Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis

Summary

Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.

Eligibility

Inclusion Criteria:

* Patients with WON defined according to the revised Atlanta classification
* The longest diameter of WON is 4 cm or larger
* Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
* Patients who need drainage for WON
* Age of 18 years or older
* Patients or their representatives provide informed consent
* Patients who visit or are hospitalized at the participating institutions

Exclusion Criteria:

* WON inaccessible by EUS-guided approach
* AXIOS stent has already been placed into the WON prior to the enrollment
* Severe coagulopathy; Platelet count \< 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) \>1.5
* Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)"
* Patients who cannot tolerate endoscopic procedures
* Pregnant women
* Patients considered inappropriate for inclusion by investigators

Conditions5

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