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

Evangelisches Krankenhaus Düsseldorf

Status

Unknown

Conditions

Pancreatitis, Calcific

Pancreatitis, Chronic

Treatments

Device: single operator video cholangioscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04131010

SPYGlass DS

Details and patient eligibility

About

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)

Full 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.

Enrollment

43 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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