Laser Lithotripsy for Difficult Large Bile Duct Stones

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02538731
• Other study ID #: sdqfs001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2015
• Last updated: September 1, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: china:Shandong Provincial Planning Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Lithotripsy, Laser
• Sphincterotomy, Endoscopic

Intervention

Procedure:
• dilation-assisted stone extraction

Device:
• Spyglass Guided Laser Lithotrips

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile Duct Stone Clearance		1 hour	Yes