The Ethics Committee of the First Affiliated Hospital of Zhengzhou University agreed to this retrospective study. From January 2016 to January 2021, 248 patients with BS underwent PTCB combined with biliary drainage at our department. Fifty-four cases were excluded because they did not meet the inclusion criteria, and 194 cases were included. The inclusion criteria for the study were as follows: 1) age range 18–80 years; 2) the direct bilirubin (DB) was significantly higher than the normal value by more than 3 times; 3) the clinical manifestations were typical BS, such as yellow staining of skin and mucosa, cholangitis and fever; 4) Eastern Cooperative Oncology Group (ECOG) score of 0–2; 5) complete clinical data and more than 6 months follow-up time span; 6) platelet count > 50×109/L and prothrombin time (PT) ≤ 25 s. The exclusion criteria were as follows: 1) uncontrollable ascites; 2) severe coagulation dysfunction; 3) ECOG score of 3–4; 4) severe cardiopulmonary dysfunction; and 5) incomplete data and follow-up time less than 6 months. All patients [male:female = 101:93, mean age (61.0 ± 9.3) years old] presented with clinical symptoms of BS, and preoperative enhanced CT/MR showed slight to severe intrahepatic bile duct dilatation. Preoperative total bilirubin (TB), direct bilirubin (DB) and alanine aminotransferase (ALT) were 169.4 ± 58.5 µmol/L (range: 93.6-342.1), 135.0 ± 50.4 µmol/L (range: 76.4-277.9), and 91.9 ± 40.6 U/L (range: 24.4-198.6), respectively. All procedures were performed by the three interventional radiologists at our center (Jiao D, Ren J and Han X, who had PTCB experience of 11, 15 and 25 years). The following information was recorded from the patient electronic records: age, sex, operator, PTCB approach (left or right approach), BS site, BS length, imaging findings (eccentricity, rat tail, truncation and filling defect sign), maximum lesion diameter at the BS area, and final pathological results.
Procedures
Blood routine, liver function, kidney function, electrolyte, coagulation function, electrocardiogram and tumor markers were examined before operation, and plain scan plus enhanced upper abdomen CT or MR were performed to understand the dilatation of bile duct, the location of BS, tumor size, and the planned puncture path.
The patient laid supine on the DSA (artis zeego, Siemens, Germany) examination bed, and a mixed solution of dizosin (10 mg) and dexmedetomidine hydrochloride (400 µg) was injected intravenously to obtain a sastifactory analgesic state. After routine disinfection and towel laying at the right costal area, local anesthesia was performed with 2% lidocaine (5 ml) at the skin puncture point, which was determined by preoperative enhanced CT/MR or introoperative US. A 21G Chiba needle (Cook, United States) was used to puncture the dilated bile duct, a platinum micro wire (0.018 inch×30 cm) was introduced to the biliary system after cholangiography (320 mg iodine/100 mL, Hengrui, Jiangsu, China, diluted 50% for use), a 6F dialator was introduced along the micro hydrophilic membrane wire, and another cholangiography was performed to confirm the BS length and extent. A 0.035-inch wire and 5F KMP catheter were exchanged with a 6F dialator, the BS part was opened with the cooperation of the guide wire and catheter, and the catheter finally entered the duodenum. Another 0.035 inch strength guide wire (145 cm in length, Radiofocus M, Terumo, Tokyo, Japan) was introduced to establish the skin-bile duct-duodenum approach. Along the guide wire, a 9F short sheath (23 cm long, cordis, USA) was introduced, whose end was located above the BS segment. After confirmation by angiography, the biopsy forceps (6.0 mm in diameter, Nanjing microport, China) were introduced to the BS part through a 9F sheath, the biopsy forceps were opened and pushed forward for 5–10 mm, and the biopsy forceps were then tightened to clamp the tissue. The biopsy forceps were withdrawn, and the tissue was fixed in 4% formaldehyde solution. PTCB was repeated 3–6 times until the sample size met the needs of clinical diagnosis (assessed by Shenglei Li pathologists, who had more than 15 years of experience). 8.5 F internal and external drainage tubes (Cook, USA) were introduced after biopsy, and the lateral drainage holes were allowed to cross the BS area. Liver protective and anti-infective drugs were given after the operation for 3–7 days.
Definition
Technical success was defined as successfully obtaining enough biliary tissue to complete the pathology examination. The final diagnosis was confirmed by surgery, other histology or cytology (i.e., percutaneous fine needle aspiration biopsy and bile cytology). If there was no histology or cytology, the patient was followed up for at least 6 months, and the patient was diagnosed as malignant if the size of the lesions was significantly increased and/or metastasis was found by imaging examination. If there was no obvious disease progression in clinical manifestations or imaging findings, it was diagnosed as benign. Diagnostic indicators included sensitivity, specificity, FNV and false-positive value (FPV). PTCB-related complications were defined according to the international Society of Interventional Radiology (SIR) operating guidelines[13]. In view of multifactorial analysis, malignant tumors are divided into two groups according to their origin: cholangiocarcinoma (malignant tumors originating from the bile duct epithelium) and noncholangiocarcinoma tumors (malignant tumors other than cholangiocarcinoma, such as pancreatic cancer, gallbladder cancer, hepatocellular carcinoma, duodenal cancer, and hilar metastatic lymph nodes).
Statistical analysis
Continuous data are expressed as the means ± standard deviation, and a t test was used to compare the indices of alanine aminotransferase, total bilirubin and direct bilirubin before and 1 week after drainage. Univariate and multivariate logistic regression analyses were used to identify independent prognostic factors associated with FNV. Statistical analysis was performed using SPSS software version 21.0 (IBM, Chicago, IL). A p value < 0.05 was considered to indicate a significant difference.