Pancreatitis, Acute NecrotizingSTEP-INNCT07406698
Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis
A study testing EUS-guided transluminal drainage of necrotic collection in people with Pancreatitis, Acute Necrotizing, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
Pancreatic necrosis complicates approximately 20-30% of severe acute pancreatitis cases. While many collections resolve without intervention, persistent symptomatic collections-particularly when infected-are associated with significant morbidity and mortality and frequently require procedural management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute Necrotizing
- What is being tested?
- EUS-guided transluminal drainage of necrotic collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to 31 Dec 2029
- 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 symptomatic necrotic collection diagnosed on MRI or CT abdomen/pelvis, defined as fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall.
- Documented or suspected infected necrotizing pancreatitis 1) Documented infected necrotizing pancreatitis, defined as: i. Positive culture obtained with percutaneous fine needle aspiration from the pancreatic necrotic collection (if intervention is undertaken ≤14 days of onset of acute pancreatitis) ii. OR gas in the necrotic collection on imaging at any time. 2) Suspected infected necrotizing pancreatitis, if >14 days after onset of disease, defined as: i. Persistent organ failure in patients admitted to the ICU ii. OR presence of at least three of the following six clinical/laboratory parameters (SIRS criteria or elevated CRP or elevated procalcitonin) with no other infection focus. These clinical criteria are considered sufficiently reliable only after the initial 14 days of acute pancreatitis:
- Temperature >100.4 °F or <96.8 °F
- Heart rate > 90 beats/min
- Respiratory rate >20 breaths/min or PaCO2 < 32 mmHg
Show all 10Show fewer
- WBC count >12,000/mm³, or <4,000/mm³, or more than 10% immature band cells
- CRP ≥ 30mg/L
- Procalcitonin ≥ 1ng/mL
- Endoscopic drainage of the necrotic collection is technically feasible as deemed by the treating physician.
Who cannot join
- Age < 18 years
- > 26 days after the onset of acute pancreatitis
- Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome).
- Necrotic collection is not amenable for endoscopic intervention.
- Pregnancy.
- Unable to obtain informed consent from the patient or legally authorized representative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orlando Health Digestive Health Institute
Orlando, Florida, 32806
Ji Young Bang, MD MPH, 321-842-2273, jiyoung.bang@orlandohealth.com
About this study
Official title: Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis: The STEP-IN Trial
Pancreatic necrosis complicates approximately 20-30% of severe acute pancreatitis cases. While many collections resolve without intervention, persistent symptomatic collections-particularly when infected-are associated with significant morbidity and mortality and frequently require procedural management. Current guidelines recommend delaying intervention until collections are fully walled off, typically around four weeks. However, in clinical practice, many patients deteriorate before this window is reached.
Prospective data from our institution, supported by recent meta-analyses, suggest that early intervention using modern endoscopic techniques can be performed safely, even when undertaken within the first four weeks of disease onset. We believe that, in appropriately selected patients, early endoscopic intervention may prevent clinical deterioration, reduce complications, shorten hospital stay, and decrease overall healthcare utilization compared with a delayed approach.
To formally evaluate this strategy, an international, multicenter randomized trial is being conducted, entitled Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis (STEP-IN Trial).
Read the detailed description
Acute pancreatitis imposes a significant burden on the US health-care system, resulting in approximately 300,000 hospital admissions annually and generating costs exceeding $2 billion. Necrotizing pancreatitis develops in approximately 20 to 30% of patients with acute pancreatitis. It can mature into a contained necrotic collection, typically four weeks into the disease course. While some collections may resolve without an intervention, persistent collections can result in symptoms such as pain, abdominal fullness restricting nutrition, vomiting due to gastric outlet obstruction, obstructive jaundice due to a large collection in the pancreatic head, new-onset or persisting organ failure, continued unwellness or infection that is associated with a mortality of 15-20%, and requires drainage and necrosectomy.
International guidelines recommend that, when possible, treatment should be delayed in patients with suspected or confirmed infected necrotizing pancreatitis, to allow for the collection to be walled-off with better demarcation and liquefaction of the necrosis, which generally takes around 4 weeks. The main rationale for postponement of an invasive intervention is to prevent complications, but this rationale originated from an era when open surgical necrosectomy was performed.
Recently, there has been a shift away from open surgery towards minimally invasive treatment approaches. The current standard approach for treatment is a minimally invasive step-up approach with percutaneous catheter or transluminal endoscopic drainage as the first step, followed by video-assisted retroperitoneal/sinus-tract or transgastric necrosectomy. The development of cautery-enhanced lumen-apposing metal stents (LAMS) for endoscopic drainage has significantly simplified the technical aspects of the procedure that facilitates its performance even in very sick patients.
Although international guidelines recommend postponing treatment until 4-weeks when the necrosis is better demarcated, in an international survey of expert pancreatologists, 45% of the respondents reported that they recommend immediate catheter drainage as soon as infected pancreatic and peripancreatic necrosis is diagnosed. In addition, a recent clinical practice guideline from the American Gastroenterological Association states that catheter drainage should be strongly considered when there is a concern of infection, even in the early phase of disease. However, a multicenter, randomized trial did not show superiority for immediate over postponed catheter drainage in reducing complications in patients with infected necrotizing pancreatitis.
Prospective data from our institution and from the meta-analysis suggest that interventions can be undertaken safely adopting state-of-the-art endoscopic methods even when the onset of pancreatitis is less than 4 weeks. Our data also suggest that although a significant proportion of patients undergoing early interventions (adopting an endoscopic approach) do not have a fully encapsulated collection, their treatment outcomes are not negatively impacted by such approach. If an early intervention, adopting an endoscopic approach, can be undertaken safely, it potentially can prevent further clinical deterioration and therefore complications, decrease length of hospitalization as patients may not have to wait for 3 to 4 weeks and overall treatment costs as compared to postponing the intervention until 4-weeks when the necrosis is fully walled-off.
The STEP-IN trial therefore is a natural step in the advancement of our understanding of timing of interventions in necrotizing pancreatitis as it answers an important clinical question: can early interventions be undertaken safely without subjecting patients to an arbitrary time frame of 4-weeks? In this study we challenge the existing paradigm of delayed intervention in attempt to further improve the clinical outcomes in patients with infected necrotizing pancreatitis.
- Conditions
- Pancreatitis, Acute Necrotizing
- Being tested
- EUS-guided transluminal drainage of necrotic collection
- Keywords
- Endoscopic ultrasound, Drainage, Necrotic collection, Timing of intervention
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided transluminal drainage of necrotic collectionProcedure or surgery
EUS-guided drainage of the necrotic collection is performed by placement of a metal stent within the dominant collection.
| Study group | Role | What they receive |
|---|---|---|
| Early endoscopic intervention in infected necrotizing pancreatitis | Active comparator | In the early treatment group, EUS-guided drainage is undertaken within 72 hours of randomization, earlier than 28 days after the onset of acute pancreatitis. Receives: Procedure: EUS-guided transluminal drainage of necrotic collection |
| Postponed endoscopic intervention in infected necrotizing pancreatitis | Active comparator | In the postponed treatment group, EUS-guided drainage is undertaken only from 28 days after the onset of acute pancreatitis when the collection is fully or predominantly walled-off (encapsulated). Receives: Procedure: EUS-guided transluminal drainage of necrotic collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major complications or death
Proportion of patients experiencing a major complication or death. Major complications comprise new onset organ failure, new onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, intraabdominal bleeding, or visceral perforation.
Measured: 6 months
Secondary outcomes (23)
Mortality
Proportion of patients with mortality from any cause
Measured: 6 months
Major complications
Proportion of patients experiencing major complications. Major complications comprise new onset organ failure (respiratory, cardiovascular, renal, gastrointestinal, hepatic, hematologic, neurologic, or metabolic failure), new onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, intraabdominal bleeding, or visceral perforation
Measured: 6 months
New onset single and multiple organ failure
Proportion of patients with new onset failure of at least one organ system
Measured: 6 months
New onset systemic dysfunction
Proportion of patients with worsening of any pre-existing medical condition
Measured: 6 months
Enterocutaneous and pancreatic fistula
Proportion of patients with enterocutaneous fistula or pancreatic fistula. Enterocutaneous fistula is the formation of a fistula between the small bowel or colon and skin as indicated by feculent output from a percutaneous catheter or surgical wound site, confirmed on imaging or surgery.
Pancreatic fistula is the formation of a fistula between the pancreas and skin as indicated by amylase-rich fluid output from a percutaneous catheter or surgical wound site, persisting after 3 months, and requiring specific treatment that include parenteral or enteral nutrition, antibiotics, somatostatin analogues and minimally invasive drainage.
Measured: 6 months
Intraabdominal bleeding
Proportion of patients with intraabdominal bleeding. Intraabdominal bleeding is defined as bleeding within the intraabdominal cavity or gastrointestinal tract requiring interventional procedure
Measured: 6 monthts
Visceral perforation
Proportion of patients with visceral perforation. Visceral perforation is defined as the perforation of a visceral organ requiring interventional procedure
Measured: 6 months
Incisional hernia
Proportion of patients with incisional hernia. Incisional hernia is defined as herniation of intraabdominal structures through an area of weakness in the abdominal fascia, requiring surgical intervention or persisting at 6-month follow-up
Measured: 6 months
Surgical site infection
Proportion of patients with surgical site infection. Surgical site infection is defined as the infection in superficial or deep layers of the abdominal wall at the site of prior intervention, as evident by the presence of purulent drainage or abscess on physical examination, imaging and/or requiring intervention
Measured: 6 months
New onset diabetes
Proportion of patients with new onset diabetes. New onset diabetes is defined as new onset elevation in fasting plasma glucose ≥ 126 mg/dL, 2-hour plasma glucose ≥ 200 mg/dL after an oral glucose tolerance test or HbA1c ≥ 6.5%
Measured: 6 months
New diagnosis of exocrine pancreatic insufficiency
Proportion of patients with new diagnosis of exocrine pancreatic insufficiency. Exocrine pancreatic insufficiency is defined as fecal elastase level < 200μg/g in patients not previously taking pancreatic enzyme supplements
Measured: 6 months
Procedure-related adverse events
Proportion of patients with any adverse event resulting from endoscopic or surgical intervention
Measured: 6 months
Disease-related adverse events
Proportion of patients with any adverse event resulting from necrotizing pancreatitis
Measured: 6 months
Number of interventions
Number of interventions performed for treatment of infected necrotizing pancreatitis including endoscopic, surgical and radiological interventions
Measured: 6 months
Length of hospitalization
Length of hospitalization, including length of ICU stay
Measured: 6 months
Readmissions
Proportion of patients with hospital admissions due to underlying disease or procedure-related adverse events
Measured: 6 months
Presence of systemic inflammatory response syndrome (SIRS) at 72 hours post-index intervention
Proportion of patients with positive SIRS at 72 hours post-index procedure. Positive SIRS is defined by the presence of at least two of the following four criteria:
- Body temperature >100.4 °F or < 96.8 °F
- Heart rate > 90 beats/minute
- Respiratory rate > 20 breaths/minute or PaCO2 < 32mmHg
- White blood cell count > 12 or < 4 x109/L or > 10% immature neutrophils
Measured: 72 hours
New onset systemic inflammatory response syndrome (SIRS) at 72 hours post-index intervention
Proportion of patients with new onset SIRS at 72 hours post-index intervention. Positive SIRS is defined by the presence of at least two of the following four criteria:
- Body temperature >100.4 °F or < 96.8 °F
- Heart rate > 90 beats/minute
- Respiratory rate > 20 breaths/minute or PaCO2 < 32mmHg
- White blood cell count > 12 or < 4 x109/L or > 10% immature neutrophils
Measured: 72 hours
Resolution and improvement of systemic inflammatory response syndrome (SIRS) at 72 hours post-index intervention
Proportion of patients with resolution of SIRS at 72 hours post-index intervention. Positive SIRS is defined by the presence of at least two of the following four criteria:
- Body temperature >100.4 °F or < 96.8 °F
- Heart rate > 90 beats/minute
- Respiratory rate > 20 breaths/minute or PaCO2 < 32mmHg
- White blood cell count > 12 or < 4 x109/L or > 10% immature neutrophils
Measured: 72 hours
Technical success
Rate of technical success. Technical success is defined as the successful completion of EUS-guided drainage of the necrotic collection
Measured: 6 months
Treatment success
Rate of treatment success. Treatment success is defined as the resolution of necrotic collection on CT scan in association with clinical resolution of symptoms at 6 months from index intervention
Measured: 6 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) scores as assessed by the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36)
Measured: 6 months
Overall treatment costs
Overall treatment costs from admission until hospital discharge. All relevant costs pertaining to treatment will be taken into consideration - procedure costs, cost of inpatient hospital stay (from date of procedure to discharge), cost of medications, cost of materials, cost of anesthesia, cost of pharmacy and cost of imaging studies.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start28 Jan 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, Acute NecrotizingStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Young Bang, MD MPH, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406698
- Sponsor's protocol ID
- 2401309
- Acronym
- STEP-IN
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis: The STEP-IN Trial
- ClinicalTrials.gov ID
- NCT07406698
- Acronym / sponsor ID
- STEP-IN / 2401309
- Conditions
- Pancreatitis, Acute Necrotizing
- Keywords
- Endoscopic ultrasound, Drainage, Necrotic collection, Timing of intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Feb 2026 (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.
Pancreatic necrosis complicates approximately 20-30% of severe acute pancreatitis cases. While many collections resolve without intervention, persistent symptomatic collections-particularly when infected-are associated with significant morbidity and mortality and frequently require procedural management. Current guidelines recommend delaying intervention until collections are fully walled off, typically around four weeks. However, in clinical practice, many patients deteriorate before this window is reached.
Prospective data from our institution, supported by recent meta-analyses, suggest that early intervention using modern endoscopic techniques can be performed safely, even when undertaken within the first four weeks of disease onset. We believe that, in appropriately selected patients, early endoscopic intervention may prevent clinical deterioration, reduce complications, shorten hospital stay, and decrease overall healthcare utilization compared with a delayed approach.
To formally evaluate this strategy, an international, multicenter randomized trial is being conducted, entitled Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis (STEP-IN Trial).
Detailed description
Acute pancreatitis imposes a significant burden on the US health-care system, resulting in approximately 300,000 hospital admissions annually and generating costs exceeding $2 billion. Necrotizing pancreatitis develops in approximately 20 to 30% of patients with acute pancreatitis. It can mature into a contained necrotic collection, typically four weeks into the disease course. While some collections may resolve without an intervention, persistent collections can result in symptoms such as pain, abdominal fullness restricting nutrition, vomiting due to gastric outlet obstruction, obstructive jaundice due to a large collection in the pancreatic head, new-onset or persisting organ failure, continued unwellness or infection that is associated with a mortality of 15-20%, and requires drainage and necrosectomy.
International guidelines recommend that, when possible, treatment should be delayed in patients with suspected or confirmed infected necrotizing pancreatitis, to allow for the collection to be walled-off with better demarcation and liquefaction of the necrosis, which generally takes around 4 weeks. The main rationale for postponement of an invasive intervention is to prevent complications, but this rationale originated from an era when open surgical necrosectomy was performed.
Recently, there has been a shift away from open surgery towards minimally invasive treatment approaches. The current standard approach for treatment is a minimally invasive step-up approach with percutaneous catheter or transluminal endoscopic drainage as the first step, followed by video-assisted retroperitoneal/sinus-tract or transgastric necrosectomy. The development of cautery-enhanced lumen-apposing metal stents (LAMS) for endoscopic drainage has significantly simplified the technical aspects of the procedure that facilitates its performance even in very sick patients.
Although international guidelines recommend postponing treatment until 4-weeks when the necrosis is better demarcated, in an international survey of expert pancreatologists, 45% of the respondents reported that they recommend immediate catheter drainage as soon as infected pancreatic and peripancreatic necrosis is diagnosed. In addition, a recent clinical practice guideline from the American Gastroenterological Association states that catheter drainage should be strongly considered when there is a concern of infection, even in the early phase of disease. However, a multicenter, randomized trial did not show superiority for immediate over postponed catheter drainage in reducing complications in patients with infected necrotizing pancreatitis.
Prospective data from our institution and from the meta-analysis suggest that interventions can be undertaken safely adopting state-of-the-art endoscopic methods even when the onset of pancreatitis is less than 4 weeks. Our data also suggest that although a significant proportion of patients undergoing early interventions (adopting an endoscopic approach) do not have a fully encapsulated collection, their treatment outcomes are not negatively impacted by such approach. If an early intervention, adopting an endoscopic approach, can be undertaken safely, it potentially can prevent further clinical deterioration and therefore complications, decrease length of hospitalization as patients may not have to wait for 3 to 4 weeks and overall treatment costs as compared to postponing the intervention until 4-weeks when the necrosis is fully walled-off.
The STEP-IN trial therefore is a natural step in the advancement of our understanding of timing of interventions in necrotizing pancreatitis as it answers an important clinical question: can early interventions be undertaken safely without subjecting patients to an arbitrary time frame of 4-weeks? In this study we challenge the existing paradigm of delayed intervention in attempt to further improve the clinical outcomes in patients with infected necrotizing pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early endoscopic intervention in infected necrotizing pancreatitis | Active comparator | Procedure: EUS-guided transluminal drainage of necrotic collectionIn the early treatment group, EUS-guided drainage is undertaken within 72 hours of randomization, earlier than 28 days after the onset of acute pancreatitis. |
| Postponed endoscopic intervention in infected necrotizing pancreatitis | Active comparator | Procedure: EUS-guided transluminal drainage of necrotic collectionIn the postponed treatment group, EUS-guided drainage is undertaken only from 28 days after the onset of acute pancreatitis when the collection is fully or predominantly walled-off (encapsulated). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Patients with symptomatic necrotic collection diagnosed on MRI or CT abdomen/pelvis, defined as fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall.
- Documented or suspected infected necrotizing pancreatitis 1) Documented infected necrotizing pancreatitis, defined as: i. Positive culture obtained with percutaneous fine needle aspiration from the pancreatic necrotic collection (if intervention is undertaken ≤14 days of onset of acute pancreatitis) ii. OR gas in the necrotic collection on imaging at any time. 2) Suspected infected necrotizing pancreatitis, if >14 days after onset of disease, defined as: i. Persistent organ failure in patients admitted to the ICU ii. OR presence of at least three of the following six clinical/laboratory parameters (SIRS criteria or elevated CRP or elevated procalcitonin) with no other infection focus. These clinical criteria are considered sufficiently reliable only after the initial 14 days of acute pancreatitis:
- Endoscopic drainage of the necrotic collection is technically feasible as deemed by the treating physician.
Key exclusion criteria (6 listed)
- Age < 18 years
- > 26 days after the onset of acute pancreatitis
- Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome).
- Necrotic collection is not amenable for endoscopic intervention.
- Pregnancy.
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 |
|---|---|---|
| EUS-guided transluminal drainage of necrotic collectionEUS-guided drainage of the necrotic collection is performed by placement of a metal stent within the dominant collection. | Procedure or surgery | Early endoscopic intervention in infected necrotizing pancreatitis, Postponed endoscopic intervention in infected necrotizing pancreatitis |
Primary outcome
Composite of major complications or death
Time frame: 6 months
Proportion of patients experiencing a major complication or death. Major complications comprise new onset organ failure, new onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, intraabdominal bleeding, or visceral perforation.
23 secondary outcomes
Mortality
Time frame: 6 months
Major complications
Time frame: 6 months
New onset single and multiple organ failure
Time frame: 6 months
New onset systemic dysfunction
Time frame: 6 months
Enterocutaneous and pancreatic fistula
Time frame: 6 months
Intraabdominal bleeding
Time frame: 6 monthts
Visceral perforation
Time frame: 6 months
Incisional hernia
Time frame: 6 months
Surgical site infection
Time frame: 6 months
New onset diabetes
Time frame: 6 months
New diagnosis of exocrine pancreatic insufficiency
Time frame: 6 months
Procedure-related adverse events
Time frame: 6 months
Disease-related adverse events
Time frame: 6 months
Number of interventions
Time frame: 6 months
Length of hospitalization
Time frame: 6 months
Readmissions
Time frame: 6 months
Presence of systemic inflammatory response syndrome (SIRS) at 72 hours post-index intervention
Time frame: 72 hours
New onset systemic inflammatory response syndrome (SIRS) at 72 hours post-index intervention
Time frame: 72 hours
Resolution and improvement of systemic inflammatory response syndrome (SIRS) at 72 hours post-index intervention
Time frame: 72 hours
Technical success
Time frame: 6 months
Treatment success
Time frame: 6 months
Health-related quality of life (HRQoL)
Time frame: 6 months
Overall treatment costs
Time frame: 6 months
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 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ji Young Bang, MD MPH principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided transluminal drainage of necrotic collection in people with Pancreatitis, Acute Necrotizing, run by Orlando Health, Inc. at 1 site in United States.
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 10 inclusion and 6 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 12 Feb 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 United States. 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 Ji Young Bang, MD MPH (321-842-2273, jiyoung.bang@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major complications or death (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.