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

Hospital Universitari de Bellvitge8 sites in 1 country99 target enrollmentJune 27, 2017

ConditionsPancreas Necrosis Pancreatic Collection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pancreas Necrosis
Sponsor: Hospital Universitari de Bellvitge
Enrollment: 99
Locations: 8
Primary Endpoint: RADIOLOGICAL SUCCESS
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 27, 2017

End Date

October 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Universitari de Bellvitge

Responsible Party

Principal Investigator

Joan B Gornals

Principal Investigator

Hospital Universitari de Bellvitge

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)

Outcomes

Primary Outcomes

RADIOLOGICAL SUCCESS

Time Frame: 4 weeks

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

Secondary Outcomes

CLINICAL SUCCESS(4 month)
TECHNICAL ASPECTS(1st day)
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)
RECURRENCES(4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month)
COSTS ANALYSIS(12 month)