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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2017-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pancreatic Collection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LAMS

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

LAMS

Intervention Type DEVICE

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

LAMS + pigtail

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

LAMS + pigtail

Intervention Type DEVICE

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

Interventions

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LAMS

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

Intervention Type DEVICE

LAMS + pigtail

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No