NC West Virginia News

Although surgery is a common treatment for patients diagnosed with biliary dyskinesia, or functional gallbladder disorder, a West Virginia University medical researcher is questioning why the practice has become so widespread when little clinical research is available.

Biliary dyskinesia is a gallbladder disorder in which patients don’t have gallstones yet experience similar pain in the upper right quadrant of the abdomen, usually following a fatty meal, that lasts 30 minutes or longer and is significant enough to disrupt normal activities. In the United States, it’s the most common indicator for gallbladder removal — cholecystectomy — in children and accounts for between 10% and 20% of the surgeries in adults.

“When you see the number of cases of surgery increasing, you just want to make sure that it’s being done for the right indications and that the patients are benefiting, but that’s where there were so many gaps in the data,” said Dr. Bryan Richmond, chair and professor at the WVU School of Medicine Charleston Campus Department of Surgery. “The practice of cholecystectomy for this condition is not embraced in other countries.”

While doctors don’t know what causes patients to develop the disorder, they know it results when the gallbladder doesn’t contract as it should to release bile through the ducts.

To properly diagnose functional gallbladder disorder and select which patients would best benefit from the surgery, Richmond said a combination of factors must come together: biliary pain, absence of gallstones and a low gallbladder ejection fraction — how much bile the gallbladder releases when it contracts.

To measure the ejection fraction, clinicians conduct what’s called a cholecystokinin-cholescintigraphy (CCK-HIDA) scan. However, Richmond said that test is sometimes misused.

“What makes it tricky is the scan itself doesn’t predict disease because values considered normal versus abnormal are calculated on normal healthy subjects, not patients with pain,” he said. “It has to be considered in context with patient symptoms—the combination of classic biliary symptoms with supporting findings on your scan to suggest surgery.”

Richmond’s invited manuscript published in JAMA discusses both supporting and lacking evidence for prevalence of surgery and suggests need for future studies. The publication’s editors asked Richmond to write after hearing his presentation at American College of Surgeons Clinical Congress.

He cites a 1991 study focused on whether patients benefitted from surgery and a 2016 randomized control trial he conducted with colleagues to refine research. Both found that patients with classic gallbladder pain symptoms, no gallstones and low ejection fraction were most likely to experience successful results from surgery. Still, neither study provides convincing evidence warranting increasing operations.

“The 1991 study had fewer than 30 patients—not enough to establish such dramatic change in practice,” Richmond said. “Our trial published in Journal of American College of Surgeons was still very small. At end day we don’t have large amounts data supporting practice.”

Richmond believes additional research with larger participant groups is needed ensuring surgery as best option based on symptom combination and ejection fraction scan results. He expects findings would validate 1991 and 2016 studies.

“My next goal would be obtaining funding for larger multicenter trial getting enough numbers standardizing inclusion criteria extended follow-up determining success versus failure,” he said. “I think we can show well-selected patients receive durable symptom relief from cholecystectomy; if departing from classic symptoms less likely success.”

Currently no treatment exists for functional gallbladder disorder beyond pain medications avoiding trigger foods. Until further research occurs Richmond advises physicians remain vigilant deciding on surgeries.

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