Clinical Trials

ROBOT TRIAL

Pieter C van der Sluis, Sylvia van der Horst, Anne M May, Carlo Schippers, Lodewijk AA Brosens, Hans CA Joore, Christiaan C Kroese 5, Nadia Haj Mohammad, Stella Mook, Frank P Vleggaar, Inne HM Borel Rinkes, Jelle P Ruurda, Richard van Hillegersberg

Background: The standard curative treatment for patients with esophageal cancer is perioperative chemotherapy or preoperative chemoradiotherapy followed by open transthoracic esophagectomy (OTE). Robot-assisted minimally invasive thoracolaparoscopic esophagectomy (RAMIE) may reduce complications.
Methods/design: A single-center randomized controlled trial was conducted, assigning 112 patients with resectable intrathoracic esophageal cancer to either RAMIE or OTE. The primary endpoint was the occurrence of overall surgery-related postoperative complications (modified Clavien-Dindo classification grade 2-5).
Results: Overall surgery-related postoperative complications occurred less frequently after RAMIE (59%) compared to OTE (80%) [risk ratio with RAMIE (RR) 0.74; 95% confidence interval (CI), 0.57-0.96; P = 0.02]. RAMIE resulted in less median blood loss (400 vs 568 mL, P <0.001), a lower percentage of pulmonary complications (RR 0.54; 95% CI, 0.34-0.85; P = 0.005) and cardiac complications (RR 0.47; 95% CI, 0.27-0.83; P = 0.006) and lower mean postoperative pain (visual analog scale, 1.86 vs 2.62; P < 0.001) compared to OTE. Functional recovery at postoperative day 14 was better in the RAMIE group [RR 1.48 (95% CI, 1.03-2.13; P = 0.038)] with better quality of life score at discharge [mean difference quality of life score 13.4 (2.0-24.7, p = 0.02)] and 6 weeks postdischarge [mean difference 11.1 quality of life score (1.0-21.1; P = 0.03)]. Short- and long-term oncological outcomes were comparable at a medium follow-up of 40 months.
Discussion: RAMIE resulted in a lower percentage of overall surgery-related and cardiopulmonary complications with lower postoperative pain, better short-term quality of life, and a better short-term postoperative functional recovery compared to OTE. Oncological outcomes were comparable and in concordance with the highest standards nowadays.

ClinicalTrials.gov, NCT01544790
Full text available in the Annals of Surgery.

REVATE TRIAL

Yin-Kai Chao, Zhi-Gang Li, Yu-Wen Wen, Dae-Joon Kim, Seong-Yong Park, Yu-Ling Chang, Pieter C. van der Sluis, Jelle P. Ruurda and Richard van Hillegersberg

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.

ClinicalTrials.gov, NCT03713749. Registered on 22 October 2018.
Full study protocol accessible via Trials.