Clinical Question: What is the natural history of patients with uncomplicated, symptomatic gallstone disease?

Setting: Outpatient (specialty)

Study Design: Randomized controlled trial (nonblinded)

Synopsis: Does every patient with symptomatic gallstones need surgery? Vetrhus and others identified nonpregnant patients 18 to 80 years of age with symptoms of gallbladder disease or gallstones on ultrasonography, and no other explanation for their symptoms. Patients with minor or infrequent symptoms were excluded. Of the 293 patients asked to join the study, 137 agreed to be randomized to surgery or observation. The study was done well; initial allocation to groups was appropriately concealed from the enrolling investigator, patients in the groups were similar at baseline, and analysis was by intention-to-treat. The investigators and patients were not blinded. Those in the observation group were not given any special instructions other than to avoid foods that provoked their symptoms. Only one patient dropped out of the study; the remainder were followed for a median of 5.6 years. About one half of the patients in the observation group eventually had their gallbladders removed (35 of 69), compared with 88 percent of the patients (60 of 68) in the surgery group. The survival curve shows that the cumulative risk of having a cholecystectomy levels off after three to four years. Complications were rare: in the observation group, two patients had common bile duct stones and one had acute cholecystitis, while one patient in the surgery group had acute pancreatitis.

Bottom Line: Patients with uncomplicated, symptomatic gallstones have a 50:50 chance of avoiding surgery if they modify their eating habits. Thus, watchful waiting is a reasonable option for motivated patients. (Level of Evidence: 1b)