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Evaluation of the best line of treatment of borderline CBD stones associated with gallbladder stones whether by conservative treatment or endoscopic stone extraction as regard complete clearance rate of the CBD stones followed by laparoscopic cholecystectomy. The secondary outcomes are overall complications related to each approach, technical difficulties and conversion rate during laparoscopic cholecystectomy and cost benefit relationship of each line of treatment.
Enrolled patients in the study will be randomized to either conservative treatment or ERCP and stone extraction. The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.
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.
Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conservative | Active Comparator | 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.
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| ERCP (endoscopic) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conservative | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| complete clearance rate of the CBD stones | complete clearance rate of the CBD stones | 30 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| overall complications | pancreatitis | 30 DAYS |
| conversion rate during laparoscopic cholecystectomy | conversion rate during laparoscopic cholecystectomy |
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Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman El Nakeeb, MD | Mansoura University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16627230 | Result | 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. | |
| 16718834 | Result | 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. |
| Label | URL |
|---|---|
| mansoura university | View source |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
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|
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| ERCP | Procedure | 2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days. |
|
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| 1 day |
| 20645517 | Result | 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. |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003952 |
| Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |