Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones
Randomized Controlled Trial of Spyglass DS Peroral Cholangioscope Guided Laser Lithotripsy or Electrohydraulic Lithotripsy Versus Conventional Basket Mechanical Lithotripsy for Endoscopic Removal of Complicated Bile Duct Stones
Chinese University of Hong Kong
86 participants
Jun 14, 2016
INTERVENTIONAL
Conditions
Summary
This study aims to compare the overall rate of endoscopic clearance of complicated bile duct stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser/electrohydraulic lithotripsy versus conventional BML.
Eligibility
Inclusion Criteria3
- Patients with complicated biliary stones
- Patients older than 18 years old
- Patients where informed consent can be obtained
Exclusion Criteria9
- Patients who cannot give informed consent
- Patients under 18 years old
- Pregnant or lactating patients
- Patient with altered gastrointestinal/biliary anatomy
- Patients with distal CBD malignant stricture from intrinsic or extrinsic causes
- Patients with ongoing cholangitis or biliary pancreatitis
- Patient with refractory bleeding tendencies (Platelet count <50,000/mm3 or International Normalized Ratio >1.5 despite correction with platelet or fresh frozen plasma transfusions)
- Patients with intrahepatic segmental stones
- Patients with contraindications to endoscopy due to comorbidities
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The 1.8Fr holmium:YAG laser fiber (Lumenis, Yokneam, Israel) will be inserted into the cholangioscope's working channel for lithotripsy under direct visualization. An EHL probe may alternatively be used depending on availability. Lithotripsy is applied until fragments of the targeted stone are no longer lumen filling, and can be dispersed easily with fluid irrigation. Fragmented stones are then removed by a combination of conventional techniques. To confirm stone clearance, the Spyglass DS cholangioscope will be re-introduced, and the bile duct will be examined for residual stones from the confluence of the right and left intrahepatic ducts to the papillary opening
Biliary sphincterotomy with/without EPBD to the size of the lower bile duct with a limit of 15mm will be performed. Stones are removed by a combination of conventional BML, extraction balloon and/or baskets, without laser lithotripsy. An occlusion cholangiogram is performed to confirm stone clearance. In cases where stone clearance is incomplete, a plastic biliary stent bridging the stone will be inserted for temporary drainage until definitive management, usually within one month.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03244163