Clinical trial NCT05475782: Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones
Official title: Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pancreatic Duct Stone
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Technical success
timeFrame: Intraoperative
measure: Clinical success
timeFrame: 1 month
Secondary outcomes:
measure: Adverse events
timeFrame: 1 month
measure: Total number of ERCP
timeFrame: 1 month
measure: Procedure sessions
timeFrame: 1 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: Affilated Hangzhou First People Hospital
name: Jianfeng Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.