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

Study Overview
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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.

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.

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

Conditions
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Pancreatic Collection

Intervention / Treatment
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* Device: LAMS
* Device: LAMS + pigtail


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LAMS<br>EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents. | Device: LAMS<br>* EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents<br>|
| LAMS + pigtail<br>EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent | Device: LAMS + pigtail<br>* EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumen apposing metal stents, Double pigtail stents, Endoscopic ultrasonography