Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2012-04-30
2015-03-31
Brief Summary
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Detailed Description
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1. Patients in conservative treatment group will receive medical treatment in the form of antibiotics, analgesics and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones.
1. Improvement: If the stone spontaneously passes to the duodenum and CBD is clear completely from the stones proved by US, the patient will undergo laparoscopic cholecystectomy (LC) within 3 days.
2. No improvement: the patient will undergo ERCP and then LC.
2. Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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conservative
1- Patients in conservative treatment group will receive medical treatment in the form of antibiotics (3rd generation cephalosporine), analgesics (NSAID eg Ibuprofen ) and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones.
1. Improvement: If the stone spontaneously passes to the duodenum and CBD is clear completely from the stones proved by US, the patient will undergo laparoscopic cholecystectomy (LC) within 3 days.
2. No improvement: the patient will undergo ERCP and then LC.
conservative
1- Patients in conservative treatment group will receive medical treatment in the form of antibiotics (3rd generation cephalosporine), analgesics (NSAID eg Ibuprofen) and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones.
ERCP (endoscopic)
2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.cholecystectomy (LC) within 3 days.
b- No improvement: the patient will undergo ERCP and then LC.
ERCP
2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
Interventions
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conservative
1- Patients in conservative treatment group will receive medical treatment in the form of antibiotics (3rd generation cephalosporine), analgesics (NSAID eg Ibuprofen) and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones.
ERCP
2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Single or 2 stones in number.
3. Size of stone 5mm or less.
4. Serum bilirubin level less than 10 mg/dl .
5. SGPT, SGOT less than 300.
6. Associated gallbladder stones
Exclusion Criteria
2. History of acute cholecystitis, pancreatitis, or cholangitis.
3. Previous history of endoscopic sphincterotomy.
4. Unfit patients for cholecystectomy.
5. No gallbladder stones.
6. Patients with altered GIT anatomy.
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ayman El Nakeeb
Gastroenterology surgical center, mansoura university
Principal Investigators
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Ayman El Nakeeb, MD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
References
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Hungness ES, Soper NJ. Management of common bile duct stones. J Gastrointest Surg. 2006 Apr;10(4):612-9. doi: 10.1016/j.gassur.2005.08.015. No abstract available.
Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: evolving standards for diagnosis and management. World J Gastroenterol. 2006 May 28;12(20):3162-7. doi: 10.3748/wjg.v12.i20.3162.
Samardzic J, Latic F, Kraljik D, Pitlovic V, Mrkovic H, Miskic D, Latic A, Delibegovic S. Treatment of common bile duct stones--is the role of ERCP changed in era of minimally invasive surgery? Med Arh. 2010;64(3):187-8.
Related Links
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mansoura university
Other Identifiers
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borderline CBDS
Identifier Type: -
Identifier Source: org_study_id
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