Walled Off Necrosis
Conditions
Keywords
Early LAMS removal
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.
Detailed description
Management of walled-off pancreatic necrosis (WON) following acute pancreatitis has been transformed by the use of endoscopic ultrasound (EUS)-guided transluminal drainage with a lumen-apposing metal stent (LAMS). The LAMS provides a large-caliber conduit for drainage and allows for direct endoscopic necrosectomy, leading to faster resolution of collections and reduced need for surgical intervention. However, the optimal timing for LAMS removal remains uncertain. Prolonged retention of LAMS has been associated with several adverse events, including delayed bleeding due to vascular erosion, buried-stent syndrome, stent migration, and tissue hyperplasia at the tract site. Conversely, premature removal of the stent may lead to incomplete drainage, persistent or recurrent pancreatic fluid collections (PFCs), and the need for repeat interventions. Therefore, determining the ideal balance between minimizing stent-related complications and preventing recurrence is a key clinical challenge. Early removal of the LAMS-either 2 weeks after insertion or immediately after the last necrosectomy session-may reduce the risk of delayed bleeding and other metal stent-related complications. However, to maintain tract patency and allow residual drainage, placement of a prophylactic double-pigtail plastic stent (DPT) at the time of LAMS removal has been proposed. The DPT provides a smaller but stable drainage channel that may prevent premature tract closure and recurrence of fluid collections. This randomized controlled trial aims to rigorously test whether early LAMS removal combined with DPT placement offers better long-term outcomes compared to standard 4-week LAMS removal without DPT. The results are expected to provide evidence-based guidance on optimizing stent management in patients with WON undergoing endoscopic necrosectomy, balancing efficacy with safety.
Interventions
PROCEDUREStandard LAMS Removal with Double-Pigtail Plastic Stent
In the early stent removal arm, LAMS will be removed at 2 weeks followed by placement of a double-pigtail plastic stent (DPT).
PROCEDUREStandard LAMS Removal without DPT
In the standard arm, LAMS will be removed at 4 weeks.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Pancreatic Fluid Collection (PFC) | 12 months after initial drainage procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Pancreatic Fluid Collection at 3 and 6 Months | 3 months and 6 months after the initial drainage procedure | 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. |
| Stent-Related Adverse Events | Up to 12 months post-procedure | Incidence of complications directly related to LAMS or DPT placement, including migration, occlusion, infection, or buried stent syndrome. |
| Need for Reinterventions | Within 12 months after stent removal | Proportion of patients requiring additional interventions for pancreatic collection management, such as repeat endoscopic drainage, necrosectomy, percutaneous drainage or surgical necrosectomy. |
Countries
India
Contacts
CONTACTDeepak L JHA, DrNB( medical gastroenterology
CONTACTNitin G Jagtap, DNB (Medical Gastroenterology)
PRINCIPAL_INVESTIGATORDeepak L Jha, (Medical Gastroenterology)
Asian Institute of Gastroenterology, Hyderabad
Outcome results
None listed