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
References
[1]
J. R. Andersen, S. M. Sorensen, A. Kruse, M. Rokkjaer, and P. Matzen, “Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice,” Gut, vol. 30, no. 8, pp. 1132–1135, 1989.
[2]
H. A. Shepherd, G. Royle, A. P. R. Ross, A. Diba, M. Arthur, and D. Colin-Jones, “Endoscopic biliary endoprosthesis in the palliation of malignant obstruction of the distal common bile duct: a randomized trial,” British Journal of Surgery, vol. 75, no. 12, pp. 1166–1168, 1988.
[3]
P. H. P. Davids, A. K. Groen, E. A. J. Rauws, G. N. J. Tytgat, and K. Huibregtse, “Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction,” The Lancet, vol. 340, no. 8834-8835, pp. 1488–1492, 1992.
[4]
S. O'Brien, A. R. W. Hatfield, P. I. Craig, and S. P. Williams, “A three year follow up of self expanding metal stents in the endoscopic palliation of longterm survivors with malignant biliary obstruction,” Gut, vol. 36, no. 4, pp. 618–621, 1995.
[5]
P. Rossi, M. Bezzi, M. Rossi et al., “Metallic stents in malignant biliary obstruction: results of a multicenter European study of 240 patients,” Journal of Vascular and Interventional Radiology, vol. 5, no. 2, pp. 279–285, 1994.
[6]
M. Kahaleh, J. Tokar, M. R. Conaway et al., “Efficacy and complications of covered Wallstents in malignant distal biliary obstruction,” Gastrointestinal Endoscopy, vol. 61, no. 4, pp. 528–533, 2005.
[7]
W. J. Yoon, J. K. Lee, K. H. Lee et al., “A comparison of covered and uncovered Wallstents for the management of distal malignant biliary obstruction,” Gastrointestinal Endoscopy, vol. 63, no. 7, pp. 996–1000, 2006.
[8]
A. Hatzidakis, M. Krokidis, K. Kalbakis, J. Romanos, I. Petrakis, and N. Gourtsoyiannis, “ePTFE/FEP-covered metallic stents for palliation of malignant biliary disease: can tumor ingrowth be prevented?” CardioVascular and Interventional Radiology, vol. 30, no. 5, pp. 950–958, 2007.
[9]
H. Isayama, Y. Komatsu, T. Tsujino, et al., “A prospective randomized study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction,” Gut, vol. 53, no. 5, pp. 729–734, 2004.
[10]
K. T. Suk, H. S. Kim, J. W. Kim et al., “Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction,” Gastrointestinal Endoscopy, vol. 64, no. 4, pp. 522–529, 2006.
[11]
B. J. Loew, D. A. Howell, M. K. Sanders et al., “Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial,” Gastrointestinal Endoscopy, vol. 70, no. 3, pp. 445–453, 2009.
[12]
M. E. J. Ortner, K. Caca, F. Berr et al., “Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study,” Gastroenterology, vol. 125, no. 5, pp. 1355–1363, 2003.
[13]
S. P. Pereira, L. Ayaru, A. Rogowska, A. Mosse, A. R. W. Hatfield, and S. G. Bown, “Photodynamic therapy of malignant biliary strictures using meso-tetrahydroxyphenylchlorin,” European Journal of Gastroenterology and Hepatology, vol. 19, no. 6, pp. 479–485, 2007.
[14]
T. Zoepf, R. Jakobs, J. C. Arnold, D. Apel, and J. F. Riemann, “Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy,” American Journal of Gastroenterology, vol. 100, no. 11, pp. 2426–2430, 2005.
[15]
S. E. Khorsandi, D. Zacharoulis, P. Vavra, et al., “The modern use of radiofrequency energy in surgery, endoscopy and interventional radiology,” European Surgery, vol. 40, no. 5, pp. 204–210, 2008.
[16]
P. Vavra, J. Dostalik, D. Zacharoulis, S. E. Khorsandi, S. A. Khan, and N. A. Habib, “Endoscopic radiofrequency ablation in colorectal cancer: initial clinical results of a new bipolar radiofrequency ablation device,” Diseases of the Colon and Rectum, vol. 52, no. 2, pp. 355–358, 2009.
[17]
L. M. Sutherland, J. A. R. Williams, R. T. A. Padbury, D. C. Gotley, B. Stokes, and G. J. Maddern, “Radiofrequency ablation of liver tumors: a systematic review,” Archives of Surgery, vol. 141, no. 2, pp. 181–190, 2006.
[18]
A. W. Steel, A. J. Postgate, P. Vivianos, et al., “The use of a novel endoscopically placed radiofrequency probe for the management of malignant bile duct obstruction,” Gastrointestinal Endoscopy, vol. 71, no. 5, Article ID AB321, 2010.
[19]
S. E. Khorsandi, “In vivo experiments for the development of a novel bipolar radiofrequency probe (EndoHPB) for the palliation of malignant biliary obstruction,” in EASL Monothematic Conference. Liver Cancer: From Molecular Pathogenesis to New Therapies, p. 97, 2008.
[20]
A. W. Steel, A. J. Postgate, S. Khorsandi et al., “Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction,” Gastrointestinal Endoscopy, vol. 73, no. 1, pp. 149–153, 2011.
