Step-up endoscopic intervention for Acute Necrotizing Pancreatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Necrotizing PancreatitisImmediate endoscopic necrosectomy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two different ways to do surgery on the pancreas for people with a certain kind of pancreatitis.

Eligible Conditions
  • Acute Necrotizing Pancreatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: 6 months

24 hours
Rate of technical success for EUS-guided cystogastrostomy
Rate of technical success for endoscopic necrosectomy
6 months
Overall treatment costs from admission until 6 months post index intervention, measured in US dollars
Post-procedure length of intensive care unit (ICU) stay
Rate of disease-related adverse events
Rate of exocrine pancreatic insufficiency
Rate of new onset diabetes
Rate of procedure-related adverse events
Rate of treatment success
Total length of hospital stay
Total number of procedures required for treatment success
Total number of readmissions due to disease-related symptoms or procedure-related events
72 hours
Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention
Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Step-up endoscopic intervention
1 of 2
Immediate endoscopic necrosectomy
1 of 2

Active Control

70 Total Participants · 2 Treatment Groups

Primary Treatment: Step-up endoscopic intervention · No Placebo Group · N/A

Step-up endoscopic intervention
Procedure
ActiveComparator Group · 1 Intervention: Step-up endoscopic interventions · Intervention Types: Procedure
Immediate endoscopic necrosectomy
Procedure
ActiveComparator Group · 1 Intervention: Immediate endoscopic necrosectomy · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

University of Alabama at BirminghamOTHER
1,435 Previous Clinical Trials
2,229,164 Total Patients Enrolled
Asian Institute of Gastroenterology, IndiaOTHER
63 Previous Clinical Trials
12,596 Total Patients Enrolled
Marshall UniversityOTHER
17 Previous Clinical Trials
2,443 Total Patients Enrolled
Orlando Health, Inc.Lead Sponsor
22 Previous Clinical Trials
11,336 Total Patients Enrolled
University of Southern CaliforniaOTHER
827 Previous Clinical Trials
1,419,934 Total Patients Enrolled
West Virginia UniversityOTHER
161 Previous Clinical Trials
50,367 Total Patients Enrolled
Rush UniversityOTHER
36 Previous Clinical Trials
27,617 Total Patients Enrolled
Mayo ClinicOTHER
2,922 Previous Clinical Trials
3,517,083 Total Patients Enrolled
Ji Young Bang, MD MPHPrincipal InvestigatorOrlando Health
3 Previous Clinical Trials
657 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Necrotic collection visualized on EUS and amenable to EUS-guided drainage.