None listed
Conditions
Brief summary
Current practice in the management of CBD stones varies widely with most patients receiving either pre or post operative ERCP. This is a two-step approach to the management of CBD stones. A one-step approach to CBD stones exists in the form of open or laparoscopic CBD exploration (either laparoscopic transcystic exploration (TCE) or laparoscopic choledochotomy). We aim to assess the practice of performing a single-step approach to CBD stones by performing either intra-operative ERCP or LCBDE once a CBD stone is identified.
Interventions
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure involving the use of a side-viewing duodenoscope to perform interventions on the biliary tract (bile ducts). These interventions include, but are not limited to: the use of radio-opaque contrast dye to image the bile and pancreatic ducts, the use of sphincterotomes to incise the sphincter of the bile duct (sphincter of Oddi), the use of balloons or basket extraction devices to remove stones, placement of stents for
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure involving the use of a side-viewing duodenoscope to perform interventions on the biliary tract (bile ducts). These interventions include, but are not limited to: the use of radio-opaque contrast dye to image the bile and pancreatic ducts, the use of sphincterotomes to incise the sphincter of the bile duct (sphincter of Oddi), the use of balloons or basket extraction devices to remove stones, placement of stents for biliary or pancreatic drainage. ERCP is usually performed under fluoroscopic guidance and thus involves radiation exposure. The procedure usually lasts between 15-60 mins, depending on the experience of the endoscopist. The study recruitment period is 3 years and duration of follow-up is at least 6 months.
Sponsors
Department of Upper GI/HPB Surgery, Monash Medical Centre
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 99 Years
Healthy volunteers
No
Inclusion criteria
Patients undergoing emergency laparoscopic cholecystectomy with common bile duct stones demonstrated intra-operatively on cholangiogram
Exclusion criteria
Pregnant women Children (patients under the age of 18) Patients with post-surgical anatomy precluding routine endoscopic access to the ampulla of Vater (Billroth II reconstruction, any form of Roux-en-Y reconstruction) Severe cholangitis [1] Severe pancreatitis [2] 1. Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, et al. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). Journal of Hepato-Biliary-Pancreatic Sciences. 2013 Jan 11; 20: 24–34. 2. Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2012 Dec 7; 62: 102–111.
Outcome results
None listed