Laser Lithotripsy for Difficult Large Bile Duct Stones

NCT ID: NCT02538731

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-12-31

Brief Summary

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.

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

Conditions

Sphincterotomy, Endoscopic; Cholangiopancreatography, Endoscopic Retrograde; Lithotripsy, Laser

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dilation-assisted group

Dilation-assisted group:Dilation-assisted stone extraction

Group Type: OTHER

dilation-assisted stone extraction

Intervention Type: PROCEDURE

laser lithotripsy group

laser lithotripsy group:laser lithotripsy

Group Type: OTHER

Spyglass Guided Laser Lithotrips

Intervention Type: DEVICE

Interventions

dilation-assisted stone extraction

Intervention Type: PROCEDURE

Spyglass Guided Laser Lithotrips

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

guodong li

guodong li

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

sdqfs001

Identifier Type: -

Identifier Source: org_study_id