regression
analyses were employed to identify independent risk factors influencing
postoperative EBI, with those having P < 0.05 subsequently subjected to
multivariate logistic regression analysis to identify independent risk factors
for EBI after 125I particle stent placement. P-values less than 0.05 were
considered statistically significant.


4. RESULTS

4.1. DISTRIBUTION OF BACTERIAL SPECIES IN EARLY BILIARY INFECTION

Within 30 days after implantation, EBI was observed in 35 patients (19.7%). The
bacterial species in these patients were identified by bile culture, with
positive results in all 35 cases. Escherichia coli (N = 17) was the dominant
gram-negative bacterium in bile samples, followed by Klebsiella pneumoniae (N =
5), Pseudomonas putida (N = 3), and Pseudomonas aeruginosa (N = 1).
Gram-positive bacteria included Enterococcus faecalis (N = 4) and Staphylococcus
(N = 1). Additionally, mixed bacterial infections and Candida were identified in
3 and 1 cases, respectively.

4.2. COMPARISONS OF BASELINE CHARACTERISTICS IN PATIENTS WITH AND WITHOUT EARLY
BILIARY INFECTION

The baseline characteristics of patients with and without EBI were compared. As
listed in Table 1, there were no significant differences in sex, age, liver
function (TBIL, DBIL, AST, ALT, and ALB), blood routine (WBC, HGB, and PLT),
coagulation function (PT and APTT), and tumor types between the non-EBI and EBI
groups. Notably, diabetes and gallstones (in the gallbladder or bile ducts) were
more frequent in EBI cases compared to non-EBI cases (P < 0.01). Patients with
high-level obstruction were also more likely to suffer from EBI (P = 0.013).

Table 1.

BASELINE CHARACTERISTICS OF PATIENTS WITH AND WITHOUT EARLY BILIARY INFECTION

ParametersNon-EBI (n = 143)EBI (n = 35)P-valueSex0.809Male93 (65.0)22
(62.9)Female50 (35.0)13 (37.1)Age (y)60.87 ± 10.7561.51 ± 9.920.749Liver
functionTBIL (μmol/L)342.82 ± 151.80328.94 ± 140.950.624DBIL (μmol/L)274.36 ±
106.43274.78 ± 116.250.984AST (IU/L)126.28 ± 118.43172.20 ± 170.000.063ALT
(IU/L)158.07 ± 148.84178.86 ± 174.920.476ALB (g/L)37.03 ± 4.9636.06 ±
6.560.330Blood routineWBC (× 109/L)7.14 ± 1.867.26 ± 2.180.744HGB (g/L)127.28 ±
16.73123.17 ± 17.190.197PLT (× 109/L)297.92 ± 97.87298.60 ±
84.330.970Coagulation functionPT (s)12.82 ± 1.5613.12 ± 1.370.290APTT (s)36.83 ±
4.5937.13 ± 3.810.726ComorbidityDiabetes12 (8.4)10 (28.6)< 0.001 aGallstones in
the gallbladder or bile ducts9 (6.3)8 (22.9)0.003 aObstruction location0.013
aHigh-level obstruction35 (24.5)16 (45.7)Low-level obstruction108 (75.5)19
(54.3)Types of malignant tumor0.998Bile duct74 (51.7)18 (51.4)Pancreas34 (23.8)9
(25.8)Secondary 16 (11.2)4 (11.4)Gallbladder9 (6.3)2 (5.7)Others 10 (7.0)2 (5.7)

Abbreviations: EBI, early biliary infection; TBIL, total bilirubin; DBIL, direct
bilirubin; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALB,
albumin; WBC, white blood cell; HGB, hemoglobin; PLT, platelet; PT, prothrombin
time; APTT, activated partial thromboplastin time.

a Significantly different at P < 0.05.

4.3. COMPARISONS OF PERIOPERATIVE PARAMETERS IN PATIENTS WITH AND WITHOUT EARLY
BILIARY INFECTION

The perioperative parameters were subsequently compared. The time from PTBD to
125I stent implantation was significantly longer in non-EBI cases than in EBI
cases (P = 0.009). However, the time from jaundice to 125I stent implantation
and the number of particles were not significantly different between cases with
and without EBI. Additionally, the removal of the drainage tube was not
associated with the onset of EBI. Notably, intraoperative biliary bleeding and
postoperative intrahepatic pneumobilia were more likely to be found in EBI cases
compared to non-EBI cases (P < 0.01) (Table 2).

Table 2.

PERIOPERATIVE PARAMETERS IN PATIENTS WITH AND WITHOUT EARLY BILIARY INFECTION A

ParametersNon-EBI (n = 143)EBI (n = 35)P-valueTime from jaundice to  125I sent
implantation (days)50.73 ± 31.0345.49 ± 17.640.339Time from PTBD to  125I sent
implantation (days)22.55 ± 25.1314.80 ± 16.890.009 bParticle numbers15.15 ±
4.6215.26 ± 5.020.907Intraoperative biliary bleeding9 (6.3)8 (22.9)0.003
bDrainage tube removal97 (67.8)22 (62.9)0.575Postoperative intrahepatic
pneumobilia53 (37.1)22 (62.9)0.006 b

Abbreviations: EBI, early biliary infection; PTBD, percutaneous transhepatic
biliary drainage.

a Values are expressed as mean ± SD or No. (%).

b Significantly different at P < 0.05.

4.4. IDENTIFICATION OF RISK FACTORS FOR EARLY BILIARY INFECTION

Based on the parameters with significant differences, multivariate logistic
regression analysis was performed to determine the potential risk factors for
EBI. As shown in Table 3, diabetes, gallstones in the gallbladder or bile ducts,
high-level obstruction, intraoperative biliary bleeding, and postoperative
intrahepatic pneumobilia were all identified as risk factors for EBI in patients
who underwent 125I particle stent implantation (P < 0.05). Conversely, the time
from PTBD to 125I stent implantation was identified as a protective factor
against EBI (P = 0.012).

Table 3.

MULTIVARIATE LOGISTIC REGRESSION ANALYSIS OF POTENTIAL RISK FACTORS FOR EARLY
BILIARY INFECTION AFTER I PARTICLE STENT IMPLANTATION

ParametersB-valueP-value aOR95% CIDiabetes1.2030.0293.3291.129 - 9.819Gallstones
in the gallbladder or bile ducts1.2410.0403.4591.060 - 11.283High
obstruction1.1010.0153.0081.243 - 7.280Intraoperative biliary
bleeding1.6890.0085.4161.569 - 18.696Postoperative intrahepatic
pneumobilia0.9760.0292.6551.108 - 6.362Time from PTBD to  125I sent
implantation-0.0350.0120.9660.940 - 0.992

Abbreviations: B, regression coefficient; OR, odds ratio; CI, confidence
interval; PTBD, percutaneous transhepatic biliary drainage.

a Significantly different at P < 0.05.


5. DISCUSSION

Malignant biliary obstruction is an ominous disorder of biliary obstruction and
cholestasis caused by the invasion of malignant tumors (14). Malignant biliary
obstruction is accompanied by high mortality mainly due to tumor progression,
liver failure, and sepsis (15). Percutaneous transhepatic biliary stenting,
characterized by minimal invasion and high efficiency, is a common therapeutic
strategy for MBO. The development of 125I particle stents brings great
advantages in prolonging biliary patency and survival time (13). However, the
onset of complications, including EBI, seriously affects the quality of life. In
this study, EBI was observed in 35 patients (19.7%) after 125I stent
implantation. Bile culture determined that the pathogens of EBI were mainly
gut-derived bacteria, such as E.coli, K.pneumoniae, and E.faecalis.
Additionally, several risk factors for EBI were identified, including diabetes,
gallstones in the gallbladder or bile ducts, high-level obstruction, short time
from PTBD to 125I stent implantation, intraoperative biliary bleeding, and
postoperative intrahepatic pneumobilia.

Diabetes is a common metabolic disease characterized by hyperglycemia (16). Many
previous studies have identified diabetes as a risk factor for EBI after PTBS
(11, 13). In this study, diabetes was more frequent in the EBI group than in the
non-EBI group and was subsequently determined to be a risk factor for EBI after
125I particle stent implantation. Our findings are consistent with previous
studies, illustrating that diabetes is a risk for the onset of EBI following
125I particle stent implantation. The possible mechanisms include: (1) the
reduction of insulin with anti-inflammatory effects (17); (2) weakened immune
defense, leading to microbial invasion and infection (18); (3)
diabetes-associated vascular disorders affecting blood flow around the bile
duct, benefiting the growth of anaerobic bacteria under a hypoxic environment
(19); and (4) hyperglycemia benefiting the growth of many bacteria in the bile
duct (20). Therefore, preoperative control of blood glucose is urgently needed
for patients requiring 125I particle stent implantation.

Gallstones grow inside the gallbladder or biliary tract, causing intermittent
obstruction of the cystic duct (21). Gallstones can lead to a series of
disorders, such as pain, jaundice, infection, and acute pancreatitis (22). A
previous study reported that gallstones are a risk factor for cholecystitis
within 30 days after PTBS (23). In this study, gallstones in the gallbladder or
bile ducts were determined to be a risk factor for EBI after 125I particle stent
implantation. This result demonstrates the adverse role of gallstones in the
outcomes of 125I stent implantation. The underlying mechanisms may be that
gallstones can block the stent with the contraction of the gallbladder and the
flow of bile, and the obstruction-induced cholestasis benefits bacterial growth,
contributing to EBI. To avoid the adverse effects of gallstones, premature
removal of PTBD drainage tubes is not recommended after stent implantation. When
gallstones block the stent, they can be removed through the drainage tubes.

The location of obstruction is closely associated with the risk of biliary
infection after drainage. Zhou et al. reported that the location of obstruction
is a risk factor for EBI following PTBS (24). Consistent with previous studies,
this study also revealed that high-level obstruction is a risk factor for EBI
after 125I particle stent implantation. High-level biliary obstruction is
characterized by an insidious onset and special anatomical location, which may
lead to an increased risk of stent implantation and predispose to a variety of
complications, such as EBI (25). For patients with high-level obstruction,
accurate location of the obstruction based on preoperative cholangiography is
necessary, and an appropriate stent should be customized to achieve sufficient
drainage and reduce the risk of EBI.

Intraoperative biliary bleeding may occur due to mechanical damage caused by
punctures, wire guides, and stents (26). Biliary bleeding can increase the risk
of biliary infection by bringing contaminated bile into the bloodstream. Liu et
al. reported that intraoperative biliary bleeding is an independent risk factor
for EBI after PTBS (13). Consistently, this study also revealed that
intraoperative biliary bleeding is a risk factor for EBI after 125I particle
stent implantation. Therefore, avoiding vascular damage during interventional
therapy is particularly important for reducing the risk of EBI.

Under normal circumstances, no gas is present in the bile duct. In this study,
postoperative intrahepatic pneumobilia was observed in 75 cases after 125I
particle stent implantation, which was more frequent in the EBI group than in
the non-EBI group. The subsequent analysis determined a positive correlation
between postoperative intrahepatic pneumobilia and EBI. The respiration of some
bacteria contributing to EBI may lead to the onset of intrahepatic pneumobilia.
After identifying bacterial gas in patients with postoperative intrahepatic
pneumobilia, the drainage tube should be temporarily retained for flushing bile
ducts.

The time from PTBD to 125I implantation was further determined to be a
protective factor for EBI. Patients with MBO usually have impaired immune
function (27). Hyperbilirubinemia can further weaken cellular defense responses
by stimulating cytotoxic reactions (28). Given that the normal protective
barrier of the bile duct is easily damaged, interventional therapies, including
PTBD, have a high risk of inducing biliary infection. Therefore, it is better to
wait for the improvement of bilirubin, liver and coagulation function, and
remission of edema in the bile duct wall before 125I particle stent
implantation. Our findings indicate that an appropriate extension of the time
from PTBD to 125I stent implantation is beneficial to reducing the risk of EBI.

In conclusion, patients with MBO have a relatively high incidence of EBI (19.7%)
after 125I particle stent implantation. Diabetes, gallstones in the gallbladder
or bile ducts, high-level obstruction, intraoperative biliary bleeding, and
postoperative intrahepatic pneumobilia are risk factors for EBI. The time from
PTBD to 125I stent implantation is a protective factor for EBI. However, this
study is based on data from a single center with a limited sample size,
potentially leading to biased results. The risk factors of EBI are not only
limited to those elucidated in this study. Further research with a larger sample
size and consideration of additional factors, such as the time of onset of
malignancy, patient weight loss and malnutrition, and immunosuppression, is
warranted.


FOOTNOTES

 * Authors' Contributions: F.S.: conceptualization, writing-original draft,
   funding acquisition and formal analysis; Y.N.: conceptualization,
   writing-original draft, and formal analysis; X.L.: investigation, validation,
   data curation; J.C.: validation, data curation, resources; H.H.:
   investigation, validation, data curation; Y.X.: conceptualization and
   writing-review &amp;amp;amp; editing; M.H.: conceptualization and
   writing-review &amp;amp;amp; editing; F.S. and Y.N. are co-first Author,
   these authors contributed equally to this work. All authors have read and
   approved the final manuscript.
 * Conflict of Interests Statement: The authors declare no conflict of interest.
 * Data Availability: The dataset presented in the study is available on request
   from the corresponding author during submission or after publication.
 * Ethical Approval: This study has received approval from the ethics committee
   of our hospital (ethical approval code, 2020-13) in accordance.
 * Funding/Support: This study was supported in part by the Scientific Research
   Fund of Yunnan Education Department (project number 2023Y0651), and the
   Yunnan Fundamental Research Projects (project number 202201AT070954).
 * Informed Consent: Verbal Informed consent was obtained from all participants.


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search relations: Author(s):
 * Fei Song: [PubMed] [Scholar]
 * Youquan Niu: [PubMed] [Scholar]
 * Xuelin Li: [PubMed] [Scholar]
 * Jiayin Che: [PubMed] [Scholar]
 * Hao Huang: [PubMed] [Scholar]
 * Yingying Xiang: [PubMed] [Scholar]
 * Ming Huang: [PubMed] [Scholar]

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