Laser Versus Mechanical Lithotripsy of Bile Duct Stones

NCT01759979 | Completed DMC

• 1 other identifier: HS-11-00718
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Very large bile duct stones are difficult to remove. The prefered method involves an endoscopic procedure known as endoscopic retrograde cholangiopancreatography (ERCP)performed using a special side viewing endoscope. In the past small baskets passed through the scope into the bile duct have been used to remove most stones using mechanical force. Recently very small scopes known as cholangioscope have been introduced through the side viewing endoscope directly into the bile duct. These cholangioscopes may be used to guide laser therapy of bile duct stones. The investigators suspect that stone destruction using cholangioscopy guided laser stone destruction may enable bile duct stones to be removed more quickly and safely when added to the mechanical techniques.

Conditions

Choledocholithiasis

Keywords

Cholelithiasis, Common Bile Duct; Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Number of ERCP

  12 months

• Total Procedure Time

  12 months

• Estimated Procedure Cost

  12 months

• Cholangitis

  12 months

• Pancreatitis

  12 months

Study Arms (2)

Laser and mechanical lithotripsy

EXPERIMENTAL

Bile duct stones with be treated with cholangioscopy guided laser therapy in addition to mechanical basket and balloon techniques.

Procedure: Laser and mechanical lithotripsy

Mechanical lithotripsy

ACTIVE COMPARATOR

Patients in the mechanical lithotripsy arm will undergo treatment only with basket and balloon for removal of large stones.

Procedure: Mechanical Lithotripsy

Interventions

Laser and mechanical lithotripsy PROCEDURE

Patients will undergo cholangioscopy guided laser treatment in addition to treatment with mechanical lithotripsy using basket and balloon techniques.

Also known as: Spyglass cholangioscopy, Holmium laser lithotripsy

Laser and mechanical lithotripsy

Mechanical Lithotripsy PROCEDURE

Patients in the mechanical lithotripsy arm will undergo treatment only with basket and balloons to facilitate stone removal but not laser lithotripsy.

Mechanical lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bile duct stone \>1cm demonstrated on ultrasound, computed tomography, or magnetic resonance imaging
• Bile duct dilatation \>1cm

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (5)

• Lee JG. Diagnosis and management of acute cholangitis. Nat Rev Gastroenterol Hepatol. 2009 Sep;6(9):533-41. doi: 10.1038/nrgastro.2009.126. Epub 2009 Aug 4.

  PMID: 19652653 BACKGROUND

• Moon JH, Ko BM, Choi HJ, Hong SJ, Cheon YK, Cho YD, Lee JS, Lee MS, Shim CS. Intraductal balloon-guided direct peroral cholangioscopy with an ultraslim upper endoscope (with videos). Gastrointest Endosc. 2009 Aug;70(2):297-302. doi: 10.1016/j.gie.2008.11.019. Epub 2009 Apr 25.

  PMID: 19394010 BACKGROUND

• Kim HI, Moon JH, Choi HJ, Lee JC, Ahn HS, Song AR, Lee TH, Cho YD, Park SH, Kim SJ. Holmium laser lithotripsy under direct peroral cholangioscopy by using an ultra-slim upper endoscope for patients with retained bile duct stones (with video). Gastrointest Endosc. 2011 Nov;74(5):1127-32. doi: 10.1016/j.gie.2011.07.027. Epub 2011 Sep 29.

  PMID: 21963070 BACKGROUND

• Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.

  PMID: 21762903 BACKGROUND

• Langman MJ, Constantinopoulos A, Bouchier IA. ABO blood groups, secretor status, and intestinal mucosal concentrations of alkaline phosphatase. Nature. 1968 Mar 2;217(5131):863-5. doi: 10.1038/217863a0. No abstract available.

  PMID: 5641153 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• James L Buxbaum, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy, Los Angeles County Hospital

Study Record Dates

• First Submitted: December 31, 2012
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)