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SpyGlass Versus ESWL for Large Common Bile Duct Stones

Primary Purpose

Choledocholithiasis, Common Bile Duct Calculi

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ERCP+ SpyGlass
ESWL+ ERCP
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis focused on measuring Choledocholithiasis; SpyGlass; ESWL;ERCP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hangzhou First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SpyGlass group

ESWL group

Arm Description

ERCP plus SpyGlass group

ERCP plus ESWL

Outcomes

Primary Outcome Measures

Clearance rate(percentage)
Stone clearance ratio
Number of sessions
Number of ERCP procedures

Secondary Outcome Measures

Complications
Side effect of the procedures
Procedure Time
Time spent for each surgery

Full Information

First Posted
January 6, 2022
Last Updated
February 18, 2023
Sponsor
First People's Hospital of Hangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05186350
Brief Title
SpyGlass Versus ESWL for Large Common Bile Duct Stones
Official Title
Comparison of SpyGlass Guided Lithotripsy Versus Extracorporeal Shockwaves Lithotripsy for Large Common Bile Duct Stones
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Common Bile Duct Calculi
Keywords
Choledocholithiasis; SpyGlass; ESWL;ERCP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SpyGlass group
Arm Type
Active Comparator
Arm Description
ERCP plus SpyGlass group
Arm Title
ESWL group
Arm Type
Active Comparator
Arm Description
ERCP plus ESWL
Intervention Type
Procedure
Intervention Name(s)
ERCP+ SpyGlass
Intervention Description
SpyGlass direct Vision guided laser lithotripsy
Intervention Type
Procedure
Intervention Name(s)
ESWL+ ERCP
Intervention Description
ESWL + Stone removal through ERCP
Primary Outcome Measure Information:
Title
Clearance rate(percentage)
Description
Stone clearance ratio
Time Frame
1 month
Title
Number of sessions
Description
Number of ERCP procedures
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Complications
Description
Side effect of the procedures
Time Frame
1 month
Title
Procedure Time
Description
Time spent for each surgery
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Yang, Doctor
Organizational Affiliation
Affilated Hangzhou First People Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28785149
Citation
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.
Results Reference
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PubMed Identifier
31557778
Citation
[French comment on article Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates]. Endoscopy. 2019 Oct;51(10):1006-1007. doi: 10.1055/a-1000-5911. Epub 2019 Sep 26. No abstract available. French.
Results Reference
background
PubMed Identifier
30943551
Citation
Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.
Results Reference
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SpyGlass Versus ESWL for Large Common Bile Duct Stones

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