Safety and Efficacy of Radiofrequency Ablation in the Management of Unresectable Bile Duct and Pancreatic Cancer: A Novel Palliation Technique

Hindawi Publishing Corporation Journal of Oncology Volume 2013, Article ID 910897, 5 pages http://dx.doi.org/10.1155/2013/910897 Clinical Study Safety and Efficacy of Radiofrequency Ablation in the Management of Unresectable Bile Duct and Pancreatic Cancer: A Novel Palliation Technique Paola Figueroa-Barojas, Mihir R. Bakhru, Nagy A. Habib, Kristi Ellen, Jennifer Millman, Armeen Jamal-Kabani, Monica Gaidhane, and Michel Kahaleh Division of Gastroenterology and Hepatology, Department of Medicine, Weill Cornell Medical College, New York, NY 10021, USA Correspondence should be addressed to Michel Kahaleh; Received 25 January 2013; Accepted 4 March 2013 Academic Editor: Jose G. de la Mora-Levy Copyright © 2013 Paola Figueroa-Barojas et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objectives. Radiofrequency ablation (RFA) has replaced photodynamic therapy for premalignant and malignant lesions of the esophagus. However, there is limited experience in the bile duct. The objective of this pilot study was to assess the safety and efficacy of RFA in malignant biliary strictures. Methods: Twenty patients with unresectable malignant biliary strictures underwent RFA with stenting between June 2010 and July 2012. Diameters of the stricture before and after RFA, immediate and 30 day complications and stent patency were recorded prospectively. Results. A total of 25 strictures were treated. Mean stricture length treated was 15.2 mm (SD = 8.7 mm, Range = 3.5–33 mm). Mean stricture diameter before RFA was 1.7 mm (SD = 0.9 mm, Range = 0.5–3.4 mm) while the mean diameter after RFA was 5.2 mm (SD = 2 mm, Range = 2.6–9 mm). There was a significant increase of 3.5 mm (t = 10.8, DF = 24, P value = <.0001) in the bile duct diameter post RFA. Five patients presented with pain after the procedure, but only one developed mild post-ERCP pancreatitis and cholecystitis. Conclusions: Radiofrequency ablation can be a safe palliation option for unresectable malignant biliary strictures. A multicenter randomized controlled trial is required to confirm the long term benefits of RFA and stenting compared to stenting alone. 1. Introduction Self-expanding metal stents (SEMS) have become the mainstay palliative treatment for malignant biliary obstruction in patients with a life expectancy greater than 3 months [1, 2]. Their use has improved bile duct patency beyond what was achieved with plastic stents; however, long-term patency continues to be an unresolved issue. SEMS can occlude from tissue ingrowth or overgrowth, benign epithelial hyperplasia or secondary to biofilm, and sludge formation within the lumen of the stent [3]. Up to 50% of patients will have stent occlusion in the first 6 to 8 months [4, 5]. Different design alternatives have been explored in an attempt to improve stent patency. Covered SEMS were designed to prevent tissue ingrowth; however, they are contra-indicated for hilar drainage, have higher migration rates, and might be associated with increased risks of pancreatitis and cholecystitis [6–11]. Another treatment strategy to prolong stent patency and eventual survival is photodynamic therapy (PDT). PDT showed promising results; however, it carries a high complication rate including cholangitis and photosensitivity requiring the patient to avoid direct exposure to light for 4–6 weeks [12–14]. Radiofrequency ablation (RFA) has been used for tumor ablation in the esophagus [15], rectum [16], and liver [17]. It utilizes heat to achieve contact coagulative necrosis of surrounding tissue. Within the bile duct it seems to lead to improved stent patency by decreasing tumor ingrowth and benign epithelial hyperplasia [18]. This technique has been widely used to treat primary and secondary liver cancer [17]; however, the experience in malignant biliary obstruction is limited. There have been animal studies to assess the power 2 Journal of Oncology and duration of treatment [19], but there is only one study assessing this procedure in humans [20]. We aimed to assess the safety and efficacy of this novel palliative technique prospectively. 2. Methods Data on twenty patients were collected between June 2010 and July 2012. Inclusion criteria included patients with unresectable malignant biliary strictures, unresectable cholangiocarcinoma, or pancreatic cancer with biliary obstruction and a life expectancy greater than 3 months. Exclusion criteria included cardiac pacemaker, instability for endoscopy, uncorrected coagulopathy, and pregnancy. Patients were evaluated with comprehensive laboratory studies as well as crosssectional imaging prior to RFA and 30-days post RFA. All patients underwent RFA with either plastic or metal stent placement. Our primary outcome measures were the safety and efficacy of RFA. For efficacy measures, diameters of the stricture before and after RFA were recorded, as well as data on stent patency after a month was collected. Immediate and 30-day complications and stent patency were also recorded. Our study’s primary endpoints were success rate—efficacy of RFA in terms of biliary stricture dilation and safety profile with respect to frequency and intensity of adverse events. The study was approved by the institutional ethics review committee (http://www.clinicaltrials.gov/ identifier NCT01303159). 2.1. Technique of RFA. All procedures were performed under general anesthesia. Side viewing endoscopes TJF-160 and TJVF-160 (Olympus America, Center Valley, PA) were used for all procedures. All patients underwent biliary sphincterotomy. A cholangiogram was then performed to define stricture length and diameter (Figure 1). The Habib EndoHPB wire guided catheter (EMcision, Hitchin Herts, UK) was advanced over a wire at the level of the biliary stricture and ablation using a RITA 1500X RF generator (Angiodynamics, Latham, NY) set at 7–10 watts for a time period of 2 minutes was conducted (Figures 2, 3, and 4). A one-minute resting period after energy delivery was allowed before moving the catheter. Biliary stents were placed systematically after radiofrequency ablation (Figure 5). Immediate and 30-day complications as well as technical and intraprocedural difficulties were recorded. SAS 9.2 was used to conduct statistical analyses. Figure 1: Fluoroscopic images of bile duct cancer at the confluence with a Bismuth III lesion. Figure 2: EndoHPB Probe for radio frequency ablation. 3. Results Twenty patients (15 males) with a mean age of 65.3 years (range 45–86) were included in the study. A total of 25 malignant biliary strictures were treated with RFA. 11 patients had unresectable cholangiocarcinoma, 7 had unresectable pancreatic cancer, 1 had Intraductal papillary mucinous neoplasm (IPMN) with high grade dysplasia, and 1 had gastric cancer with metastatic tumor in the bile duct. Patient demographics ar (...truncated)