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

Catalan Institute of Health

Status: Completed

Conditions: Pancreatic Collection; Pancreas Necrosis

Treatments: Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENT; Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03100578

PROMETHEUS

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

PLASTIC STENT

Experimental group

Description:

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.

Treatment:

Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENT

SELF EXPANDABLE METALLIC STENT

Active Comparator group

Description:

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.

Treatment:

Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT