Lithotripsy for the Treatment of Gallstones

Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones

The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.

This study is a randomized, single-masked controlled trial in which the combination therapy of lithotripsy and the bile acid drug Actigall is compared to monotherapy with only Actigall. The primary objectives are, 1) To determine whether the use of the Medstone STS Lithotripter system in combination with the orally administered drug Actigall is more effective (as measured by percentages of stone free patients 6 months after randomization) in reducing single non-calcified radiolucent gallstones (from 4 to 20mm in diameter) than use of Actigall alone, and 2) To demonstrate that use of the Medstone lithotripsy system is safe (as measured by incidence of adverse events) for the intended purpose, when operated according to its labeling.

Gallstones, Gallstone, Biliary stones, Gallbladder stones, Gallbladder, Lithotripsy, Cholelithiasis, ESWL, Shock wave, Shock waves, shockwaves, shockwave

History of biliary pain Evidence of a single noncalcified, radiolucent gallstone between 4 and 20 mm (inclusive) diameter HIDA scan demonstrating patency of cystic bile duct No cardiac pacemaker No allergy to radioopaque dye, iodine, bile acids No spontaneous or iatrogenic bleeding disorder No current or prior bile duct obstruction, cholangitis, pancreatitis, or cholecystitis Not pregnant

Ertan A. Treatment of gallstones by extracorporeal shock wave lithotripsy. Am J Gastroenterol. 2002 Apr;97(4):831-2. doi: 10.1111/j.1572-0241.2002.05738.x. No abstract available.

Ertan A, Hernandez RE, Campeau RJ, Geshner JR, Litwin MS. Extracorporeal shock-wave lithotripsy and ursodiol versus ursodiol alone in the treatment of gallstones. Gastroenterology. 1992 Jul;103(1):311-6. doi: 10.1016/0016-5085(92)91128-q.

Vanderpool D, Jones RC, O'Leary JP, Hamilton JK. Biliary lithotripsy. Am J Surg. 1989 Sep;158(3):194-7. doi: 10.1016/0002-9610(89)90251-1.

Sackmann M, Pauletzki J, Sauerbruch T, Holl J, Schelling G, Paumgartner G. The Munich Gallbladder Lithotripsy Study. Results of the first 5 years with 711 patients. Ann Intern Med. 1991 Feb 15;114(4):290-6. doi: 10.7326/0003-4819-114-4-290.

Pelletier G, Raymond JM, Capdeville R, Mosnier H, Caroli-Bosc FX. Gallstone recurrence after successful lithotripsy. J Hepatol. 1995 Oct;23(4):420-3. doi: 10.1016/0168-8278(95)80200-2.

UpToDate is a practical clinical information service (always current). It is written by a recognized faculty of experts who each address a specific clinical issue. They synthesize the latest evidence and best practices.