Endoscopic Step-up Approach Vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

September 15, 2024

Study Completion Date

January 1, 2025

Conditions
Pancreatic NecrosisPancreatitis, Acute Necrotizing
Interventions
PROCEDURE

Direct Endoscopic Necrosectomy

Endosonography-guided, transmural drainage of the WONs shall be performed using a lumen-apposing metal stent (LAMS).After placement of the LAMS, EN shall be performed during the same procedure (Direct EN). After DEN, a 7-Fr/4cm double pigtail and a 7-Fr nasocystic irrigation catheter shall be placed through the LAMS. Endoscopic necrosectomy and VARD shall be repeated as often as clinically indicated and logistically possible with a minimum of one day between procedures

PROCEDURE

Step-up Approach

"Endosonography-guided, transmural drainage of the WONs shall be performed using a lumen-apposing metal stent (LAMS). After placement of the LAMS, a 7-Fr/4cm double pigtail stent and a 7-Fr nasocystic catheter shall be placed through the LAMS.~The effect of the index drainage procedure shall be evaluated every 72 hours and next treatment step will depend on whether the patient's condition improves.~If clinical improvement is observed, the drainage regime continues, and no further therapeutic action shall be taken.~In absence of clinical improvement after 72 hours and if supplementary drainage is impossible, the patient shall proceed to endoscopic necrosectomy (EN) or video-assisted retroperitoneal debridement (VARD). Absence of clinical improvement due to causes not related to the WON treatment, e.g., urinary tract or pulmonary infection or iv catheter sepsis, shall not influence the treatment algorithm of the WON."

Trial Locations (1)

Unknown

Copenhagen University Hospital, Hvidovre, Hvidovre

All Listed Sponsors
lead

Copenhagen University Hospital, Hvidovre

OTHER