Study finds duct procedure does not help certain patients
May 28, 2014
Endoscopic procedure does not reduce disability due to pain following gallbladder removal
CHARLESTON, SC – In certain patients with abdominal pain after gallbladder removal (cholecystectomy), undergoing an endoscopic procedure involving the bile and pancreatic ducts did not result in fewer days with disability due to pain, compared to a placebo treatment, according to a study in the May 28 issue of JAMA.
More than 700,000 patients undergo gallbladder removal each year in the United States, and at least 10 percent report continued pain post-surgery. Most of these patients have no significant abnormalities on imaging or laboratory testing, and the cause of pain remains uncertain. Many of these patients undergo endoscopic retrograde cholangiopancreatography (ERCP; the use of an endoscope to inspect the pancreatic duct and common bile duct) in the hope of finding small stones or other pathology or in an effort to address suspected sphincter of Oddi (a muscle at the juncture of the bile and pancreatic ducts and the small intestine that controls the flow of digestive juices) dysfunction. Of these patients, some undergo biliary or pancreatic sphincterotomy (surgical incision of a muscle that contracts to close an opening) or both. The value of this endoscopic intervention is unproven and the risks are substantial. Procedure-related pancreatitis rates are 10 to 15 percent, and perforations may occur. Many patients have prolonged and expensive hospital stays, and some die, according to background information in the article.
“These findings do not support the use of ERCP and sphincterotomy for these patients,” said Peter B. Cotton, M.D., MUSC Gastroenterology and Hepatology professor and study author. “The finding that endoscopic sphincterotomy is not an effective treatment has major implications for clinical practice because it applies to many thousands of patients.”
Cotton and his colleagues randomly assigned patients with pain after gallbladder removal to receive a sphincterotomy or placebo therapy after ERCP. When they revisited the patients’ pain scores during scheduled intervals, researchers noted that for a significant number of patients pain scores did not improve, and were elevated in some cases.
No clinical subgroups appeared to benefit from sphincterotomy more than others. Pancreatitis occurred in 11 percent of patients after primary sphincterotomies and in 15 percent of patients in the placebo group.
More information is available at http://media.jamanetwork.com/
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