NCT04131010

Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Evangelisches Krankenhaus Düsseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigation of the efficacy and safety of digital catheter-based pancreatoscopy (DCP) for the Treatment of symptomatic Stones of the pancreatic duct in selected patients with chronic calcifying pancreatitis (CCP)

Detailed description

Background Endoscopic treatment of patients with chronic calcifying pancreatitis (CCP) is still challenging and controversially discussed. The goal is symptom control and relief of pain, which can be achieved by draining an obstructed main pancreatic duct (MPD) and/or removal of ductal stones. The 2012 European Society of Gastrointestinal Endoscopy (ESGE)- Guidelines recommends ESWL as a first step for patients with uncomplicated painful chronic pancreatitis and radiopaque stones ≥5mm obstructing the MPD. However, limitations of ESWL (extracorporeal shockwave lithotripsy ) include its limited availability, a likely need for multiple sessions and often repeated ERCP (endoscopic retrograde cholangiopancreatography) sessions for removal of stone fragments or treatment of associated strictures. Pancreatoscopically guided management of pancreatic stones offers a potential alternative to ESWL. However, the numbers of studies and enrolled patients are still low. In 2015 single operator video cholangioscopy (SpyGlassDS, Boston Scientific) was introduced. Available data on its use for pancreatoscopy is limited. The technique provides digital imaging with a higher resolution and improved maneuverability compared to the legacy fiberoptic system. In addition, the working channel was enlarged to a diameter of 1.3 mm. Although SOVP have shown promise in CCP, studies to date generally have been limited by: retrospective design, relatively small and mixed patient populations, short follow-up periods, different clinical and technical endpoints, and, often, a single-center design. Therefore, the investigators designed a prospective multicenter cohort study to evaluate long-term clinical efficacy, technical success and safety of SOVP.

Conditions

• Pancreatitis, Calcific
• Pancreatitis, Chronic

Interventions

Type	Name	Description
DEVICE	single operator video cholangioscopy	The technique provides digital imaging with a higher resolution and improved maneuverability compared to the legacy fiberoptic system. In addition, the working channel was enlarged to a diameter of 1.3 mm. Retrospective data showed an overall technical success rate for single-operator video pancreatoscopy (SOVP) guided treatment of pancreatic stones of 95%

Timeline

• Start date: 2019-05-31
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-10-18
• Last updated: 2019-10-29

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study