NCT05475782

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

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
unknown

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
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

July 25, 2022

Last Update Submit

August 13, 2023

Conditions

Pancreatic Duct Stone

Outcome Measures

Primary Outcomes (2)

  • Technical success

    Successfull intervention

    Intraoperative

  • Clinical success

    Pancreatic duct stone clearance rate

    1 month

Secondary Outcomes (3)

  • Adverse events

    1 month

  • Total number of ERCP

    1 month

  • Procedure sessions

    1 month

Study Arms (2)

Spyglass group

ACTIVE COMPARATOR

lithotripsy through Spyglass and ERCP

Procedure: Spyglass-guided lithotripsy

ESWL group

EXPERIMENTAL

Lithotripsy through ESWL and ERCP

Procedure: ESWL

Interventions

Spyglass-guided lithotripsyPROCEDURE

Spyglass-guided lithotripsy

Also known as: Direct vision system
Spyglass group
ESWLPROCEDURE

ESWL+ERCP

Also known as: Lithotripsy through ESWL
ESWL group

Eligibility Criteria

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

You may qualify if:

  • Pancreatic duct sone
  • Falied to eliminate through ERCP only

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (5)

  • 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.

    PMID: 34436824BACKGROUND

  • 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.

    PMID: 34264399BACKGROUND

  • 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.

    PMID: 22110261RESULT

  • 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.

    PMID: 32743061RESULT

  • 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.

    PMID: 28656688RESULT

Study Officials

  • Jianfeng Yang, MD

    Affilated Hangzhou First People Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
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

July 25, 2022

First Posted

July 27, 2022

Study Start

January 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)