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

Hospital Universitari de Bellvitge99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreas Necrosis Pancreatic Collection

Interventions

WOPN TRANSMURAL DRAINAGE: PLASTIC STENTDEVICE

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 STENTDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (8)

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

Outcomes

Primary Outcomes

RADIOLOGICAL SUCCESS

Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.

Time frame: 4 weeks

Secondary Outcomes

CLINICAL SUCCESS

Evaluate the long-term clinical success (4 months) (metallic vs. plastic) determined by the total resolution or \<3cm of the WOPN, releated with clinical improvement.

Time frame: 4 month

TECHNICAL ASPECTS

Evaluate the technical success, duration of the procedure and level of difficulty.

Time frame: 1st day

INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]

Assess safety: complications (immediate, early and late)

Time frame: 1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month

RECURRENCES

Evaluate recurrences

Time frame: 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month

COSTS ANALYSIS

Evaluate the costs between the two types of strategy

Time frame: 12 month

Data from ClinicalTrials.gov

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