Pancreatic Pseudocyst
Conditions
Interventions
The plastic stent group: Two (at least one) 7-Fr double pigtail stents will be placed. Following EUS guided puncture of a pseudocyst, a guidewire will be coiled within the lesion, and another guidewir
Boston Scientific Japan, Tokyo, Japan). A guidewire or dilator will be used if needed.
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with pancreatic pseudocyst defined by the revised Atlanta classification -The longest diameter of a targeted pseudocyst is more than 5 cm -Patients requiring drainage for symptoms associated with a pseudocyst -Patients aged 18 years or older -Written informed consent obtained from patients or their representatives
Exclusion criteria
Exclusion criteria: -A pseudocyst that is inaccessible via the EUS-guided approach -A plastic or lumen-apposing metal stent in situ -Coagulopathy (e.g., platelet count < 50,000/mm3 or prothrombin time international normalised ratio [PT-INR] >1.5) -Users of antithrombotic agents that cannot be discontinued according to the Japan Gastroenterological Endoscopy Society [JGES] guidelines -Patients who do not tolerate endoscopic procedures -Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success within 180 days of randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| -Adverse events -Mortality -Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage) -Incidence of biliary and gastrointestinal stricture -Number and time of interventions -Indwelling time of endoscopic and percutaneous drainage -Time to success -Success rate and operation time of surgical procedures -Hospital stay and ICU stay -Duration of antibiotics administration -Cost of interventions and hospital stay -Recurrence of WON -Time to recurrence of WON -Treatment duration of recurrent WON -New onset of pseudocyst -Treatment duration of new-onset pseudocyst -Incidence of new-onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer -The presence and timing of medications for pancreatic exocrine insufficiency -The presence and timing of sarcopenia -Morphological change of pancreas | — |
Countries
Japan
Contacts
Public ContactTomotaka Saito
Graduate School of Medicine, The University of Tokyo Department of Gastroenterology
Outcome results
None listed