Status:
COMPLETED
Randomized Trial of ERCP Then Laparoscopic Cholecystectomy vs. Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration in Patients With Likely Choledocholithiasis
Lead Sponsor:
University of California, San Francisco
Conditions:
Choleclithiasis
Common Bile Duct Stones
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to ei...
Detailed Description
Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to ei...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Classic biliary-type pain
- Ultrasonographic demonstration of cholecystolithiasis
- Platelet count \> 100,000 per mm³ and prothrombin time \< 3 seconds of control
- American Society of Anesthesiology (ASA) risk grade I or II:
- Common bile duct diameter greater than 6 mm by ultrasound or computed tomography (CT) scan
- Intrahepatic duct dilation as determined by ultrasound or CT scan Serum bilirubin greater than 2mg/dl, alkaline phosphatase and/or lipase more than 1.5 times upper limit of normal within 48 hours of intended first pro
Exclusion
- History of bleeding disorders, platelet count \<100,000 per mm³ and/or prothrombin time \>3 seconds over control
- Uremia as evidenced by a creatinine \> 3 mg/dl and/or blood urea nitrogen \> 50 mg/dl
- Ultrasonography or CT evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, or periampullary neoplasm
- Insulin-dependent diabetes mellitus
- Multiple prior laparotomies
- Morbid obesity
- Clinical, radiologic and/or biochemical evidence of cirrhosis or portal vein thrombosis
- Pregnancy
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00807729
Start Date
January 1 1997
End Date
November 1 2007
Last Update
September 3 2009
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110