Status:
UNKNOWN
Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis
Lead Sponsor:
Evangelisches Krankenhaus Düsseldorf
Conditions:
Pancreatitis, Calcific
Pancreatitis, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
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 panc...
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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04131010
Start Date
May 31 2019
End Date
December 1 2022
Last Update
October 29 2019
Active Locations (1)
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1
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40217