Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones

August 20, 2023 updated by: James Yun-wong Lau, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • NT
      • Hong Kong, NT, Hong Kong
        • Recruiting
        • Endoscopy Centre, Prince of Wales Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LASER ARM
Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy
The 1.8Fr holmium:YAG laser fiber (Lumenis, Yokneam, Israel) will be inserted into the cholangioscope's working channel for lithotripsy under direct visualization. An EHL probe may alternatively be used depending on availability. Lithotripsy is applied until fragments of the targeted stone are no longer lumen filling, and can be dispersed easily with fluid irrigation. Fragmented stones are then removed by a combination of conventional techniques. To confirm stone clearance, the Spyglass DS cholangioscope will be re-introduced, and the bile duct will be examined for residual stones from the confluence of the right and left intrahepatic ducts to the papillary opening
Active Comparator: CONVENTIONAL ARM
Stone removal by conventional techniques, for example BML, without laser lithotripsy
Biliary sphincterotomy with/without EPBD to the size of the lower bile duct with a limit of 15mm will be performed. Stones are removed by a combination of conventional BML, extraction balloon and/or baskets, without laser lithotripsy. An occlusion cholangiogram is performed to confirm stone clearance. In cases where stone clearance is incomplete, a plastic biliary stent bridging the stone will be inserted for temporary drainage until definitive management, usually within one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall rate of endoscopic bile duct stone clearance
Time Frame: Intraoperative
Overall rate of endoscopic bile duct stone clearance
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical feasibility
Time Frame: Intraoperative
Technical feasibility defined as successful introduction of cholangioscope into the CBD, visualisation and laser targeting of stone
Intraoperative
Incidence of adverse events
Time Frame: 30 days
Incidence of adverse events
30 days
Need for and number of additional procedures for stone clearance
Time Frame: 6 months
Need for and number of additional procedures for stone clearance
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James LAU, MD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2016

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 20, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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