EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis. (PROMETHEUS)
Pancreas Necrosis, Pancreatic Collection
About this trial
This is an interventional treatment trial for Pancreas Necrosis focused on measuring PANCREAS, ENDOSCOPIC INTERVENTION, PLASTIC STENT, SELF EXPANDING METALLIC STENT, ENDOSCOPIC TRANSMURAL DRAINAGE, WALLED OFF PANCREATIC NECROSIS
Eligibility Criteria
Inclusion Criteria:
- Age greater than or equal to 18 years
- Patient with indication (ASGE, Jacobson BC, GIE2005;) of pancreatic collection drainage type WALLED-OFF PANCREATIC NECROSIS * as a local complication of previous acute pancreatitis.
- Patient trained to understand and / or sign informed consent
- Patient who understands the type of study and will comply with all follow-up of complementary tests during its duration
Exclusion Criteria:
- Pregnancy or breastfeeding
- Severe coagulation disorder: INR> 1.5 not correctable with plasma and / or platelet administration <50,000 / mm3
- Asymptomatic patients, with no clinical indication of drainage, except for those with vascular involvement due to compression (eg stenosis, splenic vessels with collateral circulation, and risk of bleeding)
- Non-identification of solid content during the Endoscopic Ultrasound of the procedure
- No informed consent
- In the case of patients with mental retardation, without the ability to understand the nature and possible consequences of the study, except for the existence of a legal representative
- Patients unable to maintain posterior follow-up (lack of adherence)
- Situations that do not allow the practice of a high digestive endoscopy (eg, stenosis)
Sites / Locations
- Hospital Arnau de Vilanova
- Hospital Universitario Marqués de Valdecilla
- Hospital Costa del Sol
- Hospital San Juan de Dios
- Hospital Universitario Río Hortega
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario Ramón y Cajal
- Hospital Clínico San Carlos
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PLASTIC STENT
SELF EXPANDABLE METALLIC STENT
Endoscopic double pigtail plastic stent, with formal indication on pancreatic collection, according to the instruction forms of the manufacturer. Interventions associated: EUS-guided transmural drainage of pancretic collection: PLASTIC STENT.
Lumen apposing metal stent with formal indicaction on pancreatic collection, according to the manufacturer instruction forms. Interventions associated: EUS-guided transmural drainage of pancretic collection: METALLIC STENT.