EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.

NACompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

June 27, 2017

Primary Completion Date

October 30, 2021

Study Completion Date

October 30, 2021

Conditions
Pancreas NecrosisPancreatic Collection
Interventions
DEVICE

WOPN TRANSMURAL DRAINAGE: PLASTIC STENT

"Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis:~The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels.~This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist.~Placement of a plastic double pigtail, 5-10 cm in length, diameters 7-8,5-10 Fr. Minimum one 10 Fr prosthesis.~Arm associated: PLASTIC STENT"

DEVICE

WOPN TRANSMURAL DRAINAGE: METALLIC STENT

"Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis:~The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels.~This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist.~Placement of a metal self-expanding fully covered luminal apposition stent: 10, 15 or 20 mm diameter.~Arm associated: SELF EXPANDABLE METALLIC STENT"

Trial Locations (8)

25198

Hospital Arnau de Vilanova, Lleida

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clínico San Carlos, Madrid

29603

Hospital Costa del Sol, Marbella

31006

Hospital San Juan de Dios, Pamplona

39008

Hospital Universitario Marqués de Valdecilla, Santander

47012

Hospital Universitario Río Hortega, Valladolid

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

All Listed Sponsors
collaborator

Carlos III Health Institute

OTHER_GOV

collaborator

Spanish Clinical Research Network - SCReN

NETWORK

lead

Hospital Universitari de Bellvitge

OTHER

NCT03100578 - EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis. | Biotech Hunter | Biotech Hunter