. 2021 Jan 15;54(1):100–106. doi: 10.5946/ce.2020.254

Table 1.

Summarized Study Designs, Outcomes and Adverse Events among the Eight Enrolled Studies

Study	Study design	No. of patients		Outcome	Median time (95% CI, mo)		HR (95% CI) for RFA	Adverse events
Study	Study design	RFA+S	Stent	Outcome	RFA+S	Stent	HR (95% CI) for RFA	Adverse events
Sharaiha et al. (2014) [12]	Retrospective	26	40	Overall survival	5.9 for both groups (not reported for each group)		0.29 (0.11–0.76)	Abdominal pain 3; Pancreatitis 1; Cholecystitis 1
Kallis et al. (2015) [13]	Retrospective	23	46	Overall survival	7.5	4.1	0.66 (0.410–1.063)	Hyperamylasemia 1; Cholangitis 1
Kallis et al. (2015) [13]	Retrospective	23	46	Stent patency	15.7	10.8	1.186 (0.536–2.656)	Hyperamylasemia 1; Cholangitis 1
Hu et al. (2016) [8]	RCT	32	31	Overall survival	10.4 (8.0–12.7)	57.3 (4.8–6.6)	0.48 (0.27–0.85)^a)	Bleeding 1; Cholangitis 20; Cholecystitis 7
Hu et al. (2016) [8]	RCT	32	31	Overall survival	5 (3.0–7.1)	3.9 (2.6–5.2)	0.90 (0.52–1.55)^a)	Bleeding 1; Cholangitis 20; Cholecystitis 7
Wang et al. (2016) [14]	Retrospective	18	18	Overall survival	6.1 (4.8–15.2)	5.8 (4.2–16.5)	0.598 (0.324–	Cholangitis 3
Wang et al. (2016) [14]	Retrospective	18	18	Stent patency	5.8 (2.8–11.5)	4.5 (2.4–8.0)	0.49 (0.25–0.93)^a)	Cholangitis 3
Dutta et al. (2017) [15]	Retrospective	15	16	Overall survival	7.3	4.9	0.39 (0.17–0.92)	Pancreatitis 1; Cholangitis 1
Yang et al. (2018) [7]	RCT	32	33	Overall survival	13.2±0.6^b)	8.2±0.5^b)	0.182 (0.08–0.322)	Cholangitis 2
Yang et al. (2018) [7]	RCT	32	33	Stent patency	6.8 (3.6–8.2)	3.4 (2.4–6.5)	N/A^c)	Cholangitis 2
Bokemeyer et al. (2019) [16]	Retrospective	20	22	Overall survival	11.4	7.4	0.54 (0.29–0.99)^a)	Cholangitis 6; panceratitis 2; Intestinal perforation 1^d)
Kang et al. (2021) [11]	RCT	24	24	Overall survival	8.3 (3.9–12.3)	6.0 (0.9–11.1)	0.71 (0.38–1.33)	Cholangitis 1
Kang et al. (2021) [11]	RCT	24	24	Stent patency	4.4 (3.3–5.5)	3.9 (1.1–5.9)	0.80 (0.45–1.42)	Cholangitis 1

CI, confidence interval; HR, hazard ratio; N/A, not available; RCT, randomized controlled study; RFA, radiofrequency ablation; RFA+S, radiofrequency ablation plus stent.

^a)

HR calculated from a log-rank p-value and number of event.

^b)

Mean survival time±standard error.

^c)

Information not available for estimation of HR.

^d)

One intestinal perforation with pneumothorax occurred in one study, however, authors commented that it was not related with RFA procedure, rather than by the scope device.