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

Lumen Apposing Metal Stents With and Without a Coaxial Double Pigtail Stent in the Management of Pancreatic Fluid Collections

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03282539

Enrollment

Registered

2017-09-14

Start date

2011-05-31

Completion date

2017-02-28

Last updated

2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Collection

Keywords

Lumen apposing metal stents, Double pigtail stents, Endoscopic ultrasonography

Brief summary

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

Detailed 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.

Interventions

DEVICELAMS

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

DEVICELAMS + pigtail

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Adverse events	Outcomes will be assessed 6 months after the inclusion of last patient.	Defined and graded according to the ASGE lexicon's severity grading system

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026