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

Not Applicable

Completed

• Conditions: Pancreas Necrosis; Pancreatic Collection

• Registration Number: NCT03100578
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Study Start: 2017-06-27
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
RADIOLOGICAL SUCCESS	4 weeks	Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Valldolid, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital San Juan de Dios; 🇪🇸 Pamplona, Navarra, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain