MedTrace Logo

Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention

NCT04113499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-07-12

No results posted yet for this study

Summary

This trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.

Conditions

  • Pancreatic Necrosis
  • Necrosis Pancreas

Interventions

PROCEDURE

Direct Endoscopic Intervention

The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities. For endoscopic necrosectomy, in patients allocated to direct endoscopic necrosectomy group, endoscopic necrosectomy is performed during the same session as the index endoscopic drainage. It is performed using a therapeutic gastroscope and various accessories (see below for further details) for 90 to 120 minutes.

PROCEDURE

Step-up Endoscopic Intervention

The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities. In patients allocated to the step-up endoscopic interventions group, endoscopic necrosectomy is not performed at the time of the index intervention, however it is performed when clinically indicated during the follow-up period (6 months from index intervention).

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Muhammad Hasan, MD · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-27
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113499 on ClinicalTrials.gov