Pancreatic Duct StoneNCT05475782
Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones
A study testing Spyglass-guided lithotripsy and ESWL in people with Pancreatic Duct Stone, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for pancreatic duct stones is a amjor problem, especially bigger size stones. After ERCP failure, surgery was the only option but patients not suitable for surgery were treated through stenting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Duct Stone
- What is being tested?
- Spyglass-guided lithotripsy and ESWL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Dec 2025
- 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
- Pancreatic duct sone
- Falied to eliminate through ERCP only
Who cannot join
- Pregnancy
- Refusal of written informed consent
- Patients not suitable for ESWL/ Spyglass
- Contraindications to ERCP exist
- Complicated with acute pancreatitis or acute cholangitis
- Coagulation dysfunction#thrombocytopenia
- Patients after gastrointestinal reconstruction
- Allergic to drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones
Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for pancreatic duct stones is a amjor problem, especially bigger size stones. After ERCP failure, surgery was the only option but patients not suitable for surgery were treated through stenting. But had to undergo multiple ERCPs and show lower success rate. Recently, SpyGlass and extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass-guided lithotripsy and ESWL procedures for the removal of pancreatic 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 pancreatic duct stones and biliary calculi. It has the advantages of simple operation, lower 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.
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. Investigator conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large pancreatic duct stones.
- Conditions
- Pancreatic Duct Stone
- Being tested
- Spyglass-guided lithotripsy, ESWL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spyglass-guided lithotripsyProcedure or surgery
Also called Direct vision system
Spyglass-guided lithotripsy
ESWLProcedure or surgery
Also called Lithotripsy through ESWL
ESWL+ERCP
| Study group | Role | What they receive |
|---|---|---|
| Spyglass group | Active comparator | lithotripsy through Spyglass and ERCP Receives: Procedure: Spyglass-guided lithotripsy |
| ESWL group | Experimental | Lithotripsy through ESWL and ERCP Receives: Procedure: ESWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Successfull intervention
Measured: Intraoperative
Clinical success
Pancreatic duct stone clearance rate
Measured: 1 month
Secondary outcomes (3)
Adverse events
procedure related adverse events, bleeding, pancreatitis, etc
Measured: 1 month
Total number of ERCP
Number of ERCPs performed for stone clearnce
Measured: 1 month
Procedure sessions
Total sessions of therapy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jan 2021
- Primary completion30 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Duct StoneStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 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, MD, Principal investigator, Affilated Hangzhou First People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475782
- Sponsor's protocol ID
- 2022-07-25
- Status last verified
- May 2026
- First submitted
- 25 Jul 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guzman-Calderon E, Martinez-Moreno B, Casellas JA, Aparicio JR. Per-oral pancreatoscopy-guided lithotripsy for the endoscopic management of pancreatolithiasis: A systematic review and meta-analysis. J Dig Dis. 2021 Oct;22(10):572-581. doi: 10.1111/1751-2980.13041.
PubMed 34436824Bick BL, Patel F, Easler JJ, Tong Y, Watkins JL, McHenry L, Lehman G, Fogel EL, Gromski MA, Sherman S. A comparative study between single-operator pancreatoscopy with intraductal lithotripsy and extracorporeal shock wave lithotripsy for the management of large main pancreatic duct stones. Surg Endosc. 2022 May;36(5):3217-3226. doi: 10.1007/s00464-021-08631-7. Epub 2021 Jul 15.
PubMed 34264399Tandan M, Reddy DN. Extracorporeal shock wave lithotripsy for pancreatic and large common bile duct stones. World J Gastroenterol. 2011 Oct 21;17(39):4365-71. doi: 10.3748/wjg.v17.i39.4365.
PubMed 22110261van Huijgevoort NCM, Veld JV, Fockens P, Besselink MG, Boermeester MA, Arvanitakis M, van Hooft JE. Success of extracorporeal shock wave lithotripsy and ERCP in symptomatic pancreatic duct stones: a systematic review and meta-analysis. Endosc Int Open. 2020 Aug;8(8):E1070-E1085. doi: 10.1055/a-1171-1322. Epub 2020 Jul 21.
PubMed 32743061Beyna T, Neuhaus H, Gerges C. Endoscopic treatment of pancreatic duct stones under direct vision: Revolution or resignation? Systematic review. Dig Endosc. 2018 Jan;30(1):29-37. doi: 10.1111/den.12909. Epub 2017 Jul 27.
PubMed 28656688
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones
- ClinicalTrials.gov ID
- NCT05475782
- Acronym / sponsor ID
- 2022-07-25
- Conditions
- Pancreatic Duct Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Jul 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 pancreatic duct stones is a amjor problem, especially bigger size stones. After ERCP failure, surgery was the only option but patients not suitable for surgery were treated through stenting. But had to undergo multiple ERCPs and show lower success rate. Recently, SpyGlass and extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass-guided lithotripsy and ESWL procedures for the removal of pancreatic 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 pancreatic duct stones and biliary calculi. It has the advantages of simple operation, lower 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.
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. Investigator conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large pancreatic duct stones.
Study design
- Primary purpose
- Treatment
- Allocation
- 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: Spyglass-guided lithotripsylithotripsy through Spyglass and ERCP |
| ESWL group | Experimental | Procedure: ESWLLithotripsy through ESWL and ERCP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pancreatic duct sone
- Falied to eliminate through ERCP only
Key exclusion criteria (8 listed)
- Pregnancy
- Refusal of written informed consent
- Patients not suitable for ESWL/ Spyglass
- 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 |
|---|---|---|
| Spyglass-guided lithotripsyAlso: Direct vision systemSpyglass-guided lithotripsy | Procedure or surgery | Spyglass group |
| ESWLAlso: Lithotripsy through ESWLESWL+ERCP | Procedure or surgery | ESWL group |
Primary outcome
Technical success
Time frame: Intraoperative
Successfull intervention
Clinical success
Time frame: 1 month
Pancreatic duct stone clearance rate
3 secondary outcomes
Adverse events
Time frame: 1 month
Total number of ERCP
Time frame: 1 month
Procedure sessions
Time frame: 1 month
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 7 May 2026.
- Background: PubMed 34436824Guzman-Calderon E, Martinez-Moreno B, Casellas JA, Aparicio JR. Per-oral pancreatoscopy-guided lithotripsy for the endoscopic management of pancreatolithiasis: A systematic review and meta-analysis. J Dig Dis. 2021 Oct;22(10):572-581. doi: 10.1111/1751-2980.13041.
- Background: PubMed 34264399Bick BL, Patel F, Easler JJ, Tong Y, Watkins JL, McHenry L, Lehman G, Fogel EL, Gromski MA, Sherman S. A comparative study between single-operator pancreatoscopy with intraductal lithotripsy and extracorporeal shock wave lithotripsy for the management of large main pancreatic duct stones. Surg Endosc. 2022 May;36(5):3217-3226. doi: 10.1007/s00464-021-08631-7. Epub 2021 Jul 15.
- Results publication: PubMed 22110261Tandan M, Reddy DN. Extracorporeal shock wave lithotripsy for pancreatic and large common bile duct stones. World J Gastroenterol. 2011 Oct 21;17(39):4365-71. doi: 10.3748/wjg.v17.i39.4365.
- Results publication: PubMed 32743061van Huijgevoort NCM, Veld JV, Fockens P, Besselink MG, Boermeester MA, Arvanitakis M, van Hooft JE. Success of extracorporeal shock wave lithotripsy and ERCP in symptomatic pancreatic duct stones: a systematic review and meta-analysis. Endosc Int Open. 2020 Aug;8(8):E1070-E1085. doi: 10.1055/a-1171-1322. Epub 2020 Jul 21.
- Results publication: PubMed 28656688Beyna T, Neuhaus H, Gerges C. Endoscopic treatment of pancreatic duct stones under direct vision: Revolution or resignation? Systematic review. Dig Endosc. 2018 Jan;30(1):29-37. doi: 10.1111/den.12909. Epub 2017 Jul 27.
- 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, MD 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 Spyglass-guided lithotripsy and ESWL in people with Pancreatic Duct Stone, 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 2 inclusion and 8 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 7 May 2026. 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?
Technical success (time frame: Intraoperative). 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 NCT05475782, which also lists 5 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 7 May 2026.