Effect of RFA in patients with malignant biliary obstruction

MEMBER ARTICLE

Jarosova J,Zarivnijova L, Ivana Cibulkova I, et al. Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomized trial. Gut. 2023 Aug 31:gutjnl-2023-329700.

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 Jarosova J,Zarivnijova L, Ivana Cibulkova I, et al. Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomized trial. Gut. 2023 Aug 31:gutjnl-2023-329700. 

Question/Hypothesis 

The endoluminal biliary RFA positively impacts overall survival and stent patency in patients with malignant biliary obstruction.

Design 

A randomized trial in three tertiary referral centers.

Patients

Patients with histologically confirmed malignant biliary obstruction caused by either cholangiocarcinoma (CCA) or pancreatic adenocarcinoma (PDAC). Patients with the two different tumor types were treated separately. The patients were split into an RFA group and a control group for each tumor type based on simple randomization. Follow-up lasted until death or termination of the study.

Interventions

Randomization in a 1:1 ratio in blocks of 10 patients stratified by tumor type. Central randomization using opaque and sealed envelopes, which were opened intraprocedurally. All patients underwent the procedure for which they were allocated. The endoscopist could not be blinded. Patients remained blinded.

Patients were randomized to either RFA+stent (RFA group) or stent only (control group).

Outcome

The primary outcome was patient survival. Secondary outcomes were stent patency 3, 6, 9, and 12 months after treatment, immediate and later (within 30 days) adverse events, and quality of life.

Data analysis

The sample size in each group was 70 (140 per tumor type, 280 total for the whole study), with a 0.05 level two-sided log-rank test for equality of survival curves and 80% power.

An interim analysis was planned after acquiring at least 50% of the planned data for each tumor type. The interim analysis resulted in study termination for futility.

Funding

A grant from the Czech Grant Research Council.

Results 

Patients were randomized to either RFA+stent (RFA group) or stent only (control group) (81 RFA+stent (44 CCA, 37 PDAC, 45 men, 36 women, mean age 72±9); 80 stent only (41 CCA, 39 PDAC, 45 men, 35 women, mean age 70±9)). In CCA, there were 73 cases (86%) of hilar cancer and 12 cases (14%) of distal cancer. No improvement in overall survival was observed in RFA-treated patients in either of the disease groups. In patients with CCA, the median survival time was 10.5 months (95% CI 6.7 to 18.3) for RFA vs 10.6 months (95% CI 9.0 to 24.8) for controls. In patients with PDAC, the median survival time was 6.4 months (95% CI 4.3 to 9.7) in the RFA group vs 7.7 months (95% CI 5.6 to 11.3) in the controls.

Patency rates and the need for reintervention were not influenced significantly by RFA treatment. No adverse events related to the procedure were reported.

COMMENTARY

Why Is This Important?

Contradictory information about the impact of RFA in patients with malignant biliary obstruction has been reported, including 2 meta-analyses.

Key Study Findings

RFA did not improve the survival of patients with inoperable CCA or PDAC. The study was terminated for futility as not even a trend favoring RFA was observed in an interim analysis.

 Caution

Most patients with CCA included in this trial were with hilar CCA. This is different from previous reports. Besides, the study did not reach the planned number of enrolled patients and was terminated after an interim analysis for futility. Patients were treated with a single session of RFA, so the impact of a different scheme involving two or multiple RFA sessions could be better.

My Practice

Regularly, I use RFA for patients with CCA, thinking about stent permeability and trying to improve the time patency and gain more free ERCP time for patients.  

For Future Research

There could be space for future RCT about the impact of RFA in patients with CCA but using different treatment protocols. Despite the technique's safety, caution should be exercised before implementing this strategy in routine clinical practice.

 

REFERENCES 

• de Jong DM, Fritzsche JA, Audhoe AS, et al. Comparison of Intraductal RFA plus stent versus stent-only treatment for unresectable perihilar cholangiocarcinoma-a systematic review and meta-analysis. Cancers (Basel) 2022;14:2079.
•  Sharaiha RZ, Natov N, Glockenberg KS, et al. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit Dig Dis Sci 2014;59:3099–102.
• 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;96:970–9.

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