New benchmark standards reveal high level of gallbladder cancer surgery complications
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Key takeaways:
- Rates of postoperative complications within 90 days remain high among patients who undergo gallbladder cancer surgery.
- Patients treated at benchmark surgical programs had significantly longer OS.
One-fifth of patients who underwent gallbladder cancer surgery at top-performing centers experienced related complications within 90 days, according to results of a retrospective study published in Annals of Surgical Oncology.
The study established benchmark values that evaluate the quality of a center’s gallbladder cancer surgery program with the aim of improving outcomes and reducing mortality.
“Defining benchmark values for gallbladder cancer surgery will create a reference that institutions can use to assess their surgical performance, improve surgical outcomes, and help move centers that currently perform lower-quality gallbladder cancer surgery toward performing higher-quality surgery,” Eduardo A. Vega, MD, assistant professor of surgery at Boston University School of Medicine,” told Healio. “Having benchmark values will allow patients and clinicians to differentiate outcomes based on performance instead of brand or reputation, which may make smaller local centers more attractive candidates if they demonstrate adequate performance against the benchmark standards.”
Background
A previous study of U.S.-based patients showed that less than 10% of those who underwent surgical resection for gallbladder cancer received what researchers determined to be a high-quality procedure according to current guidelines, Vega said.
Additionally, no benchmark standards existed to help determine what constituted a “high-quality” surgical procedure, he added.
“Gallbladder cancer is the most common biliary tract cancer in the United States, with no newly developed treatments in the last 20 years,” Vega said. “Benchmarking has been used for a long time in economics and has recently been adapted for medicine, but we have been unable to find any evidence of previous attempts to provide such an analysis for gallbladder cancer surgery.”
Methodology
Researchers from Boston University Chobanian & Avedisian School of Medicine and The University of Texas MD Anderson Cancer Center conducted a retrospective analysis to determine benchmark values for gallbladder cancer surgery using an international patient population.
The analysis included 906 consecutive adults with gallbladder cancer who underwent surgical resection with curative intent between 2000 and 2021.
Investigators chose 245 individuals (median age, 64 years; interquartile range, 57-70; 71% women) with no significant comorbidities and without the need for vascular and/or bile duct reconstruction who underwent surgery at high-volume centers as the benchmark group.
Parameters used to establish benchmark values included the number of lymph nodes retrieved, estimated blood loss, perioperative blood transfusion rate, R1 surgical margins, length of postoperative hospital stay, operative time, complications, and grade IIIa or higher Clavien-Dindo complications.
Key findings
The analysis established the following benchmark values for gallbladder cancer surgery:
four or more lymph nodes retrieved; estimated intraoperative blood loss of350 mL or less; perioperative blood transfusion rate 13% or less; operative time of 332 minutes or less; length of hospital stay of 8 days or less; R1 margin rate of 7% or less; complication rate of 22% or less; and rate of grade IIIa or greater complications of 11% or less.
Researchers reported significantly longer OS in the benchmark group compared with the nonbenchmark group (HR = 0.78; 95% CI, 0.62-0.98) but no significant difference between the groups with respect to recurrence-free survival (HR = 0.95; 95% CI, 0.76-1.22).
Clinical implications
“These results were surprising,” Vega told Healio. “Although gallbladder cancer is believed to be a low-morbidity surgery, even highly experienced centers had a level of complications similar to those seen with more complex procedures.”
The results suggest that conducting a high volume of procedures is not a surrogate for performing high-quality gallbladder cancer surgery, according to Vega.
“At some point, we need to move on from volume to evidence and data to assess quality,” he said.
For more information:
Eduardo A. Vega, MD, can be reached at Department of Surgery, Saint Elizabeth’s Medical Center, Boston University Medical School, 11 Nevins St., Suite 201, Boston, MA 02135; email: eavega@bu.edu.
Perspective
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Kanika Nair, MD
Gallbladder cancer is a rare disease, and the only chance at cure is with surgical resection. This study retrospectively evaluated surgical benchmarks from 906 patients with curative-intent surgery for gallbladder cancer at high-volume centers across four continents to have a standard of care and assure quality. Results showed a correlation between these benchmarks and OS. Interestingly, RFS was not statistically significant, even though the non-benchmark group had more patients with advanced disease. However, there was a statistically significant difference in the surgical techniques used between the two groups, which may account for this.Establishing benchmarks for low-risk patients undergoing curative-intent surgery for a challenging disease is a good idea to ensure quality, especially when there is significant variation even among high-volume centers internationally, and this study shows it may even correlate to clinical outcomes. Prospective studies and validation of these benchmarks will be important before they can be used in clinical practice. However, this will not replace the need for patients to be evaluated at high-volume and experienced centers in a disease in which nearly three-fourths of the population is high-risk.
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