Clinical trial NCT00042549: Lithotripsy for the Treatment of Gallstones
Official title: Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cholelithiasis
Keywords: Gallstones
Gallstone
Biliary stones
Gallbladder stones
Gallbladder
Lithotripsy
Cholelithiasis
ESWL
Shock wave
Shock waves
shockwaves
shockwave
Lead sponsor: Medstone International
Sponsor class: INDUSTRY
First posted: 2002-08-05
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: * 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: Virgina Commonwealth University
state: Virginia
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Atilla Ertan, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.