American Journal of Gastroenterology ISSN 0002-9270 C 2006 by Am. Coll. of Gastroenterology doi: 10.1111/j.1572-0241.2006.00700.x Published by Blackwell Publishing A Novel Endoscopic Approach to Brachytherapy in the Management of Hilar Cholangiocarcinoma Dia T. Simmons, M.D., 1 Todd H. Baron, M.D., 1 Bret T. Petersen, M.D., 1 Christopher J. Gostout, M.D., 1 Michael G. Haddock, M.D., 2 Gregory J. Gores, M.D., 1 Peter D. Yeakel, CDM, 2 Mark D. Topazian, M.D., 1 and Michael J. Levy, M.D. 1 1 Department of Medicine, Division of Gastroenterology & Hepatology; and 2 Department of Radiation Oncology, Mayo Clinic College of Medicine, Rochester, Minnesota OBJECTIVES: Traditionally, biliary brachytherapy sources are placed percutaneously via transhepatic drains or endoscopically via nasobiliary tubes (NBT). Another ERCP is needed for stent replacement after NBT removal. The aim of this study was to determine the feasibility and safety of endoscopic transpapillary insertion of irradiation sources through 10-Fr stents. METHODS: Medical records of Mayo Clinic Rochester patients undergoing biliary brachytherapy for hilar cholangiocarcinoma (CCA) were reviewed. Patients were part of a treatment protocol with curative intent including external beam radiation therapy (4,500 cGy), radiation sensitization (5-FU), and low dose rate (LDR) brachytherapy (<3,000 cGy) followed by liver transplantation. The 10-Fr biliary stent placed across the malignant biliary stricture was directly cannulated using a radiopaque 192 Ir embedded ribbon within a 300-cm long, 5.1-Fr plastic sheath. After withdrawal of the endoscope, the external end of the brachytherapy catheter was rerouted transnasally and secured. Each patient was hospitalized in a shielded room up to 24 h after which the brachytherapy catheter was removed by hand. RESULTS: Between 1999 and 2004, 32 patients underwent biliary brachytherapy via endoscopically placed 10-Fr plastic stents (mean age 50.6 yr, 69% PSC, bilateral brachytherapy catheters 28.1%). The technical complication observed was immediate brachytherapy catheter displacement (7 of 32, 22%) managed by prompt brachytherapy catheter repositioning. CONCLUSION: LDR biliary brachytherapy administration via endoscopically placed biliary stents is technically feasible and appears reasonably safe in select patients with unresectable perihilar CCA. Unlike NBTs, stents can potentially be placed in bilateral ductal systems to accommodate dual brachytherapy catheters when indicated. (Am J Gastroenterol 2006;101:1792–1796) INTRODUCTION Cholangiocarcinoma (CCA) is a relatively rare cancer with a poor prognosis. The most important risk factor for the de- velopment of CCA, primary sclerosing cholangitis (PSC), is associated with a 0.5–1.5% annual risk of CCA (1) (Fig. 1). When the cancer is resectable, the 5-yr survival ranges from 0% to 40%, though is only 10% in the setting of PSC. The overall 5-yr survival is less than 10% and the majority of patients have unresectable disease. Perihilar CCA is considered unresectable when complete tumor excision is not possible with subtotal hepatectomy. In the past, some patients with CCA were offered liver resection and transplantation. Unfortunately, CCA recur- rence and mortality rates were unacceptably high. This led to the consideration of CCA as a contraindication to liver transplantation. In recent years, a few investigators have shown that se- lect patients with unresectable but relatively localized CCA (without local extension, extrahepatic or lymph node metas- tases) may benefit from transplantation when neoadjuvant chemoradiation is administered. In 2005, our group published data showing survival of 92% at 1 yr and 82% at 5 yr after liver transplant for the 38 patients treated with neoadjuvant chemoradiation, including biliary brachytherapy, followed by orthotopic liver transplantation for CCA (2). The current treatment protocol at Mayo incorporates external beam ra- diation therapy (EBRT), radiation sensitization with 5-FU, low dose rate (LDR) intraluminal brachytherapy (ILBT), and a careful staging laparotomy followed by immediate listing for transplant. LDR biliary brachytherapy requires that radioactive sources be temporarily placed into the bile duct for deliv- ery of a prescribed dose of radiation. Previous reports of 1792