Clinical trial NCT03244163: Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Biliary Stones
Keywords: Spyglass DS
Laser lithotripsy
Endoscopic retrograde cholangiopancreatography
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Currently, complicated bile duct stones are removed during endoscopic retrograde cholangiopancreatography (ERCP) by conventional mechanical lithotripsy, which means using a metal wire basket to capture the stone and crush it to make it easier to remove. This is successful in approximately 70% of patients, with the success rate inversely correlated to the size of the stone. Unsuccessful stone removal would require additional endoscopic, percutaneous or surgical interventions. Spyglass DS peroral cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy is a recent alternate method for managing complicated bile duct stones. Also performed during ERCP, a thin flexible camera (called Spyglass DS peroral cholangioscope) is inserted into the bile duct to visualize the stone which can then be targeted by a laser beam for fragmentation (also known as laser lithotripsy). The smaller pieces are then removed. Direct comparisons of these procedures' efficacy however have not been performed.

The purpose of this study is to compare the efficacy and safety of Spyglass DS peroral cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy (the laser arm) versus conventional basket mechanical lithotripsy alone (the conventional arm) for fragmentation and clearance of complicated bile duct stones.

Eligibility criteria: Inclusion Criteria:

* Patients with complicated biliary stones
* Patients older than 18 years old
* Patients where informed consent can be obtained

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall rate of endoscopic bile duct stone clearance
timeFrame: Intraoperative
Secondary outcomes:
measure: Technical feasibility
timeFrame: Intraoperative
measure: Incidence of adverse events
timeFrame: 30 days
measure: Need for and number of additional procedures for stone clearance
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Endoscopy Centre, Prince of Wales Hospital
state: NT
Study officials:
affiliation: Chinese University of Hong Kong
name: James LAU, MD
role: PRINCIPAL_INVESTIGATOR
References: