Common Bile Duct Stone Clinical Trial
Official title:
Management and Outcome of Borderline Common Bile Duct With Stone
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will be withdrawn by a nurse in the outpatient clinic.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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