Clinical trial NCT03100578: EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.
Official title: Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Necrosis
Pancreatic Collection
Keywords: PANCREAS
ENDOSCOPIC INTERVENTION
PLASTIC STENT
SELF EXPANDING METALLIC STENT
ENDOSCOPIC TRANSMURAL DRAINAGE
WALLED OFF PANCREATIC NECROSIS
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: Spanish Clinical Research Network - SCReN
First posted: 2017-04-04
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis.

Spanish centers partners of the spanish society of digestive endoscopy.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* 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:

* Pregnancy or breastfeeding
* 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)

Primary outcomes:
measure: RADIOLOGICAL SUCCESS
timeFrame: 4 weeks
Secondary outcomes:
measure: CLINICAL SUCCESS
timeFrame: 4 month
measure: TECHNICAL ASPECTS
timeFrame: 1st day
measure: INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]
timeFrame: 1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
measure: RECURRENCES
timeFrame: 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
measure: COSTS ANALYSIS
timeFrame: 12 month
Other outcomes:
measure: TECHNICAL ASPECTS
timeFrame: 1st day
measure: TECHNICAL ASPECTS
timeFrame: 1st day
measure: TECHNICAL ASPECTS
timeFrame: 1st day
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Hospital San Juan de Dios
state: Navarra
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
state: Valldolid
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Hospital Universitari de Bellvitge - IDIBELL
name: JOAN B GORNALS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.