Interventional procedure overview of endoscopic bipolar radiofrequency ablation for malignant biliary obstruction
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Evidence summary
Population and studies description
This interventional procedure overview is based on 1,593 people from 5 RCTs (including a pilot RCT), 1 non-randomised comparative study and 1 systematic review and meta-analysis. Of these 1,593 people, 440 people had the RFA procedure after removing duplications. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 7 studies as the key evidence in table 2 and table 3, 1 Health Technology Assessment in the existing assessment, and lists other relevant studies in table 5.
Of the 6 primary studies, 3 studies were done in China, 2 in Korea and 1 in Germany. The follow-up duration ranged from 4 months to 32 months in 5 RCTs, and the longest duration was around 7 years in 1 observational study.
Primary RFA was done in 5 studies (Gao 2021; Albers 2022; Kang 2021a, 2021b; Yang 2018), and both primary and secondary RFAs were carried out in 1 study (Xia 2021). For the systematic review and meta-analysis (Cha 2021), 7 studies involved ERCP-directed RFA and 1 study (n=36) reported percutaneous RFA. Of the 7 studies, 6 studies were for primary RFA and only 1 study (Dutta 2017) reported both primary and secondary RFAs.
In terms of stent types, plastic stents were initially used in 3 RCTs (Gao 2021; Kang 2021b; Yang 2018), SEMS in 2 RCTs (Albers 2022; Kang 2021a), and both plastic and metal stents in 1 observational study (Xia 2021). It is worth noting that Kang (2021b) changed the plastic stents to uncovered SEMS at 3 months after the index procedure or in case of premature plastic stent malfunction. For the systematic review and meta-analysis (Cha 2021), plastic stents were used in 2 studies and SEMS in 6 studies.
Across all the studies, biliary strictures or obstructions were caused by cancer that was surgically unresectable or unsuitable for surgery. The most common cancer was CCA (mostly hilar and distal CCA), followed by pancreatic cancer, gallbladder cancer and others. In all but 1 primary study (Yang 2018), other anti-tumour treatments (such as chemotherapy) were allowed concomitantly or after the index procedure. Chemotherapy was identified as a key confounding factor for OS.
As part of this review, a meta-analysis was done, combining the results from the 6 primary studies which contained relevant and valid data using the same outcome measures. Data analysis and all pooled results including forest plots are available in the appendix.
Table 2 presents study details.
No. | First author, date country | Population characteristics | Study design | Inclusion criteria | Intervention | Follow up |
|---|---|---|---|---|---|---|
1 | Gao (2021) China (3 centres) | 174 (men, n=89; women, n=85)
| RCT (open-label; NCT01844245) | Age 18 years or over, obstructive jaundice caused by pathology-confirmed extrahepatic CCA or ampullary cancer which was unsuitable for surgery. |
| Median 31.8 months |
2 | Albers (2022) Germany (5 centres) | 86 (women, n=47; men, n=39; mean 71.6 years)
| RCT (DRKS00018993) | Age over 18 years, obstructive jaundice caused by unresectable malignancy, and malignant tumour causing consequential biliary stenosis with the need for biliary drainage. |
| 6 months |
3 | Kang (2021a) Korea (single centre) | 48 (male, n=30; female, n=18)
| RCT (open-label; NCT02646514) | Age over 19 years, malignancy that was surgically unresectable or medically unfit for surgery, MBS, and life expectancy more than 3 months. |
Percutaneous RFA was done in 4 people of each group. |
|
4 | Kang (2021b) South Korea (3 centres) | 30 (male, n=20; female, n=10)
| Pilot RCT (open- label; KCT0003275) | Age over 19 years, a confirmed MHBO because of CCA or gallbladder cancer which was unresectable or medically inoperable, life expectancy more than 3 months, and ECOG performance status 0 (fully active) to 1 (restricted in strenuous activity) |
For both groups, plastic stent was changed to uncovered SEMS after 3 months or in case of premature plastic stent malfunction. | 12 months
|
5 | Yang (2018) China (single centre) | 65 (male, n=33; female, n=32)
| RCT (NCT02592538) | Age 18 to 75 years, pathology-confirmed extrahepatic CCA, initial treatment, and KPS of 50 points or higher |
For both groups, stent replaced every 3 months or upon recurrent jaundice or cholangitis symptoms. | 21 months |
6 | Xia (2021) China (2 centres) | 883 (male, n=537; female, n=346; mean 65.3 years)
| Non-randomised comparative study (retrospective) | People with inoperable extrahepatic MBS who had ERCP therapies |
| 7 years |
7 | Cha (2021) | 420 (3 RCTs and 5 retrospective observational studies)
Age, not reported | Systematic review and meta-analysis | People with unresectable extrahepatic CCA or MBO; studies comparing treatment outcomes between endobiliary RFA with stent and stent only; RCTs and case-control studies with adjustment for confounding variables; and studies reporting the relative risks or odds ratios of survival rate and stent patency duration for both treatments. | ERCP-guided RFA in 7 studies and percutaneous RFA in 1 observational study (n=18); plastic stents used in 2 RCTs and SEMS in 1 RCT and 5 observational studies. | Not reported |
The risk of bias (RoB) was assessed using the Cochrane RoB Tool for RCTs, ROBINS-I (RoB in Nonrandomized Studies [NRSs] of Interventions) for NRSs, and ROBIS for systematic reviews. The RoB for RCTs was graded as "low" for low risk, "high" for high risk, and "some concerns". For NRSs, each domain of the RoB was rated as "low", "moderate", "serious", or "critical" for RoB. For systematic review, each domain of the RoB was judged as ''low,'' ''high,'' or ''some concerns.''. The overall RoB was determined according to the judgment for each domain. Among the RCTs, 3 studies (Gao 2021; Albers 2022; Yang 2018) were rated as low for all RoB domains, whereas for the other 2 studies (Kang 2021a, 2021b), concerns were raised for 1 domain (deviation from intended intervention as PTC was also allowed [4 people in Kang 2021a and 3 people in Kang 2021b] and no subgroup analysis of people with ERCP-guided RFA only) and they were rated as low for all other domains. So, the overall risk of bias was judged as low for 3 studies (Gao 2021; Albers 2022; Yang 2018) and some concerns for 2 studies (Kang 2021a, 2021b). For the retrospective, observational study (Xia 2021), it was rated as low for 4 domains (classification of intervention, deviation from intended intervention, missing data and measurement of outcomes) and as moderate for 3 domains (selection bias, (unmeasured) confounding, and reporting). So, the overall risk of bias was judged as moderate. In terms of the systematic review and meta-analysis (Cha 2021), based on ROBIS, there were some concerns regarding the synthesis (outcomes for ERCP-guided RFA not reported separately and no sensitivity or subgroup analysis), but the levels of concerns for all other domains were judged as low. | ||||||
Procedure technique
All 6 primary studies detailed the procedure technique and devices used. The most common catheter used was Habib EndoHPB, followed by ELRAcatheter. Four RFA generators were used.
This procedure was done under sedation or monitored anaesthesia. Biliary dilation could be done at the endoscopist's discretion. RFA was usually done with a power of 7 to 10 w for 90 sections with a subsequent cooling period of 60 seconds to reduce adverse events. The ablation was done in a stepwise manner, covering the stricture from the proximal to the distal edge. More than 1 ablation could be done in a single session. After RFA, plastic or metal stents were inserted. Repeated RFA sessions could be done (Gao 2021; Kang 2021b; Yang 2018; Xia 2021).
Efficacy
The meta-analysis of the 6 primary studies was done, and the pooled results of stent patency and OS can be found in the appendix.
Clinical success
Clinical success was reported in 4 studies, with its rate ranging from 88% to 100%. When comparing RFA plus stent with stent only, no statistically significant difference was found in general.
Gao (2021) did not find any statistically significant difference in clinical success for jaundice control between the RFA plus plastic stent group (n=87) and the plastic stent only group (n=87; 92% versus 91%, p>0.99). Similarly, Kang (2021a) reported that the clinical success rate did not have a statistically significant difference between the RFA plus SEMS group (n=24) and the SEMS only group (n=24; 88% versus 83%, p=1.000). Kang (2021b) also did not see any statistically significant difference in clinical success between the RFA plus plastic stent group (n=15) and the plastic stent only group (n=15; 100% versus 87%, p=0.483).
In a non-randomised comparative study of 883 people, Xia (2021) noted that the rate of clinical success was statistically significantly higher in the RFA plus stent group (n=124) than the stent only group (n=759; 93% versus 85%, p=0.024). But after PSM no statistically significant difference was found between groups (93% of 124 people versus 89% of 496 people, p=0.190).
Stent patency
Stent patency was described in 6 studies. There were conflicting results in the duration of stent patency or the patency rate between RFA plus stent and stent only. But no statistically significant difference was found, except for the Yang (2018) study.
Gao (2021) did not find any statistically significant difference in the cumulative stent patency duration after the second procedure between the RFA plus plastic stent group and the plastic stent group (3.7 months versus 4.1 months, p=0.674; HR, 1.069; 95% CI, 0.782 to 0.460).
Albers (2022) did not report any statistically significant difference in the patency rate between the RFA plus SEMS group (n=42) and the SEMS only group (n=44) after 3 months (73% versus 82%, p=1.0) and 6 months (33% versus 52%, p=0.6). The patency rate in the subgroup with extrahepatic strictures showed no statistically significant difference after 3 and 6 months between groups. So, the patency rate in the subgroup with pancreatic cancer (SEMS only, n=18; RFA plus SEMS, n=16) showed no statistically significant difference after 3 and 6 months.
Kang (2021a) also did not find any statistically significant differences in the median duration of stent patency (132 days versus 116 days, p=0.440) and the 90‑day stent patency rate (58% versus 46%, p=0.386) between the RFA plus SEMS group and the SEMS only group.
Kang (2021b) reported that ITT analysis of 30 people (15 in each group) did not show any statistically significant difference in the total event-free stent patency between the RFA plus plastic stent group and the plastic stent only group (178 days versus 122 days, p=0.154). But the authors found that in people with each stricture length of 11 mm or longer on both sides, stent patency was statistically significantly longer in the RFA plus plastic stent group than in the plastic stent only group (175 days versus 121 days, p=0.028). More people had elective exchange to SEMS without plastic stent occlusion in the RFA plus stent group than in the stent only group (69% versus 23%, p=0.018).
Yang (2018) reported that the duration of stent patency was statistically significantly longer in the RFA plus plastic stent group than the plastic stent only group (6.8 months versus 3.4 months, p=0.02), and stent length was comparable between groups.
In a systematic review and meta-analysis of 420 people who had RFA plus stent or stent only (3 RCTs and 5 retrospective observational studies; RFA plus stent, n=190; stent only, n=230), Cha (2021) described that no statistically significant difference was found in the duration of stent patency between groups (HR, 0.79; 95% CI 0.57 to 1.09, I2=7%; 2 RCTs and 2 observational studies).
OS
OS was reported in all 7 studies and the evidence suggested a trend in favour of RFA plus stent. A statistically significant level was achieved in 3 studies (Gao 2021; Yang 2018; Xia 2021) and in a systematic review and meta-analysis (Cha 2021).
Gao (2021) found that the median OS was statistically significantly higher in the RFA plus plastic stent group than the plastic stent only group (14.3 months versus 9.2 months; HR, 0.488; 95% CI, 0.351 to 0.678; p<0.001). A survival benefit was also shown in people with CCA (13.3 months versus 9.2 months; HR, 0.546; 95% CI, 0.386 to 0.771; p<0.001).
Kang (2021a) did not find any statistically significant difference in median OS between the RFA plus SEMS group and the SEMS only group (244 days versus 180 days, p=0.281).
Albers (2022) described that the overall mortality after 3 and 6 months did not differ statistically significantly in both groups (RFA plus SEMS, 24% and 42%, p=0.56; SEMS, 27% and 50%, p=0.99). Similar results were found in the cohort with extrahepatic strictures (37 people in each group) and in the pancreatic cancer subgroup (SEMS only, n=18; RFA plus SEMS, n=16). The addition of RFA did not impact OS (HR, 0.72; p=0.389 for RFA plus SEMS).
Yang (2018) reported that the mean OS time was statistically significantly longer in the RFA plus plastic stent group than the plastic stent only group (13.2 months versus 8.3 months, p<0.001). The survival rates were statistically higher in the RFA plus plastic stent group than the plastic stent only groups at 9 months (88% versus 24%), 12 months (63% versus 12%) and 15 months (28% versus 3%; all p<0.05) but not at 6 months (97% versus 82%, p=0.08). Multivariable Cox regression analysis showed that RFA was the main protective factor affecting the survival of people (HR 0.182, 95% CI, 0.08 to 0.322; p<0.001).
Kang (2021b) described that ITT analysis of 30 people did not show any statistically significant difference in OS between the RFA plus plastic stent group and the plastic stent only group (230 days versus 144 days, p=0.643).
Xia (2021) reported that the median OS was statistically significantly longer in the RFA plus stent group than the stent only group (9.5 months versus 5.5 months, p<0.001). After PSM, people who had RFA plus stent also showed statistically significantly longer OS than those who had stent alone (9.5 months versus 6.1 months, p<0.001). In multivariable Cox proportional hazard models, RFA plus stent was found to be an independent predictor of OS (HR, 0.552; 95% CI, 0.438 to 0.697; p<0.001), In stratified analyses, the improved OS was only showed in the subgroup of extrahepatic CCA (11.3 months versus 6.9 months, p<0.001) but not in the subgroups of other cancers (all p>0.05). The survival benefit was noted only in the people with non-metastatic CCA (11.5 months versus 7.4 months, p<0.001).
In the systematic review and meta-analysis by Cha (2021), when comparing RFA plus stent with stent only, the pooled HR for OS was 0.47 (95% CI, 0.34 to 0.64, I2=44%; 8 studies). No significant publication bias was noted in the funnel plot for overall survival (Egger's test p=0.2869).
Quality of life
Quality of life was measured using KPS in 2 RCTs, suggesting a better quality of life after RFA plus stent than stent only. Gao (2021) reported that the postprocedural KPS scores were statistically significantly higher in the RFA plus plastic stent group than the plastic stent only group until 9 months (all p<0.05). Similarly, Yang (2018) described that the postoperative KPS scores of people in the RFA plus plastic stent group were statistically significantly higher than those of the plastic stent only group after 1 month (86.1 versus 72.4), 3 months (71.4 versus 60.3), 6 months (61.4 versus 48.2), and 9 months (58.2 versus 22.5, all p<0.05). The authors of both RCTs described that the preoperative KPS scores were comparable between groups.
Safety
The pooled results of cholangitis and cholecystitis can be found in the appendix.
Overall postoperative adverse events
In general, the overall postoperative adverse events were comparable between people with RFA plus stent and people with stent only across studies.
Gao (2021) did not find a statistically significant difference in early (within 30 days; 28% versus 20%, p=0.211) or late adverse events (39% versus 37%, p>0.99) between the RFA plus plastic stent group and the plastic stent only group.
Albers (2022) did not report a statistically significant difference in adverse events between the RFA plus SEMS group and the SEMS only group within the first 30 days after the procedure (11% versus 2%, p=0.18).
Kang (2021a) described that the early complication (within 7 days) rates were not statistically significantly different between the RFA plus SEMS group and the SEMS only group (4% versus 13%, p=0.609), and there were no late complications (7 to 30 days) in both groups.
Yang (2018) did not find a statistically significant difference in the incidence of postoperative adverse events between the RFA plus plastic stent group and the plastic stent only group (6% versus 9%, p=0.67).
Xia (2021) found that the overall complication rates were comparable between the RFA plus stent group and the stent only group before and after PSM (unmatched: 19% versus 20%; matched: 19% versus 16%). The authors also found that the total post-ERCP complication rates were comparable between the RFA plus stent group and the stent only group before and after PSM (9% versus 5%).
In the systematic review and meta-analysis (Cha 2021), no study showed any statistically significant difference in adverse events between the RFA plus stent group and the stent only group.
Cholangitis
Cholangitis was described in all studies and its incidence was generally comparable between the RFA plus stent group and the stent only group.
Gao (2021) did not find a statistically significant difference in cholangitis (acute cholangitis: 11.5% versus 10.3%, p=0.808; delayed cholangitis, 38% versus 37%, p=0.875) between the RFA plus plastic stent group and the plastic stent only group within 30 days after the procedure. Kang (2021b) did not report any statistically significant difference in cholangitis between the RFA plus plastic stent group and the plastic stent only group within the first 30 days (20% [n=3] versus 33% [n=5]) and more than 30 days after the procedure (33% [n=5] versus 33% [n=5]).
Albers (2022) reported cholangitis in 1 person in the RFA plus SEMS group but 0 in the SEMS only group within the first 30 days after the procedure. Similarly, Kang (2021a) reported cholangitis in 1 person in the RFA plus SEMS group but 0 in the SEMS only group within 30 days after the procedure. This case resulting in septic shock and death was reported as an unlikely related severe adverse event.
Yang (2018) reported acute cholangitis in 2 people (6.3%) in the RFA plus plastic stent group and 1 (3%) in the plastic stent group only after the procedure.
Xia (2021) reported that the incidence of cholangitis was statistically significantly lower in the RFA plus stent group than the stent only group (6.5% [8/124] versus 14% [108/759], p=0.017) before PSM. But this statistically significant difference was not found after PSM (7% [8/124] versus 10% [51/496], p=0.194).
In the systematic review and meta-analysis, Cha (2021) reported cholangitis regardless of symptoms in 34 people after RFA plus stent insertion.
Cholecystitis
Cholecystitis was reported in 4 studies and in 1 systematic review and meta-analysis. Gao (2021) and Xia (2021) found a statistically significantly higher incidence of acute cholecystitis in the RFA plus stent group than the stent only group. This finding was not supported by Kang (2021b) and Albers (2022).
Gao (2021) reported that the number of people experiencing acute cholecystitis was statistically significantly higher in the RFA plus plastic stent group than the plastic stent only group (10% versus 0%, p=0.003) within 30 days after the procedure. Of the 9 people with acute cholecystitis, 7 had hilar CCA, 1 had ampullary cancer, and 1 had distal CCA coexisting with gallstones. Xia (2021) reported that the incidence of acute cholecystitis was statistically significantly higher in the RFA plus stent group than the stent only group (6 versus 1, p<0.001) before and after PSM.
But Kang (2021b) did not find any statistically significant difference in cholecystitis between the RFA plus plastic stent group and the plastic stent group within the first 30 days (7% [n=1] in each group) and more than 30 days (7% [n=1] versus 0%) after the procedure. Albers (2022) reported cholecystitis with gallbladder perforation in 1 person in the RFA plus SEMS group but not in the SEMS only group within the first 30 days after the procedure.
In the systematic review and meta-analysis, Cha (2021) reported cholecystitis in 8 people after RFA plus stent insertion.
Pancreatitis
Pancreatitis was seen in 2 studies and in 1 systematic review and meta-analysis.
Gao (2021) did not find a statistically significant difference in post-ERCP pancreatitis (mild; 5% versus 6%, p>0.99) between the RFA plus plastic stent group and the plastic stent only group within 30 days after the procedure. Albers (2022) reported pancreatitis in 1 person in the RFA plus SEMS group but 0 in the SEMS only group within the first 30 days after the procedure. Cha (2021) reported pancreatitis and hyperamylasaemia in 3 people.
Perforation
Perforation was reported in 2 studies, with 1 case in each study after RFA plus stent insertion.
Xia (2021) did not find a statistically significant difference in the incidence of perforation between the RFA plus stent group and the stent only group before and after PSM (1 versus 0). This case was a minor duodenal perforation induced by a plastic stent and was successfully closed using endoscopic clipping. Albers (2022) reported cholecystitis with gallbladder perforation in 1 person in the RFA plus SEMS group but 0 in the SEMS only group within the first 30 days after the procedure.
Liver abscess
Gao (2021) saw 1 person with liver abscess in the RFA plus plastic stent group but not in the plastic stent only group after 30 days following the procedure.
Bleeding
Bleeding was described in 3 studies and its incidence was comparable between the RFA plus stent group and the stent only group.
Gao (2021) did not find a statistically significant difference in bleeding (1% versus 3%, p=0.621) between the RFA plus plastic stent group and the plastic stent only group within 30 days after the procedure. Albers (2022) reported bleeding in 1 person in the RFA plus SEMS group and 1 in the SEMS only group within the first 30 days after the procedure. Xia (2021) reported that the incidence of bleeding was comparable between the RFA plus stent group and the stent only group before and after propensity score matching (2% versus 1%).
Pain
Pain was reported in 2 studies and 1 systematic review and meta-analysis.
Kang (2021a) did not find any statistically significant difference in postprocedural pain between the RFA plus SEMS group and the SEMS only group (median 6.0 in each group; for VAS 7 or more, 13% [n=3] versus 33% [n=8], p=0.086). Kang (2021b) reported the median score of abdominal pain (NRS) 3 (IQR 0 to 4) in the RFA plus plastic stent group and 0 (IQR 0 to 5) in the plastic stent only group within the first 30 days after the procedure. Cha (2021) reported abdominal pain in 3 people.
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).
In addition to the adverse events reported in the literature, they did not list anecdotal or theoretical adverse events.
Three professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
The key evidence includes 5 RCTs, 1 non-randomised comparative study and 1 systematic review and meta-analysis. All 6 primary studies were conducted outside the UK. Most studies had a follow up of 4 to 32 months, although the observational study reported the data for 7 years. A mixture of cancer types was included in most studies, but the most common tumour was CCA.
In addition to the RoB assessment detailed in table 2, samples were often not adequately powered for key efficacy outcome measures. Sample size calculation was done in 4 RCTs but for different efficacy outcomes. 2 RCTs (Albers 2022; Kang 2021a) were reasonably powered for stent patency while the other 2 RCTs (Gao 2021; Yang 2018) were reasonably power for OS. Kang (2021b) was a pilot RCT with a small sample size. Therefore, statistical power was generally not desirable for key efficacy outcome measures across studies.
Stent patency was one of the key efficacy outcomes. This outcome was least affected by tumour types, concomitant systemic antitumour therapies or comorbidities (Albers 2022). Although there were conflicting results, in general, the evidence did not show any statistically significant difference in the duration of stent patency or the patency rate between the RFA plus stent group and the stent only group. This indicates no benefit in stent patency after RFA regardless of stent types.
However, the mechanism of stent occlusion differs principally between plastic stents and SEMS. Albers (2022) stated that tumour ingrowth is the main reason for malfunction of SEMS, resulting in stent occlusion. The occlusion of plastic stents is mainly caused by bacterial biofilm formation, biliary sludge, and duodenobiliary reflux. Endoscopic RFA preceding stent insertion aims at reducing tissue overgrowth. Therefore, the effect of RFA on the patency of different stents needs to be explored further.
OS was another key efficacy outcome. Across all the included studies, the evidence suggested a survival benefit in favour of RFA plus stent. It is noted that RFA is more like a local therapy than a systemic therapy and OS could be affected by many factors, such as stent patency, systemic control in combining with antitumour therapies (especially chemotherapy), cancer types and stages, and repeated RFA sessions.
Other antitumour treatments (such as chemotherapy) were allowed concomitantly or after the index procedure in all but 1 primary study (Yang 2018). However, the proportion of people who actually had antitumour therapies, in particular chemotherapy, was generally low across studies but comparable between the RFA plus stent group and the stent only group within studies. So, the survival benefit may be more presentative of people who were forgoing systemic treatments.
In respect of cancer type, the most common type of cancer was CCA. A survival benefit was generally directed towards people with MBO, mainly caused by extrahepatic CCA (especially in those without metastasis). Extrahepatic CCA mostly grows along the bile duct wall within limited thickness, thus the endoscopic RFA can reduce the maximal tumour load differing disease's progression (Xia 2021). For MOB caused by other cancers (such as pancreatic cancer), the survival benefit was uncertain.
More than 1 RFA session was allowed in 4 studies, and of these, 3 studies reported a statistically significant survival benefit after RFA plus stent compared with stent only (Gao 2021; Yang 2018; Xia 2021). It is noted that 1 study (Kang 2021b) had only 2 of 13 people were clinically eligible for a second RFA session, indicating the difficulty to repeat RFA in MHBO, due to some clinical obstacles such as active cholangitis. Although the results were indicative, the survival benefit after repeated RFA procedures was shown.
In terms of safety outcomes, no statistically significant difference was found in the overall postoperative adverse events, cholangitis and bleeding between people with RFA plus stent and people with stent only across studies. Regarding cholecystitis, 2 studies (Gao 2021; Xia 2021) found that its incidence was statistically significantly higher in people with RFA plus stent than people with stent only, suggesting extra precaution would be necessary during ablation. The incidences of pancreatitis, perforation and liver abscess were generally low.
In conclusion, most evidence focused on primary RFA, with CCA (mainly hilar and distal CCA) being the most common tumour. The evidence suggested that endoscopic bipolar RFA confers a survival benefit to people with MBO (mainly caused by CCA, particularly in those without metastasis). However, the evidence failed to exhibit a benefit for stent patency which is the primary aim of the procedure. Although endoscopic RFA, in addition to stent insertion, could improve quality of life but this was measured using KPS, so no data on quality of life using a conventional tool. More well-designed studies are warranted to evaluate the effects of endoscopic bipolar RFA in MBO caused by different tumour entities, stages and locations, in different RFA application protocols and in secondary RFA. To date, no ongoing trials specifically for this procedure have been identified.
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