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

ConditionBiliary Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with complicated biliary stones

Patients older than 18 years old

Patients where informed consent can be obtained

Disqualifiers

Patients who cannot give informed consent

Patients under 18 years old

Pregnant or lactating patients

Patient with altered gastrointestinal/biliary anatomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spyglass DS cholangioscope

    Device

    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

  • BML

    Device

    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.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: LASER ARMExperimental treatment 1 intervention
Group B: CONVENTIONAL ARMActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall rate of endoscopic bile duct stone clearance

Overall rate of endoscopic bile duct stone clearance

Time frame
Intraoperative

Secondary outcomes

1

Technical feasibility

Technical feasibility defined as successful introduction of cholangioscope into the CBD, visualisation and laser targeting of stone

Time frame
Intraoperative
2

Incidence of adverse events

Incidence of adverse events

Time frame
30 days
3

Need for and number of additional procedures for stone clearance

Need for and number of additional procedures for stone clearance

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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