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

ConditionWalled Off Necrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsian Institute of Gastroenterology, India

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Presence of chronic pancreatitis

Pancreatic malignancy (suspected or confirmed)

Incomplete endoscopic necrosectomy or persistent large necrotic debris on imaging at 2 weeks after drainage

Clinically significant bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard LAMS Removal with Double-Pigtail Plastic Stent

    Procedure/Surgery

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

  • Standard LAMS Removal without DPT

    Procedure/Surgery

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

Treatment groups

408 Participants
are divided into 2 treatment groups
Group A: Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement)Experimental treatment 1 intervention
Group B: Standard Stent Replacement Arm (4-Week LAMS Removal without DPT)Active comparator 1 intervention

Trial outcomes

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.

Time frame
12 months after initial drainage procedure

Secondary outcomes

1

Recurrence of Pancreatic Fluid Collection at 3 and 6 Months

Incidence of PFC recurrence confirmed by imaging (CT/MRI) or symptomatic relapse within 3 and 6 months of the index drainage procedure. Comparison will be made between the early LAMS removal + DPT group and the standard 4-week LAMS removal group.

Time frame
3 months and 6 months after the initial drainage procedure
2

Stent-Related Adverse Events

Incidence of complications directly related to LAMS or DPT placement, including migration, occlusion, infection, or buried stent syndrome.

Time frame
Up to 12 months post-procedure
3

Need for Reinterventions

Proportion of patients requiring additional interventions for pancreatic collection management, such as repeat endoscopic drainage, necrosectomy, percutaneous drainage or surgical necrosectomy.

Time frame
Within 12 months after stent removal

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asian Institute of Gastroenterology, India

Lead sponsor

Source ClinicalTrials.gov
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