Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. BJS 2018; 105: 192-202.
Published: 5th February 2018
Authors: T. Ebata, S. Hirano, M. Konishi, K. Uesaka, Y. Tsuchiya, M. Ohtsuka et al.
Although some retrospective studies have suggested the value of adjuvant therapy, no recommended standard exists in bile duct cancer. The aim of this study was to test the hypothesis that adjuvant gemcitabine chemotherapy would improve survival probability in resected bile duct cancer.
This was a randomized phase III trial. Patients with resected bile duct cancer were assigned randomly to gemcitabine and observation groups, which were balanced with respect to lymph node status, residual tumour status and tumour location. Gemcitabine was given intravenously at a dose of 1000 mg/m2, administered on days 1, 8 and 15 every 4 weeks for six cycles. The primary endpoint was overall survival, and secondary endpoints were relapse‐free survival, subgroup analysis and toxicity.
Some 225 patients were included (117 gemcitabine, 108 observation). Baseline characteristics were well balanced between the gemcitabine and observation groups. There were no significant differences in overall survival (median 62·3
The survival probability in patients with resected bile duct cancer was not significantly different between the gemcitabine adjuvant chemotherapy group and the observation group. Registration number: UMIN 000000820 (
You may also be interested in
Clinical value of additional resection of a margin‐positive distal bile duct in perihilar cholangiocarcinoma. BJS 2019; 106: 774-782.
Authors: S. Otsuka, T. Ebata, Y. Yokoyama, T. Mizuno, T. Tsukahara, Y. Shimoyama et al.
Authors: W. S. Tummers, J. V. Groen, B. G. Sibinga Mulder, A. Farina‐Sarasqueta, J. Morreau, H. Putter et al.
Multicentre study of multidisciplinary team assessment of pancreatic cancer resectability and treatment allocation. BJS 2019; 106: 756-764.
Authors: J. Kirkegård, E. K. Aahlin, M. Al‐Saiddi, S. O. Bratlie, M. Coolsen, R. J. de Haas et al.
Outcomes following pancreatic surgery using three different thromboprophylaxis regimens. BJS 2019; 106: 765-773.
Authors: R. G. Hanna‐Sawires, J. V. Groen, F. A. Klok, R. A. E. M. Tollenaar, W. E. Mesker, R. J. Swijnenburg et al.
Major hepatectomy with or without pancreatoduodenectomy for advanced gallbladder cancer. BJS 2019; 106: 626-635.
Authors: T. Mizuno, T. Ebata, Y. Yokoyama, T. Igami, J. Yamaguchi, S. Onoe et al.
Systematic review of clinical prediction models for survival after surgery for resectable pancreatic cancer. BJS 2019; 106: 342-354.
Authors: M. Strijker, J. W. Chen, T. H. Mungroop, N. B. Jamieson, C. H. van Eijck, E. W. Steyerberg et al.
Randomized clinical trial
Randomized trial of oral versus enteral feeding for patients with postoperative pancreatic fistula after pancreatoduodenectomy. BJS 2019; 106: 190-198.
Authors: J.‐M. Wu, T.‐C. Kuo, H.‐A. Chen, C.‐H. Wu, S.‐R. Lai, C.‐Y. Yang et al.
Clinical and experimental studies of intraperitoneal lipolysis and the development of clinically relevant pancreatic fistula after pancreatic surgery. BJS 2019; 106: 616-625.
Authors: Y. Uchida, T. Masui, K. Nakano, A. Yogo, A. Sato, K. Nagai et al.
Authors: T. M. Mackay, U. F. Wellner, L. B. van Rijssen, T. F. Stoop, O. R. Busch, B. Groot Koerkamp et al.
Multicentre propensity score‐matched study of laparoscopic versus open repeat liver resection for colorectal liver metastases. BJS 2019; 106: 783-789.
Authors: M. J. van der Poel, L. Barkhatov, D. Fuks, G. Berardi, F. Cipriani, A. Aljaiuossi et al.
Proposal for a new classification for perihilar cholangiocarcinoma based on tumour depth. BJS 2019; 106: 427-435.
Authors: K. Shinohara, T. Ebata, Y. Shimoyama, M. Nakaguro, T. Mizuno, K. Matsuo et al.
Systematic review of the quantity and quality of randomized clinical trials in pancreatic surgery. BJS 2019; 106: 23-31.
Authors: F. J. Hüttner, L. Capdeville, F. Pianka, A. Ulrich, T. Hackert, M. W. Büchler et al.