Rates of bile duct injury a year after gallbladder removal surgery were lower with laparoscopic procedures than robotic-assisted ones, a retrospective study of Medicare beneficiaries found.
Robotic-assisted cholecystectomy was tied to a 0.7% rate of bile duct injury that required definitive surgical reconstruction within 1 year compared with a 0.2% rate for laparoscopic cholecystectomy (relative risk 3.16, 95% CI 2.57-3.75), reported Stanley Kalata, MD, MS, of the University of Michigan in Ann Arbor, and colleagues.
"This cohort study's finding of significantly higher rates of bile duct injury with robotic-assisted cholecystectomy compared with laparoscopic cholecystectomy suggests that the utility of robotic-assisted cholecystectomy should be reconsidered, given the existence of an already minimally invasive, predictably safe laparoscopic approach," Kalata and co-authors wrote in JAMA Surgery.
"With this new technology -- the robot -- while it has theoretical benefit in terms of being a fancier technology, we don't have any data to say that it necessarily is better," Kalata told MedPage Today. "It's not clear if the juice is worth the squeeze here for taking out a gallbladder."
Robotic-assisted procedures have become more common overall in recent years. This trend may expose patients to harm as surgeons learn the new approach, the researchers noted. Studies suggesting inferior oncologic outcomes with robotic-assisted surgery for breast cancer have prompted the FDA to issue a public safety notice, they added.
Robotic-assisted surgery may or may not be a good fit for cholecystectomies, Kalata observed.
"Right at this moment ... is when the inflection point will come of whether or not this technology will be taken up for gallbladder surgery or not," he said. But "the one complication we worry about -- the real life-changing, devastating complication you could have after gallbladder surgery, which happens very rarely -- is this bile duct injury that we found."
The pattern of bile duct injury was consistent in sensitivity analyses and "was mitigated in hospitals with a higher volume of robotic procedures, suggesting a learning-curve effect rather than selection of more difficult cases," noted Liane Feldman, MD, of McGill University in Montreal, and L. Michael Brunt, MD, of the Washington University School of Medicine in St. Louis, in an invited commentary.
"This important observation should be considered in light of some limitations in the current study," which included an older Medicare population with high rates of non-elective and open surgery, the editorialists pointed out.
"Regardless of approach, this study highlights the need to adhere to principles of safe cholecystectomy," Feldman and Brunt said, including accurate imaging of the biliary tree, confirming anatomy before clipping and cutting, and applying bail-out maneuvers when the hepatocystic triangle is too inflamed or fibrotic.
Kalata and colleagues used Medicare Provider Analysis and Review claims for 1,026,088 patients who had cholecystectomy from 2010 through 2019. Patients in Medicare Advantage plans or who had gallbladder, bile duct, or liver cancers were excluded.
The primary outcome was the rate of bile duct injury requiring definitive surgical reconstruction within 1 year after cholecystectomy, measured by ICD-9 or ICD-10 codes. Secondary outcomes were biliary interventions and overall incidence of postoperative complications.
About half (53.3%) of the study population was female and 82.2% were white. Mean age was 72.
Robotic-assisted cholecystectomy increased from 0.1% of patients in 2010 to 5.2% in 2019. Laparoscopic cholecystectomies increased from 75.4% of patients to 77.8% in the same period, while open cholecystectomy decreased from 24.4% to 17%.
Rates of bile duct injury decreased over time for each surgical technique, from 0.3% to 0.1% of laparoscopic and from 0.7% to 0.5% of robotic-assisted cholecystectomies in 2010 and 2019, respectively.
Robotic-assisted versus laparoscopic cholecystectomy was associated with higher rates of biliary interventions (7.4% vs 6.0%, respectively) and serious complications (9.3% vs 8.6%). There was no significant difference between 30-day overall complication rates between the two procedures (20.5% vs 20.6%, respectively).
Study limitations included the potential for inaccurate coding, unmeasured variables, procedural factors (like severity of gallbladder inflammation), and intraoperative conversions from one procedure to another, Kalata and co-authors acknowledged.
The study could not determine whether the robotic platform increased the number of patients eligible for a minimally invasive operation, the researchers added. Medicare data may not be generalizable to other populations.
Study funding came from the National Institute of Diabetes and Digestive and Kidney Diseases.
Kalata reported grants from the Agency for Healthcare Research and Quality and the Frederick A. Coller Surgical Society. A co-author reported relationships with ArborMetrix.
The editorialists had no financial disclosures.
Source Reference: Kalata S, et al "Comparative safety of robotic-assisted vs laparoscopic cholecystectomy" JAMA Surg 2023; DOI: 10.1001/jamasurg.2023.4389.
Source Reference: Feldman LS, Brunt LM "New technology and bile duct injuries" JAMA Surg 2023; DOI: 10.1001/jamasurg.2023.4404.