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Robotic-assisted Esophagectomy vs Video-Assisted Thoracoscopic Esophagectomy (REVATE): study protocol for a randomized controlled trial

Authors
  • Chao, Yin-Kai1
  • Li, Zhi-Gang2
  • Wen, Yu-Wen3
  • Kim, Dae-Joon4
  • Park, Seong-Yong4
  • Chang, Yu-Ling5
  • van der Sluis, Pieter C.6
  • Ruurda, Jelle P.6
  • van Hillegersberg, Richard6
  • 1 Chang Gung University, Division of Thoracic Surgery, Chang Gung Memorial Hospital-Linko, Taoyuan, Taiwan , Taoyuan (Taiwan)
  • 2 Division of Thoracic Surgery Shanghai Chest Hospital, Shanghai, China , Shanghai (China)
  • 3 Clinical Informatics and Medical Statistics Research Center Chang Gung University, Taoyuan, Taiwan , Taoyuan (Taiwan)
  • 4 Yonsei University College of Medicine, Department of Thoracic and Cardiovascular Surgery, Seoul, Republic of Korea , Seoul (South Korea)
  • 5 Chang Gung University, School of Nursing, Taoyuan, Taiwan , Taoyuan (Taiwan)
  • 6 University Medical Center Utrecht, Department of Surgery, Utrecht, the Netherlands , Utrecht (Netherlands)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Jun 10, 2019
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s13063-019-3441-1
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundRadical lymph node dissection (LND) along the left recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question of whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.Methods/designWe will conduct a multicenter, open-label, randomized controlled trial (Robotic-assisted Esophagectomy vs Video-Assisted Thoracoscopic Esophagectomy (REVATE)) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as: failure to remove lymph nodes along the left RLN (i.e., no identifiable nodes on pathology reports); or occurrence of permanent (duration > 6 months) left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30-day and 90-day mortality, quality of life, and oncological outcomes.DiscussionThe REVATE study provides an opportunity to explore whether RE could facilitate LND along the left RLN—a complex surgical procedure that, as of now and with the use of VATE, remains difficult to perform and associated with a significant burden of morbidity.Trial registrationClinicalTrials.gov, NCT03713749. Registered on 22 October 2018.

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