Early (2-week) versus standard (4-week) metal stent removal after EUS-guided drainage for walled-off pancreatic necrosis.
A Randomized Controlled Trial To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage.
This test checks whether removing the metal stent early (at 2 weeks) and placing a double-pigtail plastic drain, versus removing it at the usual 4 weeks without a plastic drain, lowers the chance of fluid collection coming back or needing another procedure in adults with walled-off pancreatic necrosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 408 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT07307248 on ClinicalTrials.gov |
What this trial studies
In adults with walled-off pancreatic necrosis who undergo EUS-guided transluminal drainage with a lumen-apposing metal stent (LAMS) and show ≥70% radiologic resolution at 2 weeks, the trial compares early LAMS removal with placement of a double-pigtail plastic stent (DPT) to standard LAMS removal at 4 weeks without DPT. Participants receive endoscopic management per protocol and are followed for 12 months for pancreatic fluid collection (PFC) recurrence, need for reintervention, and stent-related adverse events. Key monitored complications include bleeding, infection requiring intervention, stent migration, and tissue hyperplasia at the tract. The aim is to find a timing strategy that minimizes metal stent–related harms while preserving adequate drainage and minimizing recurrence.
Who should consider this trial
Good fit: Adults (≥18 years) with WON treated by EUS-guided LAMS drainage who have ≥70% radiologic resolution at 2 weeks, no chronic pancreatitis or suspected/confirmed pancreatic malignancy, and no major procedure-related complications in the first 2 weeks are ideal candidates.
Not a fit: Patients with chronic pancreatitis, suspected pancreatic cancer, incomplete necrosectomy or persistent large necrotic debris at 2 weeks, or those who had major early complications are unlikely to benefit from the early-removal approach.
Why it matters
Potential benefit: If successful, early LAMS removal with a DPT could reduce bleeding and other metal stent–related complications while maintaining low recurrence and reintervention rates.
How similar studies have performed: Small observational and prospective series suggest shorter LAMS dwell time may reduce stent-related adverse events and that DPT placement can preserve tract patency, but high-quality randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hyderabad, Telangana
- Asian Institute of Gastroenterology — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Principal investigator: Deepak L Jha, (Medical Gastroenterology) — Asian Institute of Gastroenterology, Hyderabad
- Study coordinator: Deepak L JHA, DrNB( medical gastroenterology
- Email: drd55pakjha@gmail.com
- Phone: 91-9967807858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.