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

• Published in: Current controlled trials in cardiovascular medicine Vol. 20; no. 1; p. 346
• Main Authors: Chao, Yin-Kai, Li, Zhi-Gang, Wen, Yu-Wen, Kim, Dae-Joon, Park, Seong-Yong, Chang, Yu-Ling, van der Sluis, Pieter C, Ruurda, Jelle P, van Hillegersberg, Richard
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 10.06.2019; BioMed Central; BMC
• Subjects: Analysis; Cancer; Cancer research; Carcinoma; Care and treatment; Clinical trials; Comparative analysis; Data collection; Digestive system surgery; Esophageal cancer; Esophageal Neoplasms - surgery; Esophageal Squamous Cell Carcinoma - surgery; Esophagectomy - methods; Hospital Mortality; Humans; Labels; Lymph node dissection; Lymph Node Excision - methods; Lymphatic system; Medical care quality; Metastasis; Morbidity; Mortality; Multicenter Studies as Topic; Outcome Assessment, Health Care; Quality of Life; Randomized Controlled Trials as Topic; Recurrent laryngeal nerve; Risk factors; Robotic esophagectomy; Robotic surgery; Robotic Surgical Procedures - methods; Robotics; Robots; Squamous cell carcinoma; Study Protocol; Thoracic surgery; Thoracic Surgery, Video-Assisted - methods; Thoracoscopic esophagectomy; Japan; Robotic esophagectomy; Lymph node dissection; Thoracoscopic esophagectomy; Esophageal cancer; Recurrent laryngeal nerve
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3441-1

Radical 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. We 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. The 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. ClinicalTrials.gov, NCT03713749 . Registered on 22 October 2018.