NCT07307248

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Management of walled-off pancreatic necrosis (WON) following acute pancreatitis has been transformed by the use of endoscopic ultrasound (EUS)-guided transluminal drainage with a lumen-apposing metal stent (LAMS). The LAMS provides a large-caliber conduit for drainage and allows for direct endoscopic necrosectomy, leading to faster resolution of collections and reduced need for surgical intervention. However, the optimal timing for LAMS removal remains uncertain. Prolonged retention of LAMS has been associated with several adverse events, including delayed bleeding due to vascular erosion, buried-stent syndrome, stent migration, and tissue hyperplasia at the tract site. Conversely, premature removal of the stent may lead to incomplete drainage, persistent or recurrent pancreatic fluid collections (PFCs), and the need for repeat interventions. Therefore, determining the ideal balance between minimizing stent-related complications and preventing recurrence is a key clinical challenge. Early removal of the LAMS-either 2 weeks after insertion or immediately after the last necrosectomy session-may reduce the risk of delayed bleeding and other metal stent-related complications. However, to maintain tract patency and allow residual drainage, placement of a prophylactic double-pigtail plastic stent (DPT) at the time of LAMS removal has been proposed. The DPT provides a smaller but stable drainage channel that may prevent premature tract closure and recurrence of fluid collections. This randomized controlled trial aims to rigorously test whether early LAMS removal combined with DPT placement offers better long-term outcomes compared to standard 4-week LAMS removal without DPT. The results are expected to provide evidence-based guidance on optimizing stent management in patients with WON undergoing endoscopic necrosectomy, balancing efficacy with safety.

Conditions

• Walled Off Necrosis

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	Standard LAMS Removal without DPT	In the standard arm, LAMS will be removed at 4 weeks.

Timeline

• Start date: 2025-12-25
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-12-29
• Last updated: 2026-01-28

Locations

1 site across 1 country: India