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To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage

RecruitingNAAges 18 Years - anyAllAsian Institute of Gastroenterology, India
NCT07307248 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In adults with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound (EUS)-guided transluminal necrosectomy, does early removal of the lumen-apposing metal stent (LAMS) (at 2 weeks or immediately after the last necrosectomy) with placement of a double-pigtail plastic stent (DPT), compared to delayed LAMS removal at 4 weeks without a DPT, result in a lower rate of pancreatic fluid collection (PFC) recurrence or need for reintervention over 12 months.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Patients with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound-guided drainage with lumen-apposing metal stent (LAMS) * Radiological resolution of the pancreatic fluid collection ≥70% at 2 weeks after index endoscopic drainage, assessed on cross-sectional imaging (CT or MRI) Exclusion Criteria: * Presence of chronic pancreatitis * Pancreatic malignancy (suspected or confirmed) * Incomplete endoscopic necrosectomy or persistent large necrotic debris on imaging at 2 weeks after drainage * Occurrence of major procedure-related adverse events within the first 2 weeks, including: * Clinically significant bleeding * Infection requiring additional intervention * Stent migration * Inability or unwillingness to provide written informed consent
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What it tests

  • Standard LAMS Removal with Double-Pigtail Plastic Stent
  • Standard LAMS Removal without DPT
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Where

1 site
Asian Institute of Gastroenterology
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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