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

NCT07307248 | Recruiting DMC

• 1 other identifier: STEP1
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Walled Off Necrosis

Keywords

Early LAMS removal

Outcome Measures

Primary Outcomes (1)

• Recurrence of Pancreatic Fluid Collection (PFC)

  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.

  12 months after initial drainage procedure

Secondary Outcomes (3)

• Recurrence of Pancreatic Fluid Collection at 3 and 6 Months

  3 months and 6 months after the initial drainage procedure

• Stent-Related Adverse Events

  Up to 12 months post-procedure

• Need for Reinterventions

  Within 12 months after stent removal

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: Standard LAMS Removal with Double-Pigtail Plastic Stent

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

ACTIVE COMPARATOR

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.

Procedure: Standard LAMS Removal without DPT

Interventions

Standard LAMS Removal with Double-Pigtail Plastic Stent PROCEDURE

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

Also known as: EARLY

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

Standard LAMS Removal without DPT PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

RECRUITING

Related Publications (1)

• Zeng Y, Yang J, Zhang JW. Endoscopic transluminal drainage and necrosectomy for infected necrotizing pancreatitis: Progress and challenges. World J Clin Cases. 2023 Mar 26;11(9):1888-1902. doi: 10.12998/wjcc.v11.i9.1888.

  PMID: 36998953 RESULT

Study Officials

• Deepak L Jha, (Medical Gastroenterology)

  Asian Institute of Gastroenterology, Hyderabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepak L JHA, DrNB( medical gastroenterology

CONTACT

91-9967807858; drd55pakjha@gmail.com

Nitin G Jagtap, DNB (Medical Gastroenterology)

CONTACT

+91-82859523; docnits13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR , INTERVENTIONAL ENDOSCOPY

Model Details: Two-arm parallel randomized controlled trial comparing early (2-week) versus standard (4-week) LAMS removal strategies in patients with walled-off pancreatic necrosis (WON).

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)