New benchmark standards reveal high level of complications in gallbladder cancer surgery

Key learning points:

• The rate of postoperative complications within 90 days remains high in patients undergoing gallbladder cancer surgery.
• Patients treated according to standard surgical programs had a significantly longer OS.

One-fifth of patients undergoing 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 centers that are currently performing lower quality gallbladder cancer surgery move to performing higher quality surgery,” Eduardo A. Vega, MD, assistant professor of surgery at Boston University School of Medicine,” Healio said. “Having benchmark values ​​allows patients and clinicians to differentiate outcomes based on performance rather than brand or reputation, which can make smaller local centers more attractive if they perform well against 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 a high-quality procedure according to current guidelines, according to the researchers, Vega said.

In addition, no benchmark standards existed to help determine what constituted a “high quality” surgical procedure, he added.

“Gallbladder cancer is the most common bile duct cancer in the United States, with no newly developed treatments in the past 20 years,” Vega said. “Benchmarking has been used for a long time in economics and has recently been adapted for medicine, but we have not been able 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.

Researchers selected 245 subjects (median age, 64 years; interquartile range, 57-70; 71% female) without significant comorbidities and without the need for vascular and/or biliary reconstruction who underwent surgery at high volume centers as a benchmark group.

Parameters used to establish benchmark values ​​included number of lymph nodes retrieved, estimated blood loss, perioperative blood transfusion rate, R1 surgical margins, length of postoperative hospital stay, operative time, complications, and Clavien-Dindo grade IIIa or greater complications.

Main findings

The analysis established the following benchmark values ​​for gallbladder cancer surgery:

four or more lymph nodes removed; estimated intraoperative blood loss of 350 ml or less; perioperative blood transfusion rate 13% or less; operating time of 332 minutes or less; length of hospital stay of 8 days or less; R1 margin of 7% or less; complications of 22% or less; and the complication rate of grade IIIa or higher of 11% or less.

Investigators reported significantly longer OS in the benchmark group compared to the non-benchmark group (HR = 0.78; 95% CI, 0.62-0.98) but no significant between-group difference in recurrence-free survival (HR = 0.95, 95% CI, 0.76-1.22).

Clinical Implications

“These results were surprising,” Vega told Healio. “While gallbladder cancer is considered a low-morbidity surgery, even highly experienced centers had a level of complications comparable to those seen in more complex procedures.”

The results suggest that performing a large number of procedures is not a surrogate for performing high-quality gallbladder cancer surgery, Vega said.

“At some point we have to move from volume to evidence and data to assess quality,” he said.

For more information:

Eduardo A. Vega, MD, can be reached at the Department of Surgery, Saint Elizabeth’s Medical Center, Boston University Medical School, 11 Nevins St., Suite 201, Boston, MA 02135; email: eavega@bu.edu.