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Eksport do Mediów Społecznościowych

Eksport do Mediów Społecznościowych

Wytyczne postępowania diagnostyczno-terapeutycznego w nowotworach dróg żółciowych

Maciej Krzakowski1, Piotr Potemski2, Michał Grąt3, Maciej Kawecki1, Tomasz Kubiatowski4, Barbara Radecka56, Jarosław Reguła17, Joanna Socha89

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Referencje

  1. Didkowska JA, Wojciechowska U, Barańska K, et al. Nowotwory złośliwe w Polsce w 2021 roku. Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Warszawa 2023.
  2. Rawla P, Sunkara T, Thandra K, et al. Epidemiology of gallbladder cancer. Clin Exp Hepatol. 2019; 5(2): 93–102.
  3. Valle J, Kelley R, Nervi B, et al. Biliary tract cancer. Lancet. 2021; 397(10272): 428–444.
  4. Fassan M, Angerilli V, Normanno N, et al. Practical guidelines for molecular testing of cholangiocarcinoma in clinical practice: Italian experts' position paper. Crit Rev Oncol Hematol. 2024; 194: 104224.
  5. Lowery MA, Ptashkin R, Jordan E, et al. Comprehensive Molecular Profiling of Intrahepatic and Extrahepatic Cholangiocarcinomas: Potential Targets for Intervention. Clin Cancer Res. 2018; 24(17): 4154–4161.
  6. Maynard H, Stadler ZK, Berger MF, et al. Germline alterations in patients with biliary tract cancers: A spectrum of significant and previously underappreciated findings. Cancer. 2020; 126(9): 1995–2002.
  7. NCCN: Biliary tract cancers, version 3.2024. https://www.nccn.org/professionals/physician_gls/pdf/btc.pdf.
  8. Terashima T, Umemoto K, Takahashi H, et al. Germline mutations in cancer-predisposition genes in patients with biliary tract cancer. Oncotarget. 2019; 10(57): 5949–5957.
  9. Vogel A, Bridgewater J, Edeline J, et al. ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023; 34(2): 127–140.
  10. Arechederra M, Rullán M, Amat I, et al. Next-generation sequencing of bile cell-free DNA for the early detection of patients with malignant biliary strictures. Gut. 2021; 71(6): 1141–1151.
  11. Arnelo U, von Seth E, Bergquist A. Prospective evaluation of the clinical utility of single-operator peroral cholangioscopy in patients with primary sclerosing cholangitis. Endoscopy. 2015; 47(8): 696–702.
  12. Baniukiewcz A, Kurek K. Cholangiopankreatoskopia u życiem systemu „SpyGlass” – evidence-based Medicine. Gastroenterologia Kliniczna. 2019; 11: 24–28.
  13. Bowlus CL, Arrivé L, Bergquist A, et al. AASLD practice guidance on primary sclerosing cholangitis and cholangiocarcinoma. Hepatology. 2023; 77(2): 659–702.
  14. Cadamuro M, Al-Taee A, Gonda TA. Advanced endoscopy meets molecular diagnosis of cholangiocarcinoma. J Hepatol. 2023; 78(5): 1063–1072.
  15. Gao DJ, Yang JF, Ma SR, et al. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021; 94(1): 91–100.e2.
  16. Kodali S, Connor AA, Brombosz EW, et al. Update on the Screening, Diagnosis, and Management of Cholangiocarcinoma. Gastroenterol Hepatol (N Y). 2024; 20(3): 151–158.
  17. Lowe RC, Anderson CD, Kowdley KV. Clinical manifestations and diagnosis of cholangiocarcinoma. UpToDate 2024: Jul 2024.
  18. Rimassa L, Brandi G, Niger M, et al. Delphi Panel Members. Diagnosis and treatment of cholangiocarcinoma in Italy: A Delphi consensus statement. Crit Rev Oncol Hematol. 2023; 192: 104146.
  19. Vogel A, Bridgewater J, Edeline J, et al. ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023; 34(2): 127–140.
  20. Aliseda D, Sapisochin G, Martí-Cruchaga P, et al. Association of Laparoscopic Surgery with Improved Perioperative and Survival Outcomes in Patients with Resectable Intrahepatic Cholangiocarcinoma: A Systematic Review and Meta-Analysis from Propensity-Score Matched Studies. Ann Surg Oncol. 2023; 30(8): 4888–4901.
  21. Amin MB, Greene FL, Edge SB, et al. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017; 67(2): 93–99.
  22. Coelen RJS, Roos E, Wiggers JK, et al. Endoscopic versus percutaneous biliary drainage in patients with resectable perihilar cholangiocarcinoma: a multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2018; 3(10): 681–690.
  23. Ethun CG, Lopez-Aguiar AG, Anderson DJ, et al. Transplantation Versus Resection for Hilar Cholangiocarcinoma: An Argument for Shifting Treatment Paradigms for Resectable Disease. Ann Surg. 2018; 267(5): 797–805.
  24. Ethun CG, Postlewait LM, Le N, et al. Association of Optimal Time Interval to Re-resection for Incidental Gallbladder Cancer With Overall Survival: A Multi-Institution Analysis From the US Extrahepatic Biliary Malignancy Consortium. JAMA Surg. 2017; 152(2): 143–149.
  25. Ethun CG, Postlewait LM, Le N, et al. Routine port-site excision in incidentally discovered gallbladder cancer is not associated with improved survival: A multi-institution analysis from the US Extrahepatic Biliary Malignancy Consortium. J Surg Oncol. 2017; 115(7): 805–811.
  26. Franssen S, Soares KC, Jolissaint JS, et al. Comparison of Hepatic Arterial Infusion Pump Chemotherapy vs Resection for Patients With Multifocal Intrahepatic Cholangiocarcinoma. JAMA Surg. 2022; 157(7): 590–596.
  27. Gilbert RWD, Lenet T, Cleary SP, et al. Does Caudate Resection Improve Outcomes of Patients Undergoing Curative Resection for Perihilar Cholangiocarcinoma? A Systematic Review and Meta-Analysis. Ann Surg Oncol. 2022; 29(11): 6759–6771.
  28. Goere D, Wagholikar GD, Pessaux P, et al. Utility of staging laparoscopy in subsets of biliary cancers : laparoscopy is a powerful diagnostic tool in patients with intrahepatic and gallbladder carcinoma. Surg Endosc. 2006; 20(5): 721–725.
  29. Ishii T, Iwaki K, Nakakura A, et al. Is routine lymph node dissection recommended for liver resection of intrahepatic cholangiocarcinoma? A systematic review and meta-analysis. HPB (Oxford). 2024; 26(6): 731–740.
  30. Jiang JH, Fang DZ, Hu YT. Influence of surgical margin width on survival rate after resection of intrahepatic cholangiocarcinoma: a systematic review and meta-analysis. BMJ Open. 2023; 13(5): e067222.
  31. Kasumova GG, Tabatabaie O, Najarian RM, et al. Surgical Management of Gallbladder Cancer: Simple Versus Extended Cholecystectomy and the Role of Adjuvant Therapy. Ann Surg. 2017; 266(4): 625–631.
  32. Ke Q, Wang L, Lin Z, et al. Anatomic versus non-anatomic resection for early-stage intrahepatic cholangiocarcinoma: a propensity score matching and stabilized inverse probability of treatment weighting analysis. BMC Cancer. 2023; 23(1): 850.
  33. 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(5): 445–451.
  34. Konstadoulakis MM, Roayaie S, Gomatos IP, et al. Fifteen-year, single-center experience with the surgical management of intrahepatic cholangiocarcinoma: operative results and long-term outcome. Surgery. 2008; 143(3): 366–374.
  35. Kwon W, Kim H, Han Y, et al. Role of tumour location and surgical extent on prognosis in T2 gallbladder cancer: an international multicentre study. Br J Surg. 2020; 107(10): 1334–1343.
  36. Lee SE, Jang JY, Lim CS, et al. Systematic review on the surgical treatment for T1 gallbladder cancer. World J Gastroenterol. 2011; 17(2): 174–180.
  37. Lenet T, Gilbert RWD, Smoot R, et al. Does Intraoperative Frozen Section and Revision of Margins Lead to Improved Survival in Patients Undergoing Resection of Perihilar Cholangiocarcinoma? A Systematic Review and Meta-analysis. Ann Surg Oncol. 2022; 29(12): 7592–7602.
  38. Chen RX, Li CX, Luo CH, et al. Surgical Strategies for the Treatment of Bismuth Type I and II Hilar Cholangiocarcinoma: Bile Duct Resection with or Without Hepatectomy? Ann Surg Oncol. 2020; 27(9): 3374–3382.
  39. Li D, Xu Li, Deng X, et al. Laparoscopic versus open surgery in treating patients with gallbladder cancer: a systematic review and meta-analysis. Hepatobiliary Surg Nutr. 2024; 13(3): 444–459.
  40. Lv TR, Liu F, Hu HJ, et al. The role of extra-hepatic bile duct resection in the surgical management of gallbladder carcinoma. A first meta-analysis. Eur J Surg Oncol. 2022; 48(3): 482–491.
  41. Matsui S, Tanioka T, Nakajima K, et al. Surgical and Oncological Outcomes of Wedge Resection Versus Segment 4b + 5 Resection for T2 and T3 Gallbladder Cancer: a Meta-Analysis. J Gastrointest Surg. 2023; 27(9): 1954–1962.
  42. McMillan RR, Javle M, Kodali S, et al. Survival following liver transplantation for locally advanced, unresectable intrahepatic cholangiocarcinoma. Am J Transplant. 2022; 22(3): 823–832.
  43. Nasser-Ghodsi N, Eaton JE, Smith BH, et al. Transplantation Within 6 Months of Registration does not Enhance Survival for Patients with Perihilar Cholangiocarcinoma. Ann Surg. 2024 [Epub ahead of print].
  44. Nishio H, Ebata T, Yokoyama Y, et al. Gallbladder cancer involving the extrahepatic bile duct is worthy of resection. Ann Surg. 2011; 253(5): 953–960.
  45. Oh MY, Kim H, Sohn HJu, et al. Long-Term Oncologic Outcomes for T2 Gallbladder Cancer According to the Type of Surgery Performed and the Optimal Timing for Sequential Extended Cholecystectomy. J Gastrointest Surg. 2022; 26(8): 1705–1712.
  46. Park Y, Lee JS, Lee B, et al. Prognostic Effect of Liver Resection in Extended Cholecystectomy for T2 Gallbladder Cancer Revisited: A Retrospective Cohort Study With Propensity Score-matched Analysis. Ann Surg. 2023; 278(6): 985–993.
  47. Ren T, Li YS, Dang XY, et al. Prognostic significance of regional lymphadenectomy in T1b gallbladder cancer: Results from 24 hospitals in China. World J Gastrointest Surg. 2021; 13(2): 176–186.
  48. Ruff SM, Cloyd JM, Pawlik TM. Annals of Surgical Oncology Practice Guidelines Series: Management of Primary Liver and Biliary Tract Cancers. Ann Surg Oncol. 2023; 30(13): 7935–7949.
  49. Sapisochin G, Facciuto M, Rubbia-Brandt L, et al. iCCA International Consortium. Liver transplantation for "very early" intrahepatic cholangiocarcinoma: International retrospective study supporting a prospective assessment. Hepatology. 2016; 64(4): 1178–1188.
  50. Shao J, Lu HC, Wu LQ, et al. Simple cholecystectomy is an adequate treatment for grade I T1bN0M0 gallbladder carcinoma: Evidence from 528 patients. World J Gastroenterol. 2022; 28(31): 4431–4441.
  51. Si A, Li J, Yang Z, et al. Impact of Anatomical Versus Non-anatomical Liver Resection on Short- and Long-Term Outcomes for Patients with Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. 2019; 26(6): 1841–1850.
  52. Soares KC, Jarnagin WR. The Landmark Series: Hilar Cholangiocarcinoma. Ann Surg Oncol. 2021; 28(8): 4158–4170.
  53. Sposito C, Droz Dit Busset M, Virdis M, et al. The role of lymphadenectomy in the surgical treatment of intrahepatic cholangiocarcinoma: A review. Eur J Surg Oncol. 2022; 48(1): 150–159.
  54. Tian Y, Liu L, Yeolkar NV, et al. Diagnostic role of staging laparoscopy in a subset of biliary cancers: a meta-analysis. ANZ J Surg. 2017; 87(1-2): 22–27.
  55. Uijterwijk BA, Lemmers DHL, Bolm L, et al. ISGACA consortium, the International study group on non-pancreatic periampullary cancer. Long-term Outcomes After Laparoscopic, Robotic, and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: An International Propensity Score-matched Cohort Study. Ann Surg. 2023; 278(3): e570–e579.
  56. Vega EA, Mellado S, Chirban AM, et al. Analysis of the Extent of Liver Oncological Extended Resection for Incidental Gallbladder Cancer: How Much Is Too Much? Ann Surg Oncol. 2023; 30(11): 6594–6600.
  57. Wang C, Ciren P, Danzeng A, et al. Anatomical Resection Improved the Outcome of Intrahepatic Cholangiocarcinoma: A Propensity Score Matching Analysis of a Retrospective Cohort. J Oncol. 2022; 2022: 4446243.
  58. Wiggers JK, Groot Koerkamp B, Cieslak KP, et al. Postoperative Mortality after Liver Resection for Perihilar Cholangiocarcinoma: Development of a Risk Score and Importance of Biliary Drainage of the Future Liver Remnant. J Am Coll Surg. 2016; 223(2): 321–331.e1.
  59. Yasukawa K, Shimizu A, Motoyama H, et al. Impact of Remnant Carcinoma in Situ at the Ductal Stump on Long-Term Outcomes in Patients with Distal Cholangiocarcinoma. World J Surg. 2021; 45(1): 291–301.
  60. Yin L, Zhao Si, Zhu H, et al. Primary tumor resection improves survival in patients with multifocal intrahepatic cholangiocarcinoma based on a population study. Sci Rep. 2021; 11(1): 12166.
  61. Zhang XF, Bagante F, Chakedis J, et al. Perioperative and Long-Term Outcome for Intrahepatic Cholangiocarcinoma: Impact of Major Versus Minor Hepatectomy. J Gastrointest Surg. 2017; 21(11): 1841–1850.
  62. Ziogas IA, Giannis D, Economopoulos KP, et al. Liver Transplantation for Intrahepatic Cholangiocarcinoma: A Meta-analysis and Meta-regression of Survival Rates. Transplantation. 2021; 105(10): 2263–2271.
  63. Ben-Josef E, Guthrie KA, El-Khoueiry AB, et al. SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma. J Clin Oncol. 2015; 33(24): 2617–2622.
  64. Engineer R, Goel M, Chopra S, et al. Neoadjuvant Chemoradiation Followed by Surgery for Locally Advanced Gallbladder Cancers: A New Paradigm. Ann Surg Oncol. 2016; 23(9): 3009–3015.
  65. Frakulli R, Buwenge M, Macchia G, et al. Stereotactic body radiation therapy in cholangiocarcinoma: a systematic review. Br J Radiol. 2019; 92(1097): 20180688.
  66. Hong TS, Wo JY, Yeap BY, et al. Multi-Institutional Phase II Study of High-Dose Hypofractionated Proton Beam Therapy in Patients With Localized, Unresectable Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma. J Clin Oncol. 2016; 34(5): 460–468.
  67. Horgan AM, Amir E, Walter T, et al. Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012; 30(16): 1934–1940.
  68. Kim BH, Kwon J, Chie EK, et al. Adjuvant Chemoradiotherapy is Associated with Improved Survival for Patients with Resected Gallbladder Carcinoma: A Systematic Review and Meta-analysis. Ann Surg Oncol. 2018; 25(1): 255–264.
  69. Phelip JM, Vendrely V, Rostain F, et al. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Fédération Francophone de Cancérologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014; 50(17): 2975–2982.
  70. Ren B, Guo Qi, Yang Y, et al. A meta-analysis of the efficacy of postoperative adjuvant radiotherapy versus no radiotherapy for extrahepatic cholangiocarcinoma and gallbladder carcinoma. Radiat Oncol. 2020; 15(1): 15.
  71. Abou-Alfa GK, Macarulla T, Javle MM, et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020; 21(6): 796–807.
  72. Bibeau K, Féliz L, Lihou CF, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020; 21(5): 671–684.
  73. Bridgewater J, Fletcher P, Palmer DH, et al. BILCAP study group. Long-Term Outcomes and Exploratory Analyses of the Randomized Phase III BILCAP Study. J Clin Oncol. 2022; 40(18): 2048–2057.
  74. Drilon A, Chiu CH, Fan Y, et al. trial investigators, trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020; 21(2): 271–282.
  75. Ebata T, Hirano S, Konishi M, et al. Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018; 105(3): 192–202.
  76. Edeline J, Benabdelghani M, Bertaut A, et al. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019; 37(8): 658–667.
  77. Goyal L, Meric-Bernstam F, Hollebecque A, et al. FOENIX-CCA2 Study Investigators. Futibatinib for -Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023; 388(3): 228–239.
  78. Hakeem AR, Papoulas M, Menon KV. The role of neoadjuvant chemotherapy or chemoradiotherapy for advanced gallbladder cancer - A systematic review. Eur J Surg Oncol. 2019; 45(2): 83–91.
  79. Hong DS, DuBois SG, Kummar S, et al. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncol. 2020; 21(4): 531–540.
  80. Javle M, Borad MJ, Azad NS, et al. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021; 22(9): 1290–1300.
  81. Kelley RK, Ueno M, Yoo C, et al. KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023; 401(10391): 1853–1865.
  82. Komaya K, Ebata T, Shirai K, et al. Nagoya Surgical Oncology Group. Recurrence after resection with curative intent for distal cholangiocarcinoma. Br J Surg. 2017; 104(4): 426–433.
  83. Lamarca A, Palmer DH, Wasan HS, et al. Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021; 22(5): 690–701.
  84. Maio M, Ascierto PA, Manzyuk L, et al. Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. Ann Oncol. 2022; 33(9): 929–938.
  85. Mavros MN, Economopoulos KP, Alexiou VG, et al. Treatment and Prognosis for Patients With Intrahepatic Cholangiocarcinoma: Systematic Review and Meta-analysis. JAMA Surg. 2014; 149(6): 565–574.
  86. Meric-Bernstam F, Makker V, Oaknin A, et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol. 2024; 42(1): 47–58.
  87. Nakachi K, Ikeda M, Konishi M, et al. Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG). Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2023; 401(10372): 195–203.
  88. Oh DY, Ruth He A, Qin S, et al. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022; 1(8): EVIDoa2200015.
  89. Primrose JN, Fox RP, Palmer DH, et al. BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019; 20(5): 663–673.
  90. Sharma A, Kalyan Mohanti B, Pal Chaudhary S, et al. Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin in unresectable gallbladder cancer: Results of a phase III randomised controlled trial. Eur J Cancer. 2019; 123: 162–170.
  91. Shroff RT, Kennedy EB, Bachini M, et al. Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline. J Clin Oncol. 2019; 37(12): 1015–1027.
  92. Subbiah V, Lassen U, Élez E, et al. Dabrafenib plus trametinib in patients with BRAF-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020; 21(9): 1234–1243.
  93. Tran Cao HS, Zhang Q, Sada YH, et al. The role of surgery and adjuvant therapy in lymph node-positive cancers of the gallbladder and intrahepatic bile ducts. Cancer. 2018; 124(1): 74–83.
  94. Valle J, Wasan H, Palmer DH, et al. ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010; 362(14): 1273–1281.
  95. Vogel A, Bridgewater J, Edeline J, et al. ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023; 34(2): 127–140.
  96. Yoo C, Kim KP, Jeong JHo, et al. Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study. Lancet Oncol. 2021; 22(11): 1560–1572.
  97. Primrose JN, Fox RP, Palmer DH, et al. BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019; 20(5): 663–673.