Symptomatic walled-off necrosis (WON) acute pancreatitis, walled-off necrosis, pancreatic fluid collection
Conditions
Interventions
Patients are randomised to two groups bleow.
Immediate necrosectomy group: Endoscopic necrosectomy is performed at the same session of EUS-PCD.
Step-up approach group: Step-up intervention is performe
Endoscopic ultrasound-guided pancreatic drainage, endoscopic necrosectomy, EN, Step-up approach
Sponsors
Nakai Yousuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with WON accoring to the revised Atlanta classification -The long axis of WON is 4 cm or larger -At least one of four conditions; signs of infection, Gastrointestinal symptoms, abdominal symptoms, obstructive jaundice -Patients who need drainage of WON -Age of 18 years or older -Patients or their representative provide informed consent -Patients who visited or are hospitalized to the participating institutions
Exclusion criteria
Exclusion criteria: -WON inaccessible by EUS-guided approach -WON with an indwelling AXIOS -Severe coagulopathy; Platelet count 1,5 -Patients on antithrombotic agents which are unable to be stopped or modified according to the guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment -Patients who cannot tolerate endoscopic procedures safely -Pregnancy -Patients who are conidered as inappropriate for inclusion to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tme to clinical success from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| -Adverse event -Mortality -Technical success rate of initial EUS-PCD -Incidence of biliary and gastrointestinal stricture -Number and time of interventions -Indwelling time of drainage of endoscopic and percutaneous drainage -Success rate and procedure time for surgical procedures -Hospital stay and ICU stay -Duration of antibiotics administration -Cost of interventions and hospital stay -Recurence 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 time of medications for pancreatic exocrine insufficiency -The presence and time of sarcopenia -Morphological change of pancreas | — |
Contacts
Public ContactTomotaka Saito
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Outcome results
None listed