CholedocholithiasisNCT05186350
SpyGlass Versus ESWL for Large Common Bile Duct Stones
A study testing ERCP+ SpyGlass and ESWL+ ERCP in people with Choledocholithiasis and Common Bile Duct Calculi, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis is a big problem, especially for stones with a diameter greater than 3cm. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Choledocholithiasis, Common Bile Duct Calculi
- What is being tested?
- ERCP+ SpyGlass and ESWL+ ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- large bile duct stones (≥10 mm)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of SpyGlass Guided Lithotripsy Versus Extracorporeal Shockwaves Lithotripsy for Large Common Bile Duct Stones
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.
Read the 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
- Conditions
- Choledocholithiasis, Common Bile Duct Calculi
- Being tested
- ERCP+ SpyGlass, ESWL+ ERCP
- Keywords
- Choledocholithiasis; SpyGlass; ESWL;ERCP
- Medical subject headings
- Choledocholithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP+ SpyGlassProcedure or surgery
SpyGlass direct Vision guided laser lithotripsy
ESWL+ ERCPProcedure or surgery
ESWL + Stone removal through ERCP
| Study group | Role | What they receive |
|---|---|---|
| SpyGlass group | Active comparator | ERCP plus SpyGlass group Receives: Procedure: ERCP+ SpyGlass |
| ESWL group | Active comparator | ERCP plus ESWL Receives: Procedure: ESWL+ ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate(percentage)
Stone clearance ratio
Measured: 1 month
Number of sessions
Number of ERCP procedures
Measured: 1 month
Secondary outcomes (2)
Complications
Side effect of the procedures
Measured: 1 month
Procedure Time
Time spent for each surgery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2021
- Primary completion1 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Jianfeng Yang, Doctor, Principal investigator, Affilated Hangzhou First People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186350
- Sponsor's protocol ID
- 2022-01-06
- Status last verified
- Feb 2023
- First submitted
- 6 Jan 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28785149[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.
PubMed 31557778Manes 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.
PubMed 30943551Khizar 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.
PubMed 40811584
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SpyGlass Guided Lithotripsy Versus Extracorporeal Shockwaves Lithotripsy for Large Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT05186350
- Acronym / sponsor ID
- 2022-01-06
- Conditions
- Choledocholithiasis, Common Bile Duct Calculi
- Keywords
- Choledocholithiasis; SpyGlass; ESWL;ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| SpyGlass group | Active comparator | Procedure: ERCP+ SpyGlassERCP plus SpyGlass group |
| ESWL group | Active comparator | Procedure: ESWL+ ERCPERCP plus ESWL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- large bile duct stones (≥10 mm)
Key exclusion criteria (7 listed)
- pregnancy
- refusal of written informed consent
- Patients with benign or malignant biliary stricture
- Contraindications to ERCP exist
- Complicated with acute pancreatitis or acute cholangitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP+ SpyGlassSpyGlass direct Vision guided laser lithotripsy | Procedure or surgery | SpyGlass group |
| ESWL+ ERCPESWL + Stone removal through ERCP | Procedure or surgery | ESWL group |
Primary outcome
Clearance rate(percentage)
Time frame: 1 month
Stone clearance ratio
Number of sessions
Time frame: 1 month
Number of ERCP procedures
2 secondary outcomes
Complications
Time frame: 1 month
Procedure Time
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 28785149Tao 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.
- Background: PubMed 31557778[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.
- Background: PubMed 30943551Manes 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.
- Derived from this study: PubMed 40811584Khizar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfeng Yang, Doctor principal investigator
Affilated Hangzhou First People Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP+ SpyGlass and ESWL+ ERCP in people with Choledocholithiasis and Common Bile Duct Calculi, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance rate(percentage) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186350, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.