Early (2-week) versus standard (4-week) metal stent removal after EUS-guided drainage for walled-off pancreatic necrosis.
Official title: A Randomized Controlled Trial To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage.
Run by Asian Institute of Gastroenterology, India · NCT07307248 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 408 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Status | Recruiting |
| Started | December 25, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07307248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing immediate necrosectomy to a step-up approach for treating walled-off necrosis
This study is testing whether a quick procedure to remove walled-off necrosis can help people with symptoms from acute pancreatitis recover faster than the usual step-by-step treatment.
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Nasojejunal versus oral feeding after endoscopic drainage of walled-off pancreatic necrosis
This will see if feeding through a tube into the small intestine (nasojejunal feeding) works better than eating by mouth for adults undergoing endoscopic drainage of walled-off pancreatic necrosis.
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Cryotechnology for removing necrotic pancreatic tissue
This study is testing a new freezing technique to see if it can help doctors remove dead tissue from the pancreas more effectively in patients with severe pancreatitis.
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Does giving PPIs after endoscopic draining of pancreatic walled-off necrosis change how treatment proceeds?
This trial tests whether continuing proton pump inhibitors after an endoscopic procedure for pancreatic walled-off necrosis helps or hinders treatment, compared with not using PPIs.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.