Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study.
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Hagens Eliza R C, van Berge Henegouwen Mark I, van Sandick Johanna W, Cuesta Miguel A, van der Peet Donald L, Heisterkamp Joos, Nieuwenhuijzen Grard A P, Rosman Camiel, Scheepers Joris J G, Sosef Meindert N, van Hillegersberg Richard, Lagarde Sjoerd M, Nilsson Magnus, Räsänen Jari, Nafteux Philippe, Pattyn Piet, Hölscher Arnulf H, Schröder Wolfgang, Schneider Paul M, Mariette Christophe, Castoro Carlo, Bonavina Luigi, Rosati Riccardo, de Manzoni Giovanni, Mattioli Sandro, Garcia Josep Roig, Pera Manuel, Griffin Michael, Wilkerson Paul, Chaudry M Asif, Sgromo Bruno, Tucker Olga, Cheong Edward, Moorthy Krishna, Walsh Thomas N, Reynolds John, Tachimori Yuji, Inoue Haruhiro, Matsubara Hisahiro, Kosugi Shin-Ichi, Chen Haiquan, Law Simon Y K, Pramesh C S, Puntambekar Shailesh P, Murthy Sudish, Linden Philip, Hofstetter Wayne L, Kuppusamy Madhan K, Shen K Robert, Darling Gail E, Sabino Flávio D, Grimminger Peter P, Meijer Sybren L, Bergman Jacques J G H M, Hulshof Maarten C C M, van Laarhoven Hanneke W M, Mearadji Banafsche, Bennink Roel J, Annema Jouke T, Dijkgraaf Marcel G W, Gisbertz Suzanne S
Аннотация
METHODS: The TIGER study is an international observational cohort study with 50 participating centers. Patients with a resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in participating centers will be included. All lymph node stations will be excised and separately individually analyzed by pathological examination. The aim is to include 5000 patients. The primary endpoint is the distribution of lymph node metastases in esophageal and esophago-gastric junction carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and (disease free) survival.
DISCUSSION: The TIGER study will provide a roadmap of the location of lymph node metastases in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored treatment can be developed based on these results, such as the optimal radiation field and extent of lymphadenectomy based on the primary tumor characteristics.
TRIAL REGISTRATION: NCT03222895 , date of registration: July 19th, 2017.