Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention (NCT05307861) | Clinical Trial Compass
UnknownNot Applicable
Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention
Ecuador98 participantsStarted 2022-02-01
Plain-language summary
Multiple risk factors have been linked with post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP); therefore, it is critical to follow strategies to reduce associated risk, morbidity, and mortality. However, there are also factors, such as pancreatic duct stenting, which have shown evidence of PEP prevention. The investigators pursue to compare plastic vs biodegradable pancreatic stents in the prevention of PEP.
Who can participate
Age range
18 Years – 99 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:
* Patient is scheduled for ERCP
* Patient is 18 years old or older
* Biliary tract disease presence
* Non-manipulated pancreatic papilla
* Written informed consent provided
Exclusion Criteria:
* Patient not requiring pancreatic stenting during ERCP
* Failed pancreatic stent placement
* Patients at risk of fluid overload
* Patients with cholangitis, sepsis, acute/flared up chronic pancreatitis
* Recent previous biliary tract manipulation (i.e., pancreatoscopy, wirsungoscopy, etc.)
* Hemodynamic instability
* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with a meaningful impact on cardiac risk assessment (NHYA III/IV)
* Pregnancy or nursing
* Refuse to participate in the study or to sign corresponding informed consent
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
PEP prevention at 72 hours
Timeframe: up to 72 hours after randomization
Trial details
NCT IDNCT05307861
SponsorInstituto Ecuatoriano de Enfermedades Digestivas