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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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