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

Abstract

Background 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. Methods/design 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT03713749 . Registered on 22 October 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3441-1) contains supplementary material, which is available to authorized users.

Recent advances in minimally invasive esophagectomy for squamous esophageal cancer

“…47 A prospective multicenter randomized controlled trial is currently ongoing and the result of the trial could provide more solid evidence on the benefit of RAMIE as compared with conventional MIE. 48 To reduce pulmonary complications from transthoracic esophagectomy, transcervical mediastinal esophagectomy has been explored. 49 Through an extended cervical incision, esophageal and lymphatic dissection can be performed at the superior mediastinum down to level of the aortic arch using a single-port technique.…”

Robotic esophagectomy: how I do it?

“…When compared to open or traditional MIE, locoregional recurrence rates following RAMIE have been reported to be comparable or lower [5,23] . Robotic surgical platforms may offer advantages in dissection along the RLN in the apex of the chest, performed with the patient in either the prone or lateral decubitus position [24,25] . A number of publications have also confirmed the lower incidence of RLN neuropraxia and vocal cord paralysis with RAMIE when compared to traditional MIE [26,27] .…”

“…The REVATE trial, a two-center, open-label RCT of esophageal SCC, will compare lymph node dissection along the RLN during RAMIE vs. MIE [25] . The two institutions participating in this RCT are from China and Taiwan, where SCC is more prominent than esophageal adenocarcinoma, favoring upper or middle esophageal tumors where dissection of lymph nodes around the RLNs is critical.…”

Initial introduction of robot-assisted, minimally invasive esophagectomy using the microanatomy-based concept in the upper mediastinum

“…There have been several reports on its advantages in esophagectomy and reconstruction such as by Mckeown and Ivor Lewis due to its 10 × magnified three-dimensional (3D) stereoscopic vision system, wrist-like joint system, and shake reduction system [ 18 – 21 ]. However, reports of its usefulness in UMLND have been rare, and the first worldwide, prospective, randomized, controlled study has just started [ 22 ]. The progress in the development of the robot system has also been remarkable.…”