Lumen Apposing Metal Stents With and Without a Double Pigtail Stent in Pancreatic Collections

Hospital Universitari de Bellvitge37 enrolled

Overview

The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic stent in the management of pancreatic fuid collections.

The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer than other types of stents due to the presence of bilateral anchoring flanges, designed to appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC, specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS syndrome have also been related . The placement of a coaxial double pigtail plastic within the LAMS has been reported beneficial in order to avoid external migration or the lumen obstruction and to the prevention of bleeding and other adverse events. The aim of this study was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail plastic stent in the EUS-guided transmural drainage of PFCs.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Collection

Interventions

LAMSDEVICE

EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents

LAMS + pigtailDEVICE

EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with pancreatic fluid collections and indication of drainage. * EUS-guided trasmural drainage wiht lumen apposing metal stents. * Criteria for drainage were as specified by the Working Group of the International Association of Pancreatology. Exclusion Criteria: * Other types of collections and stents * Severe coagulopathy (protombin time \> 1,5) or thrombocytopenia (platelet count \< 50 x 109/L) * PFCs with a previous attempt failed of EUS-guided transmural drainage * Age younger than 18 years

Locations (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Outcomes

Primary Outcomes

Adverse events

Defined and graded according to the ASGE lexicon's severity grading system

Time frame: Outcomes will be assessed 6 months after the inclusion of last patient.

Data from ClinicalTrials.gov

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