New method
Clinical endoscopy
Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction

https://doi.org/10.1016/j.gie.2010.09.031Get rights and content

Background

In unresectable malignant bile duct obstruction in a patient with a life expectancy longer than 3 months, the use of self-expandable metal stents (SEMSs) is the standard technique to ensure continued biliary drainage. As many as 50% of patients with SEMSs will present with stent occlusion within 6 months. Changes to stent design and composition and concomitant therapy have failed to improve stent patency; therefore, alternative techniques to safely prolong stent patency are required.

Objective

To demonstrate the safety of endobiliary bipolar radiofrequency ablation (RFA) in patients with malignant biliary obstruction and to report the 90-day biliary patency of this novel procedure.

Design

Open-label pilot study.

Setting

Single tertiary care unit.

Patients

A total of 22 patients with unresectable malignant bile duct obstruction.

Interventions

Bipolar RFA within the bile duct.

Main Outcome Measurements

Immediate and 30-day complications and 90-day stent patency.

Results

A total of 22 patients (16 pancreatic, 6 cholangiocarcinoma) were recruited between January 2009 and April 2010. Deployment of an RFA catheter was successful in 21 patients. SEMS placement was achieved in all cases of successful RFA catheter deployment. One patient failed to demonstrate successful biliary decompression after SEMS placement and died within 90 days. All other patients maintained stent patency at 30 days. One patient had asymptomatic biochemical pancreatitis, 2 patients required percutaneous gallbladder drainage, and 1 patient developed rigors. At 90-day follow-up, 1 additional patient had died with a patent stent, and 3 patients had occluded biliary stents.

Limitations

Cohort study.

Conclusions

Endobiliary RFA treatment appears to be safe. Randomized studies with prolonged follow-up are warranted.

Section snippets

Patients

Patients with unresectable pancreatic or bile duct cancer were recruited for this pilot study. Exclusion criteria were uncorrected coagulopathy, cardiac pacemaker, failure to insert guidewire across a biliary stricture, Karnofsky score less than 40%,24 and inability to give informed consent. Prospective data were collected detailing ERCP complications, patient survival, and stent patency as long as 90 days after the procedure. Serial liver function tests (imaging where indicated) determined the

Results

Twenty-two patients were recruited for the study between January 2009 and April 2010. Patient data are shown in Table 1.

In 1 patient, irretrievable proximal migration of a plastic stent resulted in no attempt to deploy the RFA catheter; a SEMS procedure was undertaken.

SEMS placement was achieved in all cases of endobiliary deployment. There were no technical difficulties placing the RFA catheter across the biliary stricture. Six study subjects had evidence of hepatic hilar or intrahepatic

Discussion

This phase 1 study of endobiliary RFA treatment of malignant biliary obstruction demonstrates immediate and 30-day safety and 90-day biliary patency.

Potential complications identified in the preclinical pig model were extension of the RFA burn into local structures and difficulty reintroducing catheters into the bile duct after RFA treatment.22, 23 Furthermore, hemorrhage and abscess formation at the site of RFA are recognized complications of hepatic RFA.20, 21 These complications were not

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    DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: Ms. Nicholls: stockholder and board member of EMcision Ltd UK; Dr. Habib: stockholder and board member of EMcision Ltd UK. The other authors disclosed no financial relationships relevant to this publication.

    If you would like to chat with an author of this article, you may contact Dr Westaby at [email protected].

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