Preoperative biliary drainage in perihilar cholangiocarcinoma: identifying patients who require percutaneous drainage after failed endoscopic drainage

Background and study aims: Preoperative biliary drainage is often initiated with endoscopic retrograde cholangiopancreatography (ERCP) in patients with potentially resectable perihilar cholangiocarcinoma (PHC), but additional percutaneous transhepatic catheter (PTC) drainage is frequently required. This study aimed to develop and validate a prediction model to identify patients with a high risk of inadequate ERCP drainage.

Patients and methods: Patients with potentially resectable PHC and (attempted) preoperative ERCP drainage were included from two specialty center cohorts between 2001 and 2013. Indications for additional PTC drainage were failure to place an endoscopic stent, failure to relieve jaundice, cholangitis, or insufficient drainage of the future liver remnant. A prediction model was derived from the European cohort and externally validated in the USA cohort.

Results: Of the 288 patients, 108 (38 %) required additional preoperative PTC drainage after inadequate ERCP drainage. Independent risk factors for additional PTC drainage were proximal biliary obstruction on preoperative imaging (Bismuth 3 or 4) and predrainage total bilirubin level. The prediction model identified three subgroups: patients with low risk (7 %), moderate risk (40 %), and high risk (62 %). The high-risk group consisted of patients with a total bilirubin level above 150 µmol/L and Bismuth 3a or 4 tumors, who typically require preoperative drainage of the angulated left bile ducts. The prediction model had good discrimination (area under the curve 0.74) and adequate calibration in the external validation cohort.

Conclusions: Selected patients with potentially resectable PHC have a high risk (62 %) of inadequate preoperative ERCP drainage requiring additional PTC drainage. These patients might do better with initial PTC drainage instead of ERCP.

• References

• 1 Valle J, Wasan H, Palmer DH et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. NEJM 2010; 362: 1273-1281
• 2 Ebata T, Kosuge T, Hirano S et al. Proposal to modify the International Union Against Cancer staging system for perihilar cholangiocarcinomas. Br J Surg 2014; 101: 79-88
• 3 Matsuo K, Rocha FG, Ito K et al. The Blumgart preoperative staging system for hilar cholangiocarcinoma: analysis of resectability and outcomes in 380 patients. J Am Coll Surg 2012; 215: 343-355
• 4 Nuzzo G, Giuliante F, Ardito F et al. Improvement in perioperative and long-term outcome after surgical treatment of hilar cholangiocarcinoma: results of an Italian multicenter analysis of 440 patients. Arch Surg 2012; 147: 26-34
• 5 Nagino M, Ebata T, Yokoyama Y et al. Evolution of surgical treatment for perihilar cholangiocarcinoma: a single-center 34-year review of 574 consecutive resections. Ann Surg 2013; 258: 129-140
• 6 Kennedy TJ, Yopp A, Qin Y et al. Role of preoperative biliary drainage of liver remnant prior to extended liver resection for hilar cholangiocarcinoma. HPB (Oxford) 2009; 11: 445-451
• 7 Farges O, Regimbeau JM, Fuks D et al. Multicentre European study of preoperative biliary drainage for hilar cholangiocarcinoma. Br J Surg 2013; 100: 274-283
• 8 Neuhaus P, Thelen A, Jonas S et al. Oncological superiority of hilar en bloc resection for the treatment of hilar cholangiocarcinoma. Ann Surg Oncol 2012; 19: 1602-1608
• 9 Kaiser GM, Paul A, Sgourakis G et al. Novel prognostic scoring system after surgery for Klatskin tumor. Am Surg 2013; 79: 90-95
• 10 Nagino M, Kamiya J, Uesaka K et al. Complications of hepatectomy for hilar cholangiocarcinoma. World J Surg 2001; 25: 1277-1283
• 11 Sakata J, Shirai Y, Tsuchiya Y et al. Preoperative cholangitis independently increases in-hospital mortality after combined major hepatic and bile duct resection for hilar cholangiocarcinoma. Langenbecks Arch Surg 2009; 394: 1065-1072
• 12 Iacono C, Ruzzenente A, Campagnaro T et al. Role of preoperative biliary drainage in jaundiced patients who are candidates for pancreatoduodenectomy or hepatic resection: highlights and drawbacks. Ann Surg 2013; 257: 191-204
• 13 Kloek JJ, van der Gaag NA, Aziz Y et al. Endoscopic and percutaneous preoperative biliary drainage in patients with suspected hilar cholangiocarcinoma. J Gastrointest Surg 2010; 14: 119-125
• 14 Kawakami H, Kuwatani M, Onodera M et al. Endoscopic nasobiliary drainage is the most suitable preoperative biliary drainage method in the management of patients with hilar cholangiocarcinoma. J Gastroenterol 2011; 46: 242-248
• 15 Khan SA, Davidson BR, Goldin RD et al. Guidelines for the diagnosis and treatment of cholangiocarcinoma: an update. Gut 2012; 61: 1657-1669
• 16 Dumonceau J-M, Tringali A, Blero D et al. Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy 2012; 44: 277-298
• 17 van Gulik TM, Kloek JJ, Ruys AT et al. Multidisciplinary management of hilar cholangiocarcinoma (Klatskin tumor): extended resection is associated with improved survival. Eur J Surg Oncol 2011; 37: 65-71
• 18 Charlson ME, Pompei P, Ales KL et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987; 40: 373-383
• 19 Bismuth H, Corlette MB. Intrahepatic cholangioenteric anastomosis in carcinoma of the hilus of the liver. Surg Gynecol Obstet 1975; 140: 170-178
• 20 Bismuth H, Nakache R, Diamond T. Management strategies in resection for hilar cholangiocarcinoma. Ann Surg 1992; 215: 31-38
• 21 Vergouwe Y, Royston P, Moons KGM et al. Development and validation of a prediction model with missing predictor data: a practical approach. J Clin Epidemiol 2010; 63: 205-214
• 22 Rubin DB. Multiple imputation for nonresponse in surveys. New York: Wiley; 1987
• 23 Budczies J, Klauschen F, Sinn BV et al. Cutoff Finder: a comprehensive and straightforward Web application enabling rapid biomarker cutoff optimization. PLoS One 2012; 7: e51862
• 24 Cover T, Hart P. Nearest neighbor pattern classification. Information Theory, IEEE Transactions on 1967; 13: 21-27
• 25 Steyerberg ES. Clinical prediction models. New York: Springer; 2009
• 26 van der Gaag NA, Rauws EA, van Eijck CH et al. Preoperative biliary drainage for cancer of the head of the pancreas. NEJM 2010; 362: 129-137
• 27 Paik WH, Park YS, Hwang JH et al. Palliative treatment with self-expandable metallic stents in patients with advanced type III or IV hilar cholangiocarcinoma: a percutaneous versus endoscopic approach. Gastrointest Endosc 2009; 69: 55-62
• 28 Vienne A, Hobeika E, Gouya H et al. Prediction of drainage effectiveness during endoscopic stenting of malignant hilar strictures: the role of liver volume assessment. Gastrointest Endosc 2010; 72: 728-735
• 29 Friedman J, Hastie T, Tibshirani R et al. The elements of statistical learning data mining, inference, and prediction. In: Springer series in statistics. New York, NY: Springer-Verlag; 2009
• 30 Janssen KJM, Donders ART, Harrell FE et al. Missing covariate data in medical research: to impute is better than to ignore. J Clin Epidemiol 2010; 63: 721-727
• 31 Kawashima H, Itoh A, Ohno E et al. Preoperative endoscopic nasobiliary drainage in 164 consecutive patients with suspected perihilar cholangiocarcinoma: a retrospective study of efficacy and risk factors related to complications. Ann Surg 2013; 257: 121-127
• 32 Hwang S, Song G-W, Ha T-Y et al. Reappraisal of percutaneous transhepatic biliary drainage tract recurrence after resection of perihilar bile duct cancer. World J Surg 2012; 36: 379-385
• 33 Takahashi Y, Nagino M, Nishio H et al. Percutaneous transhepatic biliary drainage catheter tract recurrence in cholangiocarcinoma. Br J Surg 2010; 97: 1860-1866
• 34 Wiggers JK, Coelen RJS, Rauws EA et al. Preoperative endoscopic versus percutaneous transhepatic biliary drainage in potentially resectable perihilar cholangiocarcinoma (DRAINAGE trial): design and rationale of a randomized controlled trial. BMC Gastroenterology 2015; 15: 20