Management of Borderline Common Bile Duct Stone

Study Overview
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Brief Summary
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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.

Detailed Description
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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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.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. 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. No improvement: the patient will undergo ERCP and then LC. Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.

Official Title
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Management and Outcome of Borderline Common Bile Duct With Stone

Conditions
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Common Bile Duct Stone

Intervention / Treatment
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* Procedure: conservative
* Procedure: ERCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: CBD diameter less than 10mm. Single or 2 stones in number. Size of stone 5mm or less. Serum bilirubin level less than 10 mg/dl . SGPT, SGOT less than 300. Associated gallbladder stones Exclusion Criteria: Previous cholecystectomy. History of acute cholecystitis, pancreatitis, or cholangitis. Previous history of endoscopic sphincterotomy. Unfit patients for cholecystectomy. No gallbladder stones. Patients with altered GIT anatomy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conservative<br>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. 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. No improvement: the patient will undergo ERCP and then LC. | Procedure: conservative<br>* 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.<br>* Other names: G 1;|
| Active Comparator: ERCP (endoscopic)<br>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. | Procedure: ERCP<br>* 2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.<br>* Other names: G 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete clearance rate of the CBD stones | complete clearance rate of the CBD stones | 30 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall complications | pancreatitis | 30 DAYS | 
| conversion rate during laparoscopic cholecystectomy | conversion rate during laparoscopic cholecystectomy | 1 day |