NCT07307248 To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage
| NCT ID | NCT07307248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | Walled Off Necrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 408 participants |
| Start Date | 2025-12-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 408 participants in total. It began in 2025-12-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Deepak L Jha, (Medical Gastroenterology)
PRINCIPAL INVESTIGATOR
Asian Institute of Gastroenterology, Hyderabad
Frequently Asked Questions
Who can join the NCT07307248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Walled Off Necrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07307248 currently recruiting?
Yes, NCT07307248 is actively recruiting participants. Contact the research team at drd55pakjha@gmail.com for enrollment information.
Where is the NCT07307248 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT07307248 clinical trial?
NCT07307248 is sponsored by Asian Institute of Gastroenterology, India. The principal investigator is Deepak L Jha, (Medical Gastroenterology) at Asian Institute of Gastroenterology, Hyderabad. The trial plans to enroll 408 participants.