EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis. (NCT03100578) | Clinical Trial Compass
CompletedNot Applicable
EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.
Spain99 participantsStarted 2017-06-27
Plain-language summary
Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis.
Spanish centers partners of the spanish society of digestive endoscopy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)