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

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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)

Locations

Other Locations

India

Asian Institute of Gastroenterology

RECRUITING

Hyderabad

Contact Information

Primary

Deepak L JHA, DrNB( medical gastroenterology

drd55pakjha@gmail.com

91-9967807858

Backup

Nitin G Jagtap, DNB (Medical Gastroenterology)

docnits13@gmail.com

+91-82859523

Time Frame

Start Date: 2025-12-25

Estimated Completion Date: 2028-12-31

Participants

Target number of participants: 408

Treatments

Experimental: Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement)

Participants in this arm will undergo early removal of the lumen-apposing metal stent (LAMS) at 2 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Following LAMS removal, a double-pigtail plastic stent (DPT) will be placed across the transmural tract to maintain drainage and reduce the risk of recurrent pancreatic fluid collection (PFC). Patients will undergo follow-up imaging at 3, 6, and 12 months to assess recurrence, complications, and need for reintervention.

Active_comparator: Standard Stent Replacement Arm (4-Week LAMS Removal without DPT)

Participants in this arm will undergo standard removal of the LAMS at 4 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Patients will be followed at 3, 6, and 12 months to assess recurrence of pancreatic fluid collection (PFC), complications, and reintervention rates.

Related Therapeutic Areas

Necrosis

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