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

NCT ID: NCT04131010

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SpyGlass Pancreatoscopy

ERP with direct pancreatoscopy

Group Type: EXPERIMENTAL

single operator video cholangioscopy

Intervention Type: DEVICE

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%

Interventions

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%

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Eligible patients are adults (≥ 18 years of age) with a signed informed consent with:
• symptomatic chronic pancreatitis (recurrent pain attacks, history of pain for at least 3 months), and
• ≤3 radiopaque stones ≥5mm obstructing the MPD in the pancreatic head and/or corpus.

Exclusion Criteria

• - Health status ASA 4
• Pregnancy
• Coagulopathy (INR≥2.0, Platelets < 70/nl)
• Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
• Any medical contraindication to ERCP, deep sedation or general anesthesia
• History of chronic symptomatic pancreatitis of more than 3-4 years[9]
• History of daily use of opioids except Tramadol for more than 6 months in the last 2 years
• Episode of biliary obstruction in the previous 2 months (defined as jaundice or bilirubin levels >=2,5mg/dl or CBD stent
• Auto-Immune Pancreatitis or IgG4 associated pancreatitis
• Altered GI anatomy, previous failures of endoscopic approach to the papilla
• Abdominal pain not attributable to CP
• Any suspicion of pancreatic cancer
• Current symptomatic WON
• More than one ductal stricture in the pancreatic head or body
• Previous ESWL pancreatic stones
• Age <18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evangelisches Krankenhaus Düsseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christian Gerges, Dr.

Role: CONTACT

Christian.Gerges@evk-duesseldorf.de

+49 211 919 1605

Torsten Beyna, Dr.

Role: CONTACT

Torsten.Beyna@evk-duesseldorf.de

+49 211 919 1605

Facility Contacts

Christian Gerges, Dr.

Role: primary

Christian.Gerges@evk-duesseldorf.de

+49 211 919 1605

Other Identifiers

SPYGlass DS

Identifier Type: -

Identifier Source: org_study_id