Pancreatic pseudocyst
Conditions
Interventions
Procedure/surgery
E01.370.350.850.280
Device
Control group: 21 volunteers of any gender and age with a pancreatic collection due to an episode of acute pancreatitis will be submitted to an endoscopic transmural drainage with a self-expandable me
Sponsors
Hospital das clínicas da Universidade de Sao Paulo
Hospital das clínicas da Universidade de Sao Paulo
Eligibility
Inclusion criteria
Inclusion criteria: Patients of any age; any gender; with the diagnosis of fluid pancreatic collection with definite ethiology of acute pancreatitis identified by abdominal radiological study after 4 weeks of onset of acute event; with symptoms such as pain or compression of the intra-abdominal organs by the collection or infected collections or causing sepsis
Exclusion criteria
Exclusion criteria: Patient who refuses to sign the informed consent;pancreatic fluid collection with less than 4 weeks after acute pancreatis;Cystic Formation less than 6 centimeters and without symptoms; food residues in the stomach during endoscopic exam;collection distant from the pancreas that prohibit endoscopic drainage because because it has no contact with the stomach or duodenum; evidence of bleeding inside of the collection; septic shock defined as an abdominal sepsis that does not respond to intravenous fluid and requires cardiac inotropic support or vasopressors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 It is expected that the migration rate of the fully covered self-expanding metal stents with anti-migration systems will be lower than stents without anti-migration system. Migration of the stent wil be verified during the endoscopic and/or radiologic exams. It is defined as displacement of the stent into the cyst or into the lumen of the gastrointestinal tract. We will observe the number and percentile of the migrated stents, which can occur right after intervention until its removal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2 Higher capability to access the collection through the stent to perform lavage and debriment with the stent with anti-migration system. The capability will be observed during the first procedure and subsequent exams. We will collect the number and the percentile of times that the event occured.;Expected outcome 3 Resolution of the collection observed in imaging exams at 1 to 3 months from the first intervention. The outcome will be verified with imaging exams with one to three months after inicial intervention. We will collect the number and the percentile of cases with complete, parcial and no resolution of the collection.;Expected outcome 4 It is expected the same incidence of recurrence of the pancreatic collections. Verified in computed tomography as new collection at the site of the drainage, five and eleven months after removal of the stent. We will collect the number of participants in which recurrence occured.;Expected outcome 5 Similar or slightly higher rate of adverse events related to the endoscopic procedures with stents with anti-migration systems: defined and classified according to consensus of the American Society of Gastrointestinal Endoscopy (published in 2010 by Peter Cotton). It is expected to be more correlated with the type and gravity of the collection. Data verified during the procedure, 24 hours, 7 days, 1 month and 3 months after. We will collect the number and the percentile of times that the event occured. | — |
Countries
Brazil
Contacts
Public ContactEduardo de Moura
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed