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

NARecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

June 14, 2016

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Biliary Stones
Interventions
DEVICE

Spyglass DS cholangioscope

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

DEVICE

BML

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.

Trial Locations (1)

Unknown

RECRUITING

Endoscopy Centre, Prince of Wales Hospital, Hong Kong

All Listed Sponsors
lead

Chinese University of Hong Kong

OTHER