TY - JOUR
T1 - The effect of ursodiol on the efficacy and safety of extracorporeal shock-wave lithotripsy of gallstones
T2 - The dornier national biliary lithotripsy study
AU - Casarella, William
AU - Davis, R. Carter
AU - Steinberg, Harvey V.
AU - Torres, William E.
AU - Schoenfield, Leslie J.
AU - Berci, George
AU - lu, Shelly
AU - Marks, Jay W.
AU - Maher, James W.
AU - Summers, Robert W.
AU - Nahrwold, David L.
AU - Nemcek, Albert
AU - Johnson, A. Cedrick
AU - Jordan, Lee G.
AU - Maglinte, Dean
AU - Laufer, Igor
AU - Malet, Peter F.
AU - Malt, Ronald A.
AU - Reinhold, Randolph B.
AU - Rothschild, Janice G.
AU - Carnovale, Richard L.
AU - Chumley, Delbert
AU - Rosenthal, Arthur
AU - Gillenwater, Jay Y.
AU - Jones, R. Scott
AU - McCallum, Richard W.
AU - Pambianco, Daniel J.
AU - Schirmer, Bruce D.
AU - Caslowitz, Pam
AU - Kafonek, David R.
AU - Lillemoe, Keith D.
AU - Pitt, Henry A.
AU - Saba, George
PY - 1990/11/1
Y1 - 1990/11/1
N2 - In the treatment of gallstones with extracorporeal shock-wave lithotripsy, the bile acid ursodiol is administered to dissolve the gallstone fragments. We designed our study to determine the value of administering this agent. At 10 centers, 600 symptomatic patients with three or fewer radiolucent gallstones 5 to 30 mm in diameter, as visualized by oral cholecystography, were randomly assigned to receive ursodiol or placebo for six months, starting one week before lithotripsy. The stones were fragmented in 97 percent of all patients, and the fragments were ≤5 mm in diameter in 46.8 percent. On the basis of an intention-to-treat analysis of all 600 patients, 21 percent receiving ursodiol and 9 percent receiving placebo (P<0.0001) had gallbladders that were free of stones after six months. Among those with completely radiolucent solitary stones <20 mm in diameter, 35 percent of the patients receiving ursodiol and 18 percent of those receiving placebo (P<0.001) were free of stones after six months. Biliary pain, usually mild, occurred in 73 percent of all patients but in only 13 percent of those who were free of stones after three and six months (P<0.01). There were few adverse events. Only diarrhea occurred with a significantly different frequency in the two groups: 32.6 percent were affected in the ursodiol group, as compared with 24.7 percent in the placebo group (P<0.04). Severe biliary pain occurred in 1.5 percent of all patients, acute cholecystitis in 1.0 percent, and acute pancreatitis in 1.5 percent; endoscopic sphincterotomy was performed in 0.5 percent, and cholecystectomy in 2.5 percent. Extracorporeal shock-wave lithotripsy with ursodiol was more effective than lithotripsy alone for the treatment of symptomatic gallstones, and equally safe. Treatment was more effective for solitary than multiple stones, radiolucent than slightly calcified stones, and smaller than larger stones. (N Engl J Med 1990; 323: 1239–45.)
AB - In the treatment of gallstones with extracorporeal shock-wave lithotripsy, the bile acid ursodiol is administered to dissolve the gallstone fragments. We designed our study to determine the value of administering this agent. At 10 centers, 600 symptomatic patients with three or fewer radiolucent gallstones 5 to 30 mm in diameter, as visualized by oral cholecystography, were randomly assigned to receive ursodiol or placebo for six months, starting one week before lithotripsy. The stones were fragmented in 97 percent of all patients, and the fragments were ≤5 mm in diameter in 46.8 percent. On the basis of an intention-to-treat analysis of all 600 patients, 21 percent receiving ursodiol and 9 percent receiving placebo (P<0.0001) had gallbladders that were free of stones after six months. Among those with completely radiolucent solitary stones <20 mm in diameter, 35 percent of the patients receiving ursodiol and 18 percent of those receiving placebo (P<0.001) were free of stones after six months. Biliary pain, usually mild, occurred in 73 percent of all patients but in only 13 percent of those who were free of stones after three and six months (P<0.01). There were few adverse events. Only diarrhea occurred with a significantly different frequency in the two groups: 32.6 percent were affected in the ursodiol group, as compared with 24.7 percent in the placebo group (P<0.04). Severe biliary pain occurred in 1.5 percent of all patients, acute cholecystitis in 1.0 percent, and acute pancreatitis in 1.5 percent; endoscopic sphincterotomy was performed in 0.5 percent, and cholecystectomy in 2.5 percent. Extracorporeal shock-wave lithotripsy with ursodiol was more effective than lithotripsy alone for the treatment of symptomatic gallstones, and equally safe. Treatment was more effective for solitary than multiple stones, radiolucent than slightly calcified stones, and smaller than larger stones. (N Engl J Med 1990; 323: 1239–45.)
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U2 - 10.1056/NEJM199011013231804
DO - 10.1056/NEJM199011013231804
M3 - Article
C2 - 2215608
AN - SCOPUS:0025131059
SN - 0028-4793
VL - 323
SP - 1239
EP - 1245
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 18
ER -