Lithotripsy for the Treatment of Gallstones

Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00042549
• Other study ID #: GS-PA-001
• Status: Terminated
• Phase: Phase 4
• First received: July 31, 2002
• Last updated: June 23, 2005
• Start date: May 2002

Study information

• Verified date: June 2003
• Source: Medstone International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 184
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Device:
• Extracorporeal Shock Wave Lithotripsy

Drug:
• ursodiol

Locations

Country	Name	City	State
United States	The Methodist Hospital	Houston	Texas
United States	Virgina Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Medstone International

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Ertan A. Treatment of gallstones by extracorporeal shock wave lithotripsy. Am J Gastroenterol. 2002 Apr;97(4):831-2. Review. — View 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. — View 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. — View Citation

Vanderpool D, Jones RC, O'Leary JP, Hamilton JK. Biliary lithotripsy. Am J Surg. 1989 Sep;158(3):194-7. Review. — View Citation

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