Orlando, FLNCT07406698Now EnrollingIRB Ready

Pancreatitis, Acute Necrotizing Clinical Trial in Orlando, FL

Access cutting-edge pancreatitis, acute necrotizing treatment through this clinical trial at a research site in Orlando. Study-provided care at no cost to qualified participants.

Sponsored by Orlando Health, Inc.

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Expert Care in Orlando

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pancreatitis, acute necrotizing treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Orlando

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Orlando site if eligible
  4. 4Begin participation

About This Pancreatitis, Acute Necrotizing Study in Orlando

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).

Sponsor: Orlando Health, Inc.

Who Can Participate

Inclusion Criteria

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
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.

Exclusion Criteria

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.
Unable to obtain informed consent from the patient or legally authorized representative.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT07406698) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pancreatitis, Acute Necrotizing Treatment Options in Orlando, FL

If you're searching for pancreatitis, acute necrotizing treatment options in Orlando, FL, this clinical trial (NCT07406698) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pancreatitis, acute necrotizing specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pancreatitis, acute necrotizing clinical trials near you to find additional studies recruiting in your area.

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