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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.

Conditions
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Pancreas Necrosis, Pancreatic Collection

Intervention / Treatment
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* Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENT
* Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLASTIC STENT<br>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. | Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENT<br>* 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<br>|
| Active Comparator: SELF EXPANDABLE METALLIC STENT<br>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. | Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RADIOLOGICAL SUCCESS | Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 month | 
| TECHNICAL ASPECTS | Evaluate the technical success, duration of the procedure and level of difficulty. | 1st day | 
| INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY] | Assess safety: complications (immediate, early and late) | 1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month | 
| RECURRENCES | Evaluate recurrences | 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month | 
| COSTS ANALYSIS | Evaluate the costs between the two types of strategy | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PANCREAS, ENDOSCOPIC INTERVENTION, PLASTIC STENT, SELF EXPANDING METALLIC STENT, ENDOSCOPIC TRANSMURAL DRAINAGE, WALLED OFF PANCREATIC NECROSIS