Laser Lithotripsy for Difficult Large Bile Duct Stones

Randomized Trial of Spyglass Guided Laser Lithotripsy Versus Dilation-Assisted Stone Extraction for the Endoscopic Removal of Difficult Large Bile Duct Stones

Very large bile duct stones are difficult to remove. Dilation-assisted stone extraction, also termed small endoscopic sphincterotomy plus endoscopic papillary large balloon dilatation, is safe and effective technique for the treatment of large CBD stones. However, in approximately 5-10% of patients, the removal of large bile duct stones may be difficult. For this selected group of patients for whom all conventional endoscopic stone treatment devices have failed, laser lithotripsy technology has provided an approach to the fragmentation of difficult bile duct stones.

A single-operator cholangioscopy (SOC) system (SpyGlass Direct Visualization System, Boston Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy limitations. The investigators aimed to evaluate the efficacy and safety of Spyglass-guided laser lithotripsy for difficult CBD stones not amenable to conventional dilation-assisted stone extraction therapy.

Study Overview

• Status: Unknown
• Conditions: Cholangiopancreatography, Endoscopic Retrograde; Sphincterotomy, Endoscopic; Lithotripsy, Laser
• Intervention / Treatment: Procedure: dilation-assisted stone extraction; Device: Spyglass Guided Laser Lithotrips

Detailed Description

Purpose Very large bile duct stones are difficult to remove.Dilation-assisted stone extraction, also termed small endoscopic sphincterotomy plus endoscopic papillary large balloon dilatation, is safe and effective technique for the treatment of large CBD stones.However, in approximately 5-10% of patients, the removal of large bile duct stones may be difficult. For this selected group of patients for whom all conventional endoscopic stone treatment devices have failed, laser lithotripsy technology has provided an approach to the fragmentation of difficult bile duct stones.

A single-operator cholangioscopy (SOC) system(SpyGlass Direct Visualization System, Boston Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy limitations.We aimed to evaluate the efficacy and safety of Spyglass-guided laser lithotripsy for difficult CBD stones not amenable to conventional dilation-assisted stone extraction therapy.

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment Official Title: Randomized Trial of Spyglass Guided Laser Lithotripsy Versus Dilation-Assisted Stone Extraction for the Endoscopic Removal of Difficult Large Bile Duct Stones

Primary Outcome Measures:

• Bile Duct Stone Clearance Confirmation that no further stones remain in the bile duct of the patient by cholangiography. Additionally, serum laboratory abnormalities in AST, ALT, Alkaline Phophatase, or bilirubin, or epigastric abdominal pain attributable to bile duct stones.

Secondary Outcome Measures:

• Number of ERCP
• The number of ERCP procedures required to complete clearance of bile duct stones.
• Total Procedure Time
• The total time in minutes for all the ERCP procedures required for stone removal.
• Estimated Procedure Cost
• The cost of patient management for bile duct stones based on the cost of the procedure, hospitalization, and associated costs of complications of cholangitis, pancreatitis, perforation, and bleeding.
• Cholangitis Cholangitis after or between ERCP procedures will be defined as a presentation with epigastric abdominal pain, temperature greater than 38.5 Celsius accompanied by either laboratory abnormalities of the AST, ALT, Alkaline Phosphatase, or Bilirubin or abnormal imaging of the biliary tree on ultrasound,computed tomography scan, or magnetic resonance cholangiopancreatography.
• Pancreatitis
• Pancreatitis following or between ERCP procedures will be defined as the onset of epigastric abdominal pain and either amylase or lipase greater than 3 times the upper limit of normal or findings on ultrasound, computed tomography scan, or magnetic resonance cholangiopancreatography suggestive of pancreatic inflammation.
• Bleeding
• Bleeding attributable to stone therapy will be defined as a drop in hemoglobin by more than 1 gm/dl following or between ERCP procedures with no other cause identified on standard clinical evaluation.

Eligibility

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria

Inclusion Criteria:

• Bile duct stone >1.5cm demonstrated on ultrasound, computed tomography, or magnetic resonance imaging

Exclusion Criteria:

• Biliary, gallbladder or pancreatic malignancy
• Pregnant
• Prior biliary diversion surgery
• Under age 18
• Unable to give informed consent

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bile duct stone >1.5cm demonstrated on ultrasound, computed tomography, or magnetic resonance imaging

Exclusion Criteria:

• Biliary, gallbladder or pancreatic malignancy
• Pregnant
• Prior biliary diversion surgery
• Under age 18
• Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dilation-assisted group; Dilation-assisted group:Dilation-assisted stone extraction	Procedure: dilation-assisted stone extraction
Other: laser lithotripsy group; laser lithotripsy group:laser lithotripsy	Device: Spyglass Guided Laser Lithotrips

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bile Duct Stone Clearance	1 hour

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 30, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: sdqfs001