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Clinical Trials in India / NCT07307248
Recruiting Not applicable

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

NCT07307248 · tracked via the Priya Life Science India tracker
Sponsor
Asian Institute of Gastroenterology, India
Phase
Not applicable
Started
2025-12-25
Last updated
2026-01-28

Condition(s) studied

Walled Off Necrosis

Investigational drug(s) / intervention(s)

Standard LAMS Removal with Double-Pigtail Plastic StentStandard LAMS Removal without DPT

Standard 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).

Standard LAMS Removal without DPT: In the standard arm, LAMS will be removed at 4 weeks.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Recurrence of Pancreatic Fluid Collection (PFC) — 12 months after initial drainage procedure
    Recurrence is defined as the redevelopment of a symptomatic pancreatic fluid collection confirmed on imaging (CT or MRI) after initial resolution following endoscopic drainage and lumen-apposing metal stent (LAMS) removal. The recurrence rate will be compared between the early LAMS removal + double-pigtail plastic stent (DPT) group and the standard 4-week LAMS removal group.

Trial sites (1)

FacilityCityRegionStatus
Asian Institute of Gastroenterology Hyderabad Telangana Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07307248 on ClinicalTrials.gov ↗ ← All trials in India