Walled Off NecrosisSTEP1NCT07307248
To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage
A study testing Standard LAMS Removal with Double-Pigtail Plastic Stent and Standard LAMS Removal without DPT in people with Walled Off Necrosis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Walled Off Necrosis
- What is being tested?
- Standard LAMS Removal with Double-Pigtail Plastic Stent and Standard LAMS Removal without DPT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteIndia
- Study dates
- 25 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
Deepak L JHA, Medical Gastroenterology, +91 9967807858, drd55pakjha@gmail.com
Nitin G Jagtap, Medical Gastroenterology), +91 82859523, docnits13@gmail.com
About this study
Official title: A Randomized Controlled Trial To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage.
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.
Read the 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.
- Conditions
- Walled Off Necrosis
- Being tested
- Standard LAMS Removal with Double-Pigtail Plastic Stent, Standard LAMS Removal without DPT
- Keywords
- Early LAMS removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard LAMS Removal with Double-Pigtail Plastic StentProcedure or surgery
Also called EARLY
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 DPTProcedure or surgery
In the standard arm, LAMS will be removed at 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement) | Experimental | Participants in this arm will undergo early removal of the lumen-apposing metal stent (LAMS) at 2 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Following LAMS removal, a double-pigtail plastic stent (DPT) will be placed across the transmural tract to maintain drainage and reduce the risk of recurrent pancreatic fluid collection (PFC). Patients will undergo follow-up imaging at 3, 6, and 12 months to assess recurrence, complications, and need for reintervention. Receives: Procedure: Standard LAMS Removal with Double-Pigtail Plastic Stent |
| Standard Stent Replacement Arm (4-Week LAMS Removal without DPT) | Active comparator | Participants in this arm will undergo standard removal of the LAMS at 4 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Patients will be followed at 3, 6, and 12 months to assess recurrence of pancreatic fluid collection (PFC), complications, and reintervention rates. Receives: Procedure: Standard LAMS Removal without DPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after initial drainage procedure
Secondary outcomes (3)
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.
Measured: 3 months and 6 months after the initial drainage procedure
Stent-Related Adverse Events
Incidence of complications directly related to LAMS or DPT placement, including migration, occlusion, infection, or buried stent syndrome.
Measured: Up to 12 months post-procedure
Need for Reinterventions
Proportion of patients requiring additional interventions for pancreatic collection management, such as repeat endoscopic drainage, necrosectomy, percutaneous drainage or surgical necrosectomy.
Measured: Within 12 months after stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start25 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Walled Off NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Deepak L Jha, (Medical Gastroenterology), Principal investigator, Asian Institute of Gastroenterology, Hyderabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307248
- Sponsor's protocol ID
- STEP1
- Acronym
- STEP1
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because data sharing is not planned for this study.
Publications
Zeng Y, Yang J, Zhang JW. Endoscopic transluminal drainage and necrosectomy for infected necrotizing pancreatitis: Progress and challenges. World J Clin Cases. 2023 Mar 26;11(9):1888-1902. doi: 10.12998/wjcc.v11.i9.1888.
PubMed 36998953
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage.
- ClinicalTrials.gov ID
- NCT07307248
- Acronym / sponsor ID
- STEP1 / STEP1
- Conditions
- Walled Off Necrosis
- Keywords
- Early LAMS removal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement) | Experimental | Procedure: Standard LAMS Removal with Double-Pigtail Plastic StentParticipants in this arm will undergo early removal of the lumen-apposing metal stent (LAMS) at 2 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Following LAMS removal, a double-pigtail plastic stent (DPT) will be placed across the transmural tract to maintain drainage and reduce the risk of recurrent pancreatic fluid collection (PFC). Patients will undergo follow-up imaging at 3, 6, and 12 months to assess recurrence, complications, and need for reintervention. |
| Standard Stent Replacement Arm (4-Week LAMS Removal without DPT) | Active comparator | Procedure: Standard LAMS Removal without DPTParticipants in this arm will undergo standard removal of the LAMS at 4 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Patients will be followed at 3, 6, and 12 months to assess recurrence of pancreatic fluid collection (PFC), complications, and reintervention rates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard LAMS Removal with Double-Pigtail Plastic StentAlso: EARLYIn the early stent removal arm, LAMS will be removed at 2 weeks followed by placement of a double-pigtail plastic stent (DPT). | Procedure or surgery | Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement) |
| Standard LAMS Removal without DPTIn the standard arm, LAMS will be removed at 4 weeks. | Procedure or surgery | Standard Stent Replacement Arm (4-Week LAMS Removal without DPT) |
Primary outcome
Recurrence of Pancreatic Fluid Collection (PFC)
Time frame: 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.
3 secondary outcomes
Recurrence of Pancreatic Fluid Collection at 3 and 6 Months
Time frame: 3 months and 6 months after the initial drainage procedure
Stent-Related Adverse Events
Time frame: Up to 12 months post-procedure
Need for Reinterventions
Time frame: Within 12 months after stent removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Results publication: PubMed 36998953Zeng Y, Yang J, Zhang JW. Endoscopic transluminal drainage and necrosectomy for infected necrotizing pancreatitis: Progress and challenges. World J Clin Cases. 2023 Mar 26;11(9):1888-1902. doi: 10.12998/wjcc.v11.i9.1888.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because data sharing is not planned for this study.
Related trials for Walled Off Necrosis
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Recruiting
The Effect of Proton Pump Inhibitors(PPIs) on Endoscopic Treatment of Walled-off Necrosis (WON)
Pancreatic Walled-off Necrosis
Recruiting
Necrosectomy With Cryotechnology for Accelerated Removal
Pancreatic Necrosis, Acute Pancreatitis
Recruiting
Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis
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Recruiting
Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis
Acute Necrotizing Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deepak L Jha, (Medical Gastroenterology) principal investigator
Asian Institute of Gastroenterology, Hyderabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard LAMS Removal with Double-Pigtail Plastic Stent and Standard LAMS Removal without DPT in people with Walled Off Necrosis, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepak L JHA, DrNB( medical gastroenterology (91-9967807858, drd55pakjha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Pancreatic Fluid Collection (PFC) (time frame: 12 months after initial drainage procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07307248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.