Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study

Hagens ERC, van Berge Henegouwen MI, van Sandick JW, Cuesta MA, van der Peet DL, Heisterkamp J, Nieuwenhuijzen GAP, Rosman C, Scheepers JJG, Sosef MN, van Hillegersberg R, Lagarde SM, Nilsson M, Räsänen J, Nafteux P, Pattyn P, Hölscher AH, Schröder W, Schneider PM, Mariette C, Castoro C, Bonavina L, Rosati R, de Manzoni G, Mattioli S, Garcia JR, Pera M, Griffin M, Wilkerson P, Chaudry MA, Sgromo B, Tucker O, Cheong E, Moorthy K, Walsh TN, Reynolds J, Tachimori Y, Inoue H, Matsubara H, Kosugi SI, Chen H, Law SYK, Pramesh CS, Puntambekar SP, Murthy S, Linden P, Hofstetter WL, Kuppusamy MK, Shen KR, Darling GE, Sabino FD, Grimminger PP, Meijer SL, Bergman JJGHM, Hulshof MCCM, van Laarhoven HWM, Mearadji B, Bennink RJ, Annema JT, Dijkgraaf MGW, Gisbertz SS

Research output: Contribution to journalArticle

Abstract

BACKGROUND: An important parameter for survival in patients with esophageal carcinoma is lymph node status. The distribution of lymph node metastases depends on tumor characteristics such as tumor location, histology, invasion depth, and on neoadjuvant treatment. The exact distribution is unknown. Neoadjuvant treatment and surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy has not been reached. The aim of this study is to determine the distribution of lymph node metastases in patients with resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed. This can be the foundation for a uniform worldwide staging system and establishment of the optimal surgical strategy for esophageal cancer patients.

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.

Original languageEnglish
Pages (from-to)662
JournalBMC Cancer
Volume19
Issue number1
DOIs
Publication statusPublished - Jul 4 2019

Keywords

  • Adenocarcinoma/surgery
  • Carcinoma, Squamous Cell/surgery
  • Disease-Free Survival
  • Esophageal Neoplasms/surgery
  • Esophagectomy
  • Esophagogastric Junction/pathology
  • Follow-Up Studies
  • Humans
  • Lymph Node Excision
  • Lymph Nodes/pathology
  • Lymphatic Metastasis/diagnosis
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Prognosis

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  • Cite this

    Hagens ERC, van Berge Henegouwen MI, van Sandick JW, Cuesta MA, van der Peet DL, Heisterkamp J, Nieuwenhuijzen GAP, Rosman C, Scheepers JJG, Sosef MN, van Hillegersberg R, Lagarde SM, Nilsson M, Räsänen J, Nafteux P, Pattyn P, Hölscher AH, Schröder W, Schneider PM, Mariette C, Castoro C, Bonavina L, Rosati R, de Manzoni G, Mattioli S, Garcia JR, Pera M, Griffin M, Wilkerson P, Chaudry MA, Sgromo B, Tucker O, Cheong E, Moorthy K, Walsh TN, Reynolds J, Tachimori Y, Inoue H, Matsubara H, Kosugi SI, Chen H, Law SYK, Pramesh CS, Puntambekar SP, Murthy S, Linden P, Hofstetter WL, Kuppusamy MK, Shen KR, Darling GE, Sabino FD, Grimminger PP, Meijer SL, Bergman JJGHM, Hulshof MCCM, van Laarhoven HWM, Mearadji B, Bennink RJ, Annema JT, Dijkgraaf MGW, Gisbertz SS (2019). Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study. BMC Cancer, 19(1), 662. https://doi.org/10.1186/s12885-019-5761-7