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RecruitingNot ApplicableNCT07307248

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

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

Sponsor

Asian Institute of Gastroenterology, India

Enrollment

408 participants

Start Date

Dec 25, 2025

Study Type

INTERVENTIONAL

Conditions

Walled-off Necrosis

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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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Interventions

PROCEDUREStandard LAMS Removal with Double-Pigtail Plastic Stent

In the early stent removal arm, LAMS will be removed at 2 weeks followed by placement of a double-pigtail plastic stent (DPT).

PROCEDUREStandard LAMS Removal without DPT

In the standard arm, LAMS will be removed at 4 weeks.

Locations(1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

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NCT07307248

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