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 range18 Years – 99 Years

SexALL

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

What they're measuring

PEP prevention at 72 hours

Timeframe: up to 72 hours after randomization

Trial details

NCT IDNCT05307861

SponsorInstituto Ecuatoriano de Enfermedades Digestivas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Biliary Tract Diseases trials