ROBOT-ASSISTED VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLONIC LESIONS: A RANDOMIZED, CONTROLLED, BOVINE COLON STUDY

BACKGROUND:
Endoscopic submucosal dissection (ESD) is becoming the preferred method for the management of early gastrointestinal (GI) malignancies. Although ESD offers a minimally invasive way to achieve en bloc resection, it is technically difficult, time consuming, and has a relatively high adverse event risk with variability depending on expertise. Given the promising, yet challenging nature of ESD, a novel, flexible, endoscopic robot has been developed (EndoQuest™ Robotics, Houston, TX) (Image 1). This is the first fully robotic endoluminal platform. It includes a robotic overtube, endoscope, and a range of exchangeable, flexible instruments, all controlled via a separate physician console. Our aim was to evaluate the efficacy, viability, and safety of robot-assisted vs conventional ESD performed by endoscopists with no prior ESD experience.

METHODS:
We conducted a randomized, controlled study comparing conventional ESD to a novel, robot-assisted ESD platform utilizing an ex-vivo bovine colon model. Ten endoscopists with similar endoscopic experience ranging from 2 to 4 years, and with no prior ESD or robotic experience, were randomized into two groups. Group 1 first performed one conventional ESD (Image 2) then one robot-assisted ESD, while Group 2 started with robot-assisted and then conventional ESD. All participants underwent a standardized teaching and practice session on both conventional and robotic-assisted ESD. A standard, circular, 2-cm lesion was made and placed at the 6 o’clock position for each procedure. The primary outcome was completion of en bloc resection. Secondary outcomes included procedure time, perforation rate, muscle injury rate, and National Aeronautical and Space Administration Task Load Index (NASA-TLX), a validated, quantitative survey of physical and mental workload.

RESULTS:
Ten endoscopists each performed 2 ESDs (one conventional and one robot-assisted) for a total of 20 procedures. Complete en bloc resection was successful in 40% of conventional and 100% of robot-assisted ESDs (P = 0.011). Mean procedure time was lower for robot-assisted procedures (32.3 vs 85.1 min; P < 0.001). Complications including muscle injury (40% vs 90%; P = 0.018) and perforations (0% vs 30%; P = 0.065) were also lower with robot-assisted procedures. NASA-TLX scores showed more physical and mental workload when endoscopists performed conventional ESD, 109.5, versus robot-assisted ESD, 54.1, (P < 0.001).

CONCLUSIONS:
In our study, robot-assisted ESD was more effective, faster, safer, and easier than conventional ESD among gastroenterologists without prior ESD experience. These findings suggest that robot-assisted ESD could help facilitate wider adoption of the technique beyond highly trained endoscopists. Further clinical study is now warranted.