Tokyo, Aug. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058676) titled 'A multicenter randomized controlled trial comparing EUS-guided drainage strategies for necrotizing pancreatitis after acute pancreatitis (WONDER-03 study)' on Aug. 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - The University of Tokyo

Condition: Condition - Necrotizing pancreatitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare outcomes of EUS-guided drainage performed after encapsulation versus before encapsulation in patients with necrotizing pancreatitis Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Imaging preferably contrast-enhanced CT is performed every 7-10 days to assess the degree of encapsulation EUS-guided drainage is performed when >=80 percent encapsulation is confirmed and the patient is symptomatic The procedure is conducted within 72 hours after the latest imaging A single LAMS is placed and a nasocystic drain is generally added If no improvement is observed step-up interventions such as endoscopic necrosectomy or additional drainage are performed within 24-96 hours Consultation with the expert panel is conducted as needed. Interventions/Control_2 - EUS-guided drainage is performed at 4-5 weeks preferably 4 weeks after the onset of acute pancreatitis if the patient is symptomatic Imaging preferably contrast-enhanced CT is conducted and drainage is performed within 72 hours of the latest imaging A single LAMS is placed and a nasocystic drain is generally added If there is no improvement step-up interventions are performed within 24-96 hours If conservative therapy fails due to severe inflammation earlier intervention before 4 weeks is permitted with expert panel consultation as necessary.

Eligibility: Age-lower limit - 18 years-old =18 years at the time of consent; no restriction on sex 4. Provided written informed consent by the subject or legally authorized representative after sufficient explanation of the study 5. Currently hospitalized or receiving outpatient care at a participating study center Key exclusion criteria - 1. Unknown onset date** of acute pancreatitis 2. Already received transmural drainage stent placement for necrotizing pancreatitis 3. Diagnosed with chronic pancreatitis 4. Deemed ineligible for safe endoscopic treatment by the investigator 5. Pregnant at the time of enrollment 6. Judged by the principal or sub-investigator to be inappropriate for inclusion Target Size - 214

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 28 Day Anticipated trial start date - 2025 Year 08 Month 11 Day Last follow-up date - 2034 Year 07 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067083

Disclaimer: Curated by HT Syndication.