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

NCT03282539 | Completed FDA Device

• 1 other identifier: LAMSpig1
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Collection

Keywords

Lumen apposing metal stents; Double pigtail stents; Endoscopic ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

LAMS

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

Device: LAMS

LAMS + pigtail

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

Device: LAMS + pigtail

Interventions

LAMS DEVICE

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

LAMS

LAMS + pigtail DEVICE

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

LAMS + pigtail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Study Officials

• Joan Gornals

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: September 14, 2017
• Study Start: May 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)