Percutaneous insertion of a novel dedicated metal stent to treat malignant hilar biliary obstruction

Table 1 Patient’s baseline characteristics

Characteristics	Value
Total number of patients, n	18
Median age, yr	71
Range age, yr	37-84
Male sex, n (%)	11 (61.1)
Etiology, n (%)
Cholangiocarcinoma	12 (66.6)
Gallbladder carcinoma	5 (27.7)
Colorectal liver metastases	1 (5.5)
Chemotherapy	17 (94.4)

Table 2 Clinical outcomes

Endpoint	Value
Technical success, n (%)	18 (100)
Clinical success, n (%)	18 (100)
Periprocedural complications, n (%)	1 (5.5)
Stent-related complications, n (%)	5 (27.7)
Stent occlusion, n (%)	1 (5.5)
Stent migration, n (%)	1 (5.5)
Mean procedural duration min	81.5 ± 32.2
Median stent patency days (range)	169 (93-315)
Overall mortality, n (%)	4 (22.2)

Table 3 Patients with stent-related complications

Age/sex	Etiology	Clinical manifestations	US findings	PTC findings	Treatment
75/F	GC	Jaundice	Left intrahepatic biliary dilatation	Stent migration	Additional MCS using SIS technique
77/M	CC	Jaundice	Bilateral intrahepatic biliary dilatation	Stent occlusion	PTBD
68/F	CC	Cholangitis	Aerobilia and no biliary dilatation	Not performed	Antibiotic therapy
81/M	CC	Cholangitis	Aerobilia and no biliary dilatation	Not performed	Antibiotic therapy
75/F	CC	Cholangitis	Aerobilia and no biliary dilatation	Not performed	Antibiotic therapy

GC: Gallbladder carcinoma; CC: Cholangiocarcinoma; US: Ultrasound; PTC: Percutaneous transhepatic cholangiography; MCS: Moving Cell Stent; PTBD: Percutaneous transhepatic biliary drainage; SIS: Stent-in-stent.

Table 4 Laboratory tests

	PRE-PTBD	PRE-stent	POST-stent	P value
Total bilirubin (mg/dL)	15.2 ± 6.0	4.04 ± 1.50	1.31 ± 0.40	< di 0.001
Direct bilirubin (mg/dL)	13.5 ± 5.5	3.32 ± 1.30	0.86 ± 0.30	< di 0.001
ɣGT (U/L)	1389.2 ± 832.2	393.6 ± 321.7	114.6 ± 53.5	< di 0.001
Alkaline phosphatase (mU/mL)	321.7 ± 250.0	200.3 ± 179.4	115.7 ± 117.8	0.037
AST (UI/L)	243.9 ± 136.4	93.5 ± 47.6	50.6 ± 21.8	< di 0.001
ALT (UI/L)	319.3 ± 242.7	104.3 ± 53.3	71.7 ± 40.7	< di 0.001
WBC (10³/µL)	10.2 ± 3.1	9.82 ± 4.00	7.16 ± 1.70	< di 0.001
PCR (mg/dL)	3.1 ± 1.5	3.9 ± 6.5	1.2 ± 1.2	< di 0.002

PTBD: Percutaneous transhepatic biliary drainage; ALT: Alanine aminotransferase; WBC: White blood cell; PCR: Polymerase chain reaction.