Immediate necrosectomy vs. step-up approach after EUS-guided drainage of walled-off necrosis: a multicenter randomized controlled trial

Not Applicable

• Conditions: Symptomatic walled-off necrosis (WON); acute pancreatitis, walled-off necrosis, pancreatic fluid collection; D019283

• Registration Number: JPRN-jRCT1032220055
• Lead Sponsor: akai Yousuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 70

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

-WON inaccessible by EUS-guided approach
-WON with an indwelling AXIOS
-Severe coagulopathy; Platelet count <50,000/mm3 or PT-INR>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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tme to clinical success from randomization

Secondary Outcome Measures

Name	Time	Method
-Adverse event<br>-Mortality<br>-Technical success rate of initial EUS-PCD<br>-Incidence of biliary and gastrointestinal stricture<br>-Number and time of interventions<br>-Indwelling time of drainage of endoscopic and percutaneous drainage<br>-Success rate and procedure time for surgical procedures<br>-Hospital stay and ICU stay<br>-Duration of antibiotics administration<br>-Cost of interventions and hospital stay<br>-Recurence of WON<br>-Time to recurrence of WON<br>-Treatment duration of recurrent WON<br>-New onset of pseudocyst<br>-Treatment duration of new onset pseudocyst<br>-Incidence of new onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer<br>-The presence and time of medications for pancreatic exocrine insufficiency<br>-The presence and time of sarcopenia<br>-Morphological change of pancreas