Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

November 27, 2019

Primary Completion Date

April 25, 2022

Study Completion Date

April 25, 2022

Conditions
Pancreatic NecrosisNecrosis 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)."

Trial Locations (1)

32803

Center for Interventional Endoscopy, Orlando

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AdventHealth

OTHER

NCT04113499 - Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention | Biotech Hunter | Biotech Hunter