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

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Collection
• Intervention / Treatment: Device: LAMS; Device: LAMS + pigtail

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients wiht pancreatic fluid collections and indication for EUS-guided transmural drainage in accordance l wiht international creteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LAMS; EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents.	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	Device: LAMS + pigtail; EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Joan Gornals, Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Lumen apposing metal stents; Double pigtail stents; Endoscopic ultrasonography
• Other Study ID Numbers: LAMSpig1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The results of the stuydy will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes