Comparison of intraluminal radiofrequency ablation and stents vs. stents alone in the management of malignant biliary obstruction

Figures & data

Figure 1. Flow diagram of patient selection.

Table 1. Demographic and baseline clinical characteristics of patients in the two groups.

	RFA-stent group (n = 50)	Stent group (n = 39)	p Value
Sex			0.178
Male	36 (72%)	22 (56.4%)
Female	14 (28%)	17 (43.6%)
Age (years), median (IQR)	62 (55–69)	68 (60–76)	0.021
Aetiology			0.160
Cholangiocarcinoma	25 (50%)	14 (35.9%)
Non-cholangiocarcinoma	25 (50%)	25 (64.1%)
Pancreatic carcinoma	10	15
Gallbladder carcinoma	4	1
Hepatocellular carcinoma	6	1
Metastatic tumours	5	8
Level of biliary obstruction^a			0.503
Common bile or hepatic duct (type I)	11 (22%)	14 (36%)
Hepatic confluence
Type II	8 (16.0%)	6 (15%)
Type III A	10 (20%)	5 (13%)
Type III B	4 (8%)	1 (3%)
Intrahepatic (type IV)	17 (34%)	13 (33%)
Performance status score^b			0.480
0	10 (20%)	6 (15.4%)
1	22 (44%)	14 (35.9%)
2	18 (36%)	19 (48.7%)
Co-therapy for primary disease			0.196
None	33 (66%)	31 (79.5%)
Surgery	9 (18%)	7 (17.9%)
Chemotherapy	1 (2%)	1 (2.6%)
TACE or microwave ablation	2 (4%)	0
More than one criterion	5 (10%)	0
Previous cholangitis	22 (44%)	14 (35.9%)	0.516

Unless otherwise indicated, data are number of patients and data in parentheses are percentages. TACE: transcatheter arterial chemoembolisation.

^a According to the Bismuth classification of perihilar cholangiocarcinoma.

^b According to toxicity and response criteria of Eastern Cooperative Oncology Group (ECOG).

Table 2. Procedure details of patients in the two groups.

Characteristic	RFA-stent group (n = 50)	Stent group (n = 39)	p Value
Technical success rate (%)	49 (98%)	37 (94.9%)	0.579
Clinical success rate (%)	46 (92%)	33 (84.6%)	0.324
Length of initial stricture (cm)	61	43	0.835
2	1 (1.6%)	1 (2.3%)
2.1–2.9	1 (1.6%)	1 (2.3%)
3.0–3.9	9 (14.8%)	9 (20.9%)
4	50 (82.0%)	32 (74.4%)
No. of stents of initial procedures	50	39	0.142
1	39 (78%)	35
2	11 (22%)	4
Sizes of SEMS of initial procedures (diameter × length)	61	43
6mm × 4cm	1 (1.6%)	0
6mm × 6cm	1 (1.6%)	1 (2.3%)
6mm × 8cm	3 (4.9%)	1 (2.3%)
8mm × 4cm	8 (13.1%)	5 (11.6%)
8mm × 6cm	21 (34.4%)	13 (30.2%)
8mm × 8cm	5 (8.2%)	3 (7.0%)
10mm× 4cm	3 (4.9%)	2 (4.7%)
10mm × 6cm	11 (18%)	13 (30.2%)
10mm × 8cm	6 (9.8%)	5 (11.6%)

Table 3. Complications of procedures in the two groups.

	RFA-stent group (n = 50)	Stent group (n = 39)	p Value
Adverse events	67	36	0.159
Early complication	45	23	0.496
Minor complication	24	10	0.519
Pain	19 (38%)	8 (20.5%)	0.104
Mild bleeding	5 (10%)	1 (2.6%)	0.225
Major complication	22	13	0.882
Moderate bleeding	2 (4%)	1 (2.6%)
Cholangitis	10 (20%)	6 (15.4%)
Acute pancreatitis	1 (2%)	1 (2.6%)
Other	1 (2%) Arrhythmia	0
Late complication	21	19	0.167
Nonocclusion cholangitis	2 (4%)	0
Recurrent obstruction	19	19	0.371
Sludge	1 (2%)	5 (12.8%)
Tumour ingrowth	6 (12%)	3 (7.7%)
Tumour overgrowth	8 (16%)	6 (15.4%)
Stent migration	1 (2%)	2 (5.1%)
New stricture	3 (6.0%)	3 (7.7%)

Figure 2. Overall survival curves in patients with unresectable MBO who underwent RFA-stent and stent. Data were obtained with Kaplan–Meier method. (A) Whole study population (RFA-stent group: n = 50, median OS = 5.0 months; stent group: n = 39, median OS = 4.7 months; p = 0.068). (B) Patients in cholangiocarcinoma subgroup (RFA-stent group: n = 25, median OS = 6.7 months; stent group: n = 14, median OS = 4.5 months; p = 0.307). (C) Patients in non-cholangiocarcinoma subgroup (RFA-stent group: n = 25, median OS = 7.3 months; stent group: n = 25, median OS = 5.3 months; p = 0.137).

Figure 3. Graph shows PSP for patients with unresectable MBO who underwent RFA-stent and stent. Data were obtained with Kaplan–Meier method. (A) Whole study population (RFA-stent group: n = 50, median PSP = 7.0 months; stent group: n = 39, median PSP = 5.0 months; p = 0.006). (B) Patients in cholangiocarcinoma subgroup (RFA-stent group: n = 25, median PSP =7.6 months; stent group: n = 14, median PSP = 4.3 months; p = 0.009). (C) Patients in non-cholangiocarcinoma subgroup (RFA-stent group: n = 25, median PSP = 6.3 months; stent group: n = 25, median PSP = 5.2 months; p = 0.266).

Figure 4. Graph shows SSP for patients with unresectable MBO who underwent RFA-stent and stent. Data were obtained with Kaplan–Meier method. (A) Whole study population (RFA-stent group: n = 58, median SSP = 10.0 months; stent group: n = 39, median SSP = 5.6 months; p < 0.001). (B) Patients in cholangiocarcinoma subgroup (RFA-stent group: n = 25, median SSP =12.6 months; stent group: n = 14, median SSP = 5.0 months; p < 0.001). (C) Patients in non-cholangiocarcinoma subgroup (RFA-stent group: n = 25, median SSP = 10.3 months; stent group: n = 25, median SSP = 5.5 months; p = 0.013).