SpyGlass Versus ESWL for Large Common Bile Duct Stones | NCT05186350

Studies
SpyGlass Versus ESWL for Large Common Bile Duct Stones

NCT05186350

Sponsor

First People's Hospital of Hangzhou

Status

Completed

Last Update Posted

Feb 21, 2023Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Choledocholithiasis
Common Bile Duct Calculi

Interventions

ERCP+ SpyGlass
ESWL+ ERCP

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Jan 25, 2023Actual

First Submitted Date

Jan 6, 2022

First Submission Date that Met QC Criteria

Jan 10, 2022

First Posted Date

Jan 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2023

Last Update Posted Date

Feb 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianfeng Yang, Professor, First People's Hospital of HangzhouPrincipal Investigator

Lead Sponsor

First People's Hospital of HangzhouOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis is a big problem, especially for stones with a diameter greater than 3cm. After ERCP failure, surgery was the option but patients not suitable for surgery were treated through stenting but had to undergo multiple ERCPs and show a success rate of only 44-96%. Recently, choledochoscopic laser, electrohydraulic lithotripsy, SpyGlass, or extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge bile duct stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile duct stones.

Detailed Description

ESWL was first used for the removal of renal calculi and ureteral calculi however, now a day is being used for biliary calculi. It has the advantages of simple operation, low cost, and higher safety. Recent studies show that the procedure time for ESWL is also shorter and the utilization rate of mechanical lithotripsy was effectively reduced with fewer complications. But It is difficult for ESWL to break the stones larger than 3cm into small pieces. So SpyGlass-guided laser lithotripsy is used. Spyglass has been used in clinics for more than ten years. Recently, a study reported difficult bile duct stones that were treated with SpyGlass-guided laser lithotripsy that shows promising results. Compared with laser lithotripsy under X-ray monitoring, there is no significant difference in stone removal rate and complication rate between the two methods. However, the effect of lithotripsy under Spyglass direct vision is better, which can break large stones into smaller pieces, thus making it easier to take stones. The investigators conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile duct stones

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SpyGlass group	Active Comparator	ERCP plus SpyGlass group	Procedure: ERCP+ SpyGlass
ESWL group	Active Comparator	ERCP plus ESWL	Procedure: ESWL+ ERCP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERCP+ SpyGlass	Procedure	SpyGlass direct Vision guided laser lithotripsy	SpyGlass group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clearance rate(percentage)	Stone clearance ratio	1 month
Number of sessions	Number of ERCP procedures	1 month

Secondary Outcomes

Measure	Description	Time Frame
Complications	Side effect of the procedures	1 month
Procedure Time	Time spent for each surgery	Intraoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

large bile duct stones (≥10 mm)

Exclusion Criteria:

pregnancy
refusal of written informed consent
Patients with benign or malignant biliary stricture
Contraindications to ERCP exist
Complicated with acute pancreatitis or acute cholangitis
Coagulation dysfunction#thrombocytopenia
Patients after gastrointestinal reconstruction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jianfeng Yang, Doctor	Affilated Hangzhou First People Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hangzhou First People's Hospital		Hangzhou	Zhejiang	31006	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28785149	Background	Tao T, Zhang M, Zhang QJ, Li L, Li T, Zhu X, Li MD, Li GH, Sun SX. Outcome of a session of extracorporeal shock wave lithotripsy before endoscopic retrograde cholangiopancreatography for problematic and large common bile duct stones. World J Gastroenterol. 2017 Jul 21;23(27):4950-4957. doi: 10.3748/wjg.v23.i27.4950.
31557778

ID	Term
D042883	Choledocholithiasis
D042882	Gallstones

ID	Term
D003137	Common Bile Duct Diseases
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases