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

Completed

• Conditions: Pancreatic Collection
• Interventions: Device: LAMS + pigtail; Device: LAMS

• Registration Number: NCT03282539
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-08
• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Study First Posted: 2017-09-14
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAMS + pigtail	LAMS + pigtail	EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent
LAMS	LAMS	EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain