What is the mechanism of action of this treatment?

The most common treatments for Acute Necrotizing Pancreatitis, such as Immediate Endoscopic Necrosectomy and Step-Up Endoscopic Interventions, focus on the removal of necrotic tissue. Immediate Endoscopic Necrosectomy involves the direct removal of necrotic tissue through an endoscope, which can quickly reduce infection and inflammation. The Step-Up approach begins with less invasive drainage procedures and progresses to necrosectomy if needed, aiming to minimize complications. These treatments are crucial for controlling infection, reducing inflammation, and preventing further complications, thereby improving patient outcomes in Acute Necrotizing Pancreatitis.

What side effects are associated with this type of intervention?

The most common treatments for Acute Necrotizing Pancreatitis, such as immediate endoscopic necrosectomy and step-up endoscopic interventions, can have several side effects. These include infection, bleeding, perforation of the gastrointestinal tract, and exacerbation of pancreatitis. Additionally, patients may experience complications such as organ failure, particularly respiratory and renal failure, and prolonged hospital stays due to the severity of the condition and the invasiveness of the procedures.

What prior FDA approvals exist?

There is limited specific information on FDA-approved drugs exclusively for the treatment of Acute Necrotizing Pancreatitis. The primary treatment approach for this condition often involves endoscopic or surgical interventions rather than pharmacological treatments. The trial comparing Immediate Endoscopic Necrosectomy vs. Step-Up Endoscopic Interventions focuses on procedural management rather than drug therapy. Generally, management includes supportive care, antibiotics for infection, and interventions to remove necrotic tissue, but specific FDA-approved drugs for this condition are not highlighted.

What other types of research exist?

Promising novel alternatives for treating acute necrotizing pancreatitis in 2024 include: 1) Minimally invasive surgical techniques such as video-assisted retroperitoneal debridement (VARD), which offers a less invasive approach compared to traditional surgery. 2) Endoscopic transluminal necrosectomy (ETN), which allows for direct removal of necrotic tissue through the gastrointestinal tract, reducing the need for external incisions. 3) Advanced pharmacological therapies targeting inflammation and infection control, potentially reducing the need for surgical intervention. 4) Enhanced supportive care protocols, including optimized fluid management, nutritional support, and early use of antibiotics, which can improve patient outcomes and reduce complications.

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Procedure

Endoscopic Surgery Techniques for Pancreatitis (DESTIN Trial)

N/A

Waitlist Available

Led By Ji Young Bang, MD MPH

Research Sponsored by Orlando Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods of using a camera and tools through the mouth to remove dead tissue from the pancreas in patients with necrotizing pancreatitis. One method does it all at once, while the other does it gradually. The goal is to see which method works better for these patients.

Who is the study for?

This trial is for adults over 18 with necrotizing pancreatitis, who have a symptomatic necrotic collection visible on MRI or CT scans and suitable for drainage guided by endoscopic ultrasound (EUS). It's not for those under 18, pregnant women, patients with severe clotting issues, those on certain anticoagulants that can't be stopped, or if consent cannot be obtained.

What is being tested?

The study compares two approaches to treating necrotizing pancreatitis: immediate removal of dead tissue through an endoscope versus a gradual treatment approach starting with less invasive procedures. Patients are randomly assigned to one of these treatments.

What are the potential side effects?

Potential side effects may include bleeding, infection at the site of intervention, pain related to the procedure(s), possible damage to surrounding organs during the procedure and reactions related to sedation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total number of reinterventions required for treatment success

Secondary study objectives

Overall treatment costs measured in US dollars

Post-procedure length of intensive care unit (ICU) stay

Rate of disease-related adverse events

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Immediate endoscopic necrosectomyActive Control1 Intervention

Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Then in this group, endoscopic necrosectomy will be performed immediately following index EUS-guided drainage of the necrotic collection, during the same session

Group II: Step-up endoscopic interventionActive Control1 Intervention

Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. In this group, only EUS-guided drainage of the necrotic collection will be performed, and endoscopic necrosectomy will be performed at a separate session at a later time as needed.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Necrotizing Pancreatitis, such as Immediate Endoscopic Necrosectomy and Step-Up Endoscopic Interventions, focus on the removal of necrotic tissue. Immediate Endoscopic Necrosectomy involves the direct removal of necrotic tissue through an endoscope, which can quickly reduce infection and inflammation. The Step-Up approach begins with less invasive drainage procedures and progresses to necrosectomy if needed, aiming to minimize complications. These treatments are crucial for controlling infection, reducing inflammation, and preventing further complications, thereby improving patient outcomes in Acute Necrotizing Pancreatitis.