Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic D… (NCT04131010) | Clinical Trial Compass
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Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis
Germany43 participantsStarted 2019-05-31
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Number of participants with complete clearance of the MPD from ≤3 stones in the pancreatic head and/or body by means of SOVP in ≤3 treatment sessions