None listed
Conditions
Brief summary
The ideal management of common bile duct stones (CBD) in the era of laparoscopic cholecystectomy remains controversial. However, ERCP remains the prevailing method of treating CBD stones, but its ideal timing in respect to laparoscopic cholecystectomy is not defined yet.
Interventions
Single-stage treatment with intraoperative ERCP (ERCP is a technique that combines the use of endoscopy and fluoroscopy to diagnose and treat certain disease of the biliary or pancreatic ductal systems, e.g. biliary stone. Then a flexible endoscope is inserted through the mouth, into the duodenum where the ampulla of Vater exists. The region can be directly visualized with the endoscopic camera. A plastic cannula is inserted through the ampulla, and radiocontrast is injected into the bile ducts.
Single-stage treatment with intraoperative ERCP (ERCP is a technique that combines the use of endoscopy and fluoroscopy to diagnose and treat certain disease of the biliary or pancreatic ductal systems, e.g. biliary stone. Then a flexible endoscope is inserted through the mouth, into the duodenum where the ampulla of Vater exists. The region can be directly visualized with the endoscopic camera. A plastic cannula is inserted through the ampulla, and radiocontrast is injected into the bile ducts. Fluoroscopy is used to look for any pathology such as stones. Then, endoscopist can treat it accordingly. The procedure lasts around 30 minutes) and laparoscopic cholecystectomy (Gallbladder with stones was dissected and removed by minimally invasive surgery with laparoscopic approach by four small wound ports. Intraoperative cholangiogram may be performed also, if needed. The procedure lasts around 90 minutes); Patients will undergo laparoscopic cholecystectomy and intraoperative ERCP simutaneously under general anestheisa.
Sponsors
Department of Surgery, Pamela Youde Nethersole Eastern Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ranged from 18-75 years old 2. Patients with ultrasonography(USG)/magnetic resonance cholangiopancreatography (MRCP)/computed tomography (CT) scan evidence of gallbladder stones and common bile duct (CBD) stones 3. Patients recovered from episode of acute cholangitis or biliary pancreatitis, and were treated with ERCP and temporary biliary stenting for the biliary stone obstruction during acute phase. Patients were randomized only if they demonstrated evidence of resolved acute episode, as determined by a decreasing white cell count, bilirubin level, fever and reduced abdominal pain
Exclusion criteria
1. Patients with acute cholangitis or acute severe pancreatitis at acute phase 2. American Society of Anesthesiologists (ASA) class IV and V health status 3. Patients with suspected biliary malignancy 4. Patients with Mirizzi syndrome 5. Patients with recurrent pyogenic cholangitis 6. Patients with previous cholecystectomy/bile duct exploration/gastrectomy 7. Patients have contraindications to ERCP/laparoscopic surgery 8. On long term anticoagulant treatment
Outcome results
None listed