Might Biliary Radiofrequency Ablation Be Less Effective Than We Thought?
Bret T. Petersen, MD, MASGE, reviewing Albers D, et al. Gastrointest Endosc 2022 Jun 3.
Most inoperable malignant biliary strictures are best treated with self-expanding metal stents (SEMS); however, a significant portion of patients develop stent occlusion from neoplastic or hyperplastic ingrowth of the stent. Intraductal treatment with radiofrequency ablation (RFA) just prior to stent placement or at the time of stent occlusion has been used to prolong stent patency and, perhaps, longevity. The supporting data for biliary RFA therapy at the time of SEMS placement are modest at present.
The authors performed a multicenter randomized controlled trial (RCT) of SEMS placement with preceding RFA therapy (RFA-SEMS) or without RFA (SEMS-only). All patients had nonresectable malignant biliary obstruction from pancreatic (n=54), biliary (n=21), or metastatic (n=11) sources, which were similarly distributed between treatment groups. Most strictures were extrahepatic, with only 12 patients with proximal or hilar lesions and only 10 receiving more than one stent.
Technical success was 100% for RFA delivery, using the Habib catheter (Boston Scientific, Marlborough, MA) at 10W for 90 seconds, and 98.8% for stent placement. The primary outcomes of stent patency at 3 and 6 months after stent placement were not significantly different (RFA-SEMS: 73.1% and 33.3% vs SEMS-only: 81.8% and 52.4%; P=.6), and survival was not altered by the addition of RFA. Subgroup analyses by location and tissue types were similarly equivalent. Early adverse events within 30 days were insignificantly higher in the RFA-SEMS group (n=4, including 1 severe [10.5%]) versus the stent-alone group (n=1, mild [2.3%]; P=.18).
COMMENTIn this multicenter RCT of biliary SEMS placement for malignant strictures of mixed types and locations, the addition of RFA treatment before stenting did not improve patient survival or duration of biliary SEMS patency at 3 and 6 months. RFA at the time of stenting has been of greatest interest for hilar lesions, which may occlude earlier and are far more challenging to palliate at subsequent procedures. The small number of patients with hilar strictures in this study does not allow inference about the benefit, or lack thereof, for these lesions. Newer temperature-controlled RFA devices are touted as less prone to excessive depth of injury with associated hilar fistulae and bleeding, but this remains uncertain. Further studies comparing devices in single tissue types and locations are warranted.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S)
Albers D, Schmidt A, Schiemer M, et al. Impact of endobiliary radiofrequency ablation on biliary drainage in patients with malignant biliary strictures treated with uncovered self-expandable metal stents: a randomized controlled multicenter-trial. Gastrointest Endosc 2022 Jun 3. (Epub ahead of print) (https://doi.org/10.1016/j.gie.2022.05.022)
