Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial
Abstract
BACKGROUND AND AIMS
To compare the efficacy and safety between endoscopic radiofrequency ablation (RFA) and stent placement alone in patients with unresectable extrahepatic biliary cancer (EBC).
METHODS
In this randomized controlled trial, patients with locally advanced or metastatic cholangiocarcinoma (CCA) or ampullary cancer (AC) who were unsuitable for surgery were recruited from 3 tertiary centers. Eligible patients were randomly assigned to the RFA plus plastic stent placement (RFA group) or the plastic stent placement alone group (stent placement alone group) in a 1:1 ratio. Both groups underwent 2 scheduled interventions with an interval of approximately 3 months. The primary outcome was overall survival (OS).
RESULTS
Altogether, 174 participants completed the 2 index endoscopic interventions. No significant differences in the baseline characteristics were noted between the 2 groups. The median OS was significantly higher in the RFA group (14.3 vs 9.2 months; HR, 0.488; 95% confidence interval [CI], 0.351 -0.678; P<0.001). The survival benefit was also shown in patients with CCA (13.3 vs 9.2 months; HR, 0.546; 95% CI, 0.386 - 0.771; P<0.001). However, no significant between-group differences were found in jaundice control or stent patency duration. The postprocedural Karnofsky performance scores were significantly higher in the RFA group until 9 months (all P<0.001). Adverse events were comparable between the 2 groups (27.6% vs 19.5%, P=0.211), except for acute…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 174 participants or records.
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