To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage (STEP1)

January 27, 2026 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, India

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Deepak L JHA, DrNB( medical gastroenterology
  • Phone Number: 91-9967807858
  • Email: drd55pakjha@gmail.com

Study Contact Backup

  • Name: Nitin G Jagtap, DNB (Medical Gastroenterology)
  • Phone Number: +91-82859523
  • Email: docnits13@gmail.com

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Asian Institute Of Gastroenterology
        • Contact:
        • Contact:
          • Nitin G Jagtap, Medical Gastroenterology)
          • Phone Number: +91 82859523
          • Email: docnits13@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement)
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.
Procedure: Standard 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).
Other Names:
  • EARLY
Active Comparator: Standard Stent Replacement Arm (4-Week LAMS Removal without DPT)
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.
Procedure: Standard LAMS Removal without DPT
In the standard arm, LAMS will be removed at 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months after initial drainage procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence of Pancreatic Fluid Collection at 3 and 6 Months
Time Frame: 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.
3 months and 6 months after the initial drainage procedure
Stent-Related Adverse Events
Time Frame: Up to 12 months post-procedure
Incidence of complications directly related to LAMS or DPT placement, including migration, occlusion, infection, or buried stent syndrome.
Up to 12 months post-procedure
Need for Reinterventions
Time Frame: 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.
Within 12 months after stent removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asian Institute of Gastroenterology, India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deepak L Jha, (Medical Gastroenterology), Asian Institute of Gastroenterology, Hyderabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STEP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because data sharing is not planned for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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