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

Pancreatic Collection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282539
• Other study ID #: LAMSpig1
• Status: Completed
• Phase: N/A
• First received: August 8, 2017
• Last updated: September 12, 2017
• Start date: May 2011
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Collection

Intervention

Device:
• LAMS
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

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.