Approximately 700,000 patients in the United States have their gallbladder removed every year. Last July, 59-year-old Cindy Robinson was one of them.
But unlike most other gallbladder surgery candidates, Robinson presented no evidence of gallstones. Her doctors couldn’t figure out why she was reporting such severe pain.
“Doctors couldn’t pinpoint anything,” she said. “They kept saying the tests were all inconclusive.”
But Robinson, who lives in Goose Creek, said the pain kept getting worse. She couldn’t eat. She lost 25 pounds.
“I had no energy. I could hardly lift my head up off the pillow,” she said. “I felt like I was dying.”
Finally, her doctor found a polyp inside her gallbladder and scheduled surgery at Trident Medical Center last year. After the operation, they found out her gallbladder was actually filled with polyps and thick, green sludge. Immediately, she said, she felt better. “It was amazing.”
Robinson counts herself lucky. “I really dodged a bullet,” she said.
But more than 10 percent of patients, particularly those like Robinson without gallstones, who have their gallbladder removed say the operation doesn’t make their pain go away.
Dr. Peter Cotton, a gastroenterologist at the Medical University of South Carolina, has designed a national study to determine which of these patients will most likely benefit from gallbladder surgery.
“I’m not here to say we should stop taking gallbladders out,” Cotton said. “I’m saying we need to understand a little bit better which patients are definitely going to benefit because there are risks involved.”
The gallbladder, part of the digestive system, serves as a reservoir for bile, a fluid produced by the liver that helps break down food.
“When you eat, (the gallbladder) is supposed to empty the bile into the intestines to help you digest the food,” Cotton explained.
Even so, the gallbladder, about the size of a standard salt shaker when it’s full, isn’t crucially important. And when cholesterol and other particles form hard pellets called gallstones inside the gallbladder, the only reliable way to improve the pain is to remove the organ altogether.
“It’s a very good operation for people who’ve got stones,” Cotton said.
But there are rare complications from the surgery.
“Surgeons may inadvertently cut the wrong thing and if they damage the bile duct, that can actually be a major problem. It can involve lots more surgeries, a lot more interventions, even some very rare fatalities,” Cotton said.
That’s why he wants to figure out who really needs surgery and who doesn’t. His study will target patients without gallstones who suffer from a “much more speculative situation” called “functional gallbladder disorder,” he said. “The pain sounds awfully like gallstones but all the tests are negative.”
Approximately 20 percent of gallbladder operations in the United States are performed to ease the pain associated with functional gallbladder disorder and they’re generally less successful than surgeries performed to treat gallstones, Cotton said.
He is applying for a $1.5 million, three-year grant from the National Institutes of Health to start his research at MUSC next year in collaboration with the Mayo Clinic. The study may then expand to a $10 million research project, which could include 10 sites across the country.
At first, his team will identify 10 patients with functional gallbladder disorder for a double-blind study. Five patients will undergo surgery to remove their gallbladder. The other five will think they’ve had their gallbladder removed, but really will have only had a “sham” operation.
Cotton wants to study differences between the groups to determine if surgery really improves their symptoms.
“The patient doesn’t know what’s happened to them and the people who are assessing their results don’t know either,” he explained.
Other studies have shown that some patients undergoing “sham” operations for various conditions say they feel better.
“Actually sorting out what is real and what is not is difficult,” Cotton said. “We want to increase the chances that people who get the surgery will be happy down the road.”
Reach Lauren Sausser at 937-5598.