EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.
NCT ID: NCT03100578
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2017-06-27
2021-10-30
Brief Summary
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Spanish centers partners of the spanish society of digestive endoscopy.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PLASTIC STENT
Endoscopic double pigtail plastic stent, with formal indication on pancreatic collection, according to the instruction forms of the manufacturer.
Interventions associated:
EUS-guided transmural drainage of pancretic collection: PLASTIC STENT.
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
SELF EXPANDABLE METALLIC STENT
Lumen apposing metal stent with formal indicaction on pancreatic collection, according to the manufacturer instruction forms.
Interventions associated:
EUS-guided transmural drainage of pancretic collection: METALLIC STENT.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Patient with indication (ASGE, Jacobson BC, GIE2005;) of pancreatic collection drainage type WALLED-OFF PANCREATIC NECROSIS \* as a local complication of previous acute pancreatitis.
* Patient trained to understand and / or sign informed consent
* Patient who understands the type of study and will comply with all follow-up of complementary tests during its duration
Exclusion Criteria
* Severe coagulation disorder: INR\> 1.5 not correctable with plasma and / or platelet administration \<50,000 / mm3
* Asymptomatic patients, with no clinical indication of drainage, except for those with vascular involvement due to compression (eg stenosis, splenic vessels with collateral circulation, and risk of bleeding)
* Non-identification of solid content during the Endoscopic Ultrasound of the procedure
* No informed consent
* In the case of patients with mental retardation, without the ability to understand the nature and possible consequences of the study, except for the existence of a legal representative
* Patients unable to maintain posterior follow-up (lack of adherence)
* Situations that do not allow the practice of a high digestive endoscopy (eg, stenosis)
18 Years
ALL
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Spanish Clinical Research Network - SCReN
NETWORK
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Joan B Gornals
Principal Investigator
Principal Investigators
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JOAN B GORNALS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge - IDIBELL
Locations
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Hospital Arnau de Vilanova
Lleida, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital San Juan de Dios
Pamplona, Navarre, Spain
Hospital Universitario Río Hortega
Valladolid, Valldolid, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Countries
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References
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Gornals JB, Velasquez-Rodriguez JG, Bas-Cutrina F, Garcia Garcia De Paredes A, Esteban JM, Teran A, Gonzalez-Huix F, Perez-Miranda M, Guarner-Argente C, Vila JJ, Garcia-Sumalla A, Foruny JR, Fisac-Vazquez J, Moris M, Miquel-Salas I, De-la-Serna Higuera C, Murzi-Pulgar M, Sanchez-Yague A, Salord S, Ruiz-Osuna S, Busquets J, Sanllorente-Melenchon M, Videla S, Moreno R, Tebe-Cordomi C, Hereu P, Vazquez-Sequeiros E; Spanish Working Group on Pancreatic Collection Therapy. Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial. Surg Endosc. 2024 Apr;38(4):2148-2159. doi: 10.1007/s00464-024-10699-w. Epub 2024 Mar 6.
Gornals JB, Perez-Miranda M, Vazquez-Sequeiros E, Vila J, Esteban JM, Gonzalez-Huix F, Guarner-Argente C, Sanchez-Yague A, Teran A, Bas-Cutrina F, De La Serna C, De Paredes AG, Ballester R, Velasquez-Rodriguez J, Salord S, Tebe C, Hereu P, Videla S; Spanish Working Group on Pancreatic Collection Therapy. Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol. Trials. 2019 Dec 30;20(1):791. doi: 10.1186/s13063-019-3988-x.
Other Identifiers
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PROMETHEUS
Identifier Type: -
Identifier Source: org_study_id