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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsian Institute of Gastroenterology, India

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Presence of chronic pancreatitis

Pancreatic malignancy (suspected or confirmed)

Incomplete endoscopic necrosectomy or persistent large necrotic debris on imaging at 2 weeks after drainage

Clinically significant bleeding

Trial design

Treatments tested in this trial

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

Treatment groups

408 Participants
are divided into 2 treatment groups