NCT05186350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

January 6, 2022

Last Update Submit

February 18, 2023

Conditions

CholedocholithiasisCommon Bile Duct Calculi

Keywords

Choledocholithiasis; SpyGlass; ESWL;ERCP

Outcome Measures

Primary Outcomes (2)

  • Clearance rate(percentage)

    Stone clearance ratio

    1 month

  • Number of sessions

    Number of ERCP procedures

    1 month

Secondary Outcomes (2)

  • Complications

    1 month

  • Procedure Time

    Intraoperative

Study Arms (2)

SpyGlass group

ACTIVE COMPARATOR

ERCP plus SpyGlass group

Procedure: ERCP+ SpyGlass

ESWL group

ACTIVE COMPARATOR

ERCP plus ESWL

Procedure: ESWL+ ERCP

Interventions

ERCP+ SpyGlassPROCEDURE

SpyGlass direct Vision guided laser lithotripsy

SpyGlass group
ESWL+ ERCPPROCEDURE

ESWL + Stone removal through ERCP

ESWL group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • large bile duct stones (≥10 mm)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

Related Publications (4)

  • 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.

    PMID: 28785149BACKGROUND

  • [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.

    PMID: 31557778BACKGROUND

  • 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.

    PMID: 30943551BACKGROUND

  • Khizar H, Gu W, Zhou H, Yang J, Jin H, He X, Zhang X, Yang J. A comparative study of extracorporeal shock wave lithotripsy and cholangioscopy-guided lithotripsy in the management of complex biliary stones: A randomized trial. J Trauma Acute Care Surg. 2025 Oct 1;99(4):628-634. doi: 10.1097/TA.0000000000004693. Epub 2025 Aug 13.

    PMID: 40811584DERIVED

MeSH Terms

Conditions

CholedocholithiasisGallstones

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jianfeng Yang, Doctor

    Affilated Hangzhou First People Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 11, 2022

Study Start

January 1, 2021

Primary Completion

December 1, 2022

Study Completion

January 25, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)