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

Catalan Institute of Health

Status: Completed

Conditions: Pancreatic Collection

Treatments: Device: LAMS + pigtail; Device: LAMS

Study type: Observational

Funder types: Other

Identifiers

NCT03282539

LAMSpig1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

37 participants in 2 patient groups

LAMS

Description:

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

Treatment:

Device: LAMS

LAMS + pigtail

Description:

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

Treatment:

Device: LAMS + pigtail