Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones
Primary Purpose
Pancreatic Duct Stone
Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spyglass-guided lithotripsy
ESWL
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Duct Stone
Eligibility Criteria
Inclusion Criteria:
- Pancreatic duct sone
- Falied to eliminate through ERCP only
Exclusion Criteria:
- 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
Sites / Locations
- Hangzhou First People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Spyglass group
ESWL group
Arm Description
lithotripsy through Spyglass and ERCP
Lithotripsy through ESWL and ERCP
Outcomes
Primary Outcome Measures
Technical success
Successfull intervention
Clinical success
Pancreatic duct stone clearance rate
Secondary Outcome Measures
Adverse events
procedure related adverse events, bleeding, pancreatitis, etc
Total number of ERCP
Number of ERCPs performed for stone clearnce
Procedure sessions
Total sessions of therapy
Full Information
NCT ID
NCT05475782
First Posted
July 25, 2022
Last Updated
August 13, 2023
Sponsor
First People's Hospital of Hangzhou
1. Study Identification
Unique Protocol Identification Number
NCT05475782
Brief Title
Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones
Official Title
Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Duct Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spyglass group
Arm Type
Active Comparator
Arm Description
lithotripsy through Spyglass and ERCP
Arm Title
ESWL group
Arm Type
Experimental
Arm Description
Lithotripsy through ESWL and ERCP
Intervention Type
Procedure
Intervention Name(s)
Spyglass-guided lithotripsy
Other Intervention Name(s)
Direct vision system
Intervention Description
Spyglass-guided lithotripsy
Intervention Type
Procedure
Intervention Name(s)
ESWL
Other Intervention Name(s)
Lithotripsy through ESWL
Intervention Description
ESWL+ERCP
Primary Outcome Measure Information:
Title
Technical success
Description
Successfull intervention
Time Frame
Intraoperative
Title
Clinical success
Description
Pancreatic duct stone clearance rate
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Adverse events
Description
procedure related adverse events, bleeding, pancreatitis, etc
Time Frame
1 month
Title
Total number of ERCP
Description
Number of ERCPs performed for stone clearnce
Time Frame
1 month
Title
Procedure sessions
Description
Total sessions of therapy
Time Frame
1 month
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:
Pancreatic duct sone
Falied to eliminate through ERCP only
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Yang, MD
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
310006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34436824
Citation
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.
Results Reference
background
PubMed Identifier
34264399
Citation
Bick 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 Reference
background
PubMed Identifier
22110261
Citation
Tandan 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 Reference
result
PubMed Identifier
32743061
Citation
van 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 Reference
result
PubMed Identifier
28656688
Citation
Beyna 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.
Results Reference
result
Learn more about this trial
Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones
We'll reach out to this number within 24 hrs