NCT04115826

ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis

Per-oral Pancreatoscopy-guided Lithotripsy vs. Extracorporeal Shock Wave Lithotripsy in Chronic Pancreatitis

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatitis, Chronic

Interventions

Type	Name	Description
PROCEDURE	Per-oral Pancreatoscopy-guided Lithotripsy	Per-oral Pancreatoscopy-guided lithotripsy will be administered for a maximum of 4 sessions (1 hour max per session). Either electrohydraulic lithotripsy or laser lithotripsy will be allowed during the session at the discretion of the endoscopist.
PROCEDURE	Extracorporeal Shock-Wave Lithotripsy	ESWL will then be performed with the patient in either slight left or right lateral decubitus with shock waves entering the body from the ventral side. The shockwaves will be focused first on the most distally located stone within the main duct and then on other calculi moving from the head towards the body. If a stent has been inserted during preceding ERP then this may also serve as a guide to target main pancreatic duct stones by ESWL. A total of one hour of ESWL at a rate of 60-120 shocks/minute will be delivered in one treatment session.

Timeline

• Start date: 2020-01-02
• Primary completion: 2025-03-31
• Completion: 2026-06-30
• First posted: 2019-10-04
• Last updated: 2024-05-22

Locations

1 site across 1 country: United States