Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04115826
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-22
First Post:
2019-10-02
Brief Title:
ESWL vs Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Per-oral Pancreatoscopy-guided Lithotripsy vs Extracorporeal Shock Wave Lithotripsy in Chronic Pancreatitis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center randomized controlled trial comparing extracorporeal shock-wave lithotripsy ESWL with per-oral pancreatoscopy-guided lithotripsy PPL in the treatment of patients with chronic pancreatitis and refractory main pancreatic duct stones This study will be comparing the two treatment options for patients who have stones that fail initial endoscopic therapy via endoscopic retrograde pancreatography ERCP The study will look at the stone clearance rates and patient-centered outcomes including quality of life and pain
Detailed Description:
Patients with chronic pancreatitis frequently develop obstructing pancreatic duct stones which can lead to severe pain Current standard methods to remove these stones include ERCP and extracorporeal shock-wave lithotripsy ESWL which are limited in removing larger and multiple impacted stones Availability in the USA of ESWL for this indication also may be limited even at major referral centers The introduction of single-operator per-oral pancreatoscopy SpyGlassTM has enabled direct intraductal visualization to target stones Retrospective studies demonstrate a high success rate but literature is quite limited uncontrolled and highly selective Further many experts and recent European Society Guidelines suggest that ESWL is the only primary therapy for larger stones 5mm or larger and that intraductal endoscopy and lithotripsy should only be used for salvage therapy in select patients
A critical need exists to compare the efficacy of per oral pancreatoscopy-guided lithotripsy PPL with ESWL to determine which therapy is most efficacious in removing refractory PD stones The investigators believe ERCP with POP has distinct advantages of localizing shocks to the stones helping to identify and treat underlying strictures in the duct and lithotripsy of multiple stones can be performed at a single session with a recent multi-center international retrospective study showing all stones removed in a single session in over 70 of cases Therefore this project seeks to change the perceived standard of care as it relates to symptomatic pancreatic duct stones in this population shifting the pendulum towards endoscopic and specifically pancreatoscopy-guided therapy
A critical need exists to compare the efficacy of per oral pancreatoscopy-guided lithotripsy PPL with ESWL to determine which therapy is most efficacious in removing refractory PD stones The investigators believe ERCP with POP has distinct advantages of localizing shocks to the stones helping to identify and treat underlying strictures in the duct and lithotripsy of multiple stones can be performed at a single session with a recent multi-center international retrospective study showing all stones removed in a single session in over 70 of cases Therefore this project seeks to change the perceived standard of care as it relates to symptomatic pancreatic duct stones in this population shifting the pendulum towards endoscopic and specifically pancreatoscopy-guided therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None