1. Endoscopic versus percutaneous biliary drainage in patients with resectable perihilar cholangiocarcinoma: A multicentre, randomised controlled trial
- Author
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Carlijn I. Buis, Joanne Verheij, Adriaan Moelker, Victor van Woerden, Jan N. M. IJzermans, Rogier de Ridder, Robert J.S. Coelen, G. Matthijs Kater, Marc G. Besselink, Steven W.M. Olde Damink, Erik A.J. Rauws, Dirk J. Gouma, Jeanin E. van Hooft, Marcel G. W. Dijkgraaf, Olivier R. Busch, Robert J. Porte, Cornelis H. C. Dejong, E. Roos, Krijn P. van Lienden, Otto M. van Delden, Jan-Werner Poley, Jimme K. Wiggers, Jan J. Koornstra, Bas Groot Koerkamp, Michiel W. de Haan, Paul Fockens, Casper H.J. van Eijck, Thomas M. van Gulik, Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, Surgery, Graduate School, AGEM - Re-generation and cancer of the digestive system, AGEM - Endocrinology, metabolism and nutrition, CCA - Cancer Treatment and Quality of Life, AGEM - Digestive immunity, Radiology and Nuclear Medicine, Amsterdam Cardiovascular Sciences, Gastroenterology and Hepatology, CCA - Imaging and biomarkers, Pathology, Epidemiology and Data Science, APH - Methodology, CCA - Cancer biology and immunology, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), MUMC+: DA Beeldvorming (5), Beeldvorming, RS: CARIM - R3.11 - Imaging, Interne Geneeskunde, MUMC+: MA Maag Darm Lever (9), Promovendi NTM, Radiology & Nuclear Medicine, Gastroenterology & Hepatology, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Groningen Institute for Organ Transplantation (GIOT), AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Amsterdam Cardiovascular Sciences, Ear, Nose and Throat, and Clinical Research Unit
- Subjects
medicine.medical_specialty ,Percutaneous ,FUTURE LIVER REMNANT ,RESECTION ,SURGERY ,medicine.medical_treatment ,Population ,HEPATECTOMY ,030230 surgery ,HILAR CHOLANGIOCARCINOMA ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,TUMOR ,law ,REGENERATION ,medicine ,Prospective cohort study ,education ,METAANALYSIS ,education.field_of_study ,Hepatology ,medicine.diagnostic_test ,business.industry ,Bile duct ,Gastroenterology ,Jaundice ,Endoscopy ,Surgery ,medicine.anatomical_structure ,SURGICAL-TREATMENT ,030211 gastroenterology & hepatology ,BILE REPLACEMENT ,Hepatectomy ,medicine.symptom ,business - Abstract
Background: In patients with resectable perihilar cholangiocarcinoma, biliary drainage is recommended to treat obstructive jaundice and optimise the clinical condition before liver resection. Little evidence exists on the preferred initial method of biliary drainage. We therefore investigated the incidence of severe drainage-related complications of endoscopic biliary drainage or percutaneous transhepatic biliary drainage in patients with potentially resectable perihilar cholangiocarcinoma. Methods: We did a multicentre, randomised controlled trial at four academic centres in the Netherlands. Patients who were aged at least 18 years with potentially resectable perihilar cholangiocarcinoma requiring major liver resection, and biliary obstruction of the future liver remnant (defined as a bilirubin concentration of >50 μmol/L [2·9 mg/dL]), were randomly assigned (1:1) to receive endoscopic biliary drainage or percutaneous transhepatic biliary drainage through the use of computer-generated allocation. Randomisation, done by the trial coordinator, was stratified for previous (attempted) biliary drainage, the extent of bile duct involvement, and enrolling centre. Patients were enrolled by clinicians of the participating centres. The primary outcome was the number of severe complications between randomisation and surgery in the intention-to-treat population. The trial was registered at the Netherlands National Trial Register, number NTR4243. Findings: From Sept 26, 2013, to April 29, 2016, 261 patients were screened for participation, and 54 eligible patients were randomly assigned to endoscopic biliary drainage (n=27) or percutaneous transhepatic biliary drainage (n=27). The study was prematurely closed because of higher mortality in the percutaneous transhepatic biliary drainage group (11 [41%] of 27 patients) than in the endoscopic biliary drainage group (three [11%] of 27 patients; relative risk 3·67, 95% CI 1·15–11·69; p=0·03). Three of the 11 deaths among patients in the percutaneous transhepatic biliary drainage group occurred before surgery. The proportion of patients with severe preoperative drainage-related complications was similar between the groups (17 [63%] patients in the percutaneous transhepatic biliary drainage group vs 18 [67%] in the endoscopic biliary drainage group; relative risk 0·94, 95% CI 0·64–1·40). 16 (59%) patients in the percutaneous transhepatic biliary drainage group and ten (37%) patients in the endoscopic biliary drainage group developed preoperative cholangitis (p=0·1). 15 (56%) patients required additional percutaneous transhepatic biliary drainage after endoscopic biliary drainage, whereas only one (4%) patient required endoscopic biliary drainage after percutaneous transhepatic biliary drainage. Interpretation: The study was prematurely stopped because of higher all-cause mortality in the percutaneous transhepatic biliary drainage group. Post-drainage complications were similar between groups, but the data should be interpreted with caution because of the small sample size. The results call for further prospective studies and reconsideration of indications and strategy towards biliary drainage in this complex disease. Funding: Dutch Cancer Foundation.
- Published
- 2018