Safety and Efficiency of Electrocautery-enhanced Lumen-apposing Stents - a Single Center Experience

NCT05210842 | Unknown

• 1 other identifier: HA Salzburg
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Lumen approximating stents have been used in interventional endoscopy to treat retentions in the upper gastrointestinal tract for 10 years. In the last few years, these have also been used with great success to form new anastomoses, especially in palliative patients. In this regard, many studies have been conducted in recent years. As one of the largest centers for interventional endoscopy in Austria, we have been performing such interventions as standard since 2016. The use of LAMS has become the standard therapy in many places. Most of the literature describes the technical advantages of LAMS, while the complications are less discussed. Although complications are rare with reported rates below 10%, with the multitude of technological and clinical advances in the field, it is important to understand and manage potential complications such as bleeding, perforation and stent migration. Our goal is to evaluate the safety, efficacy, and outcome of all EC-LAMS in a single, high-volume center. Method: Suitable patients are analyzed retrospectively from the existing database. All patients who had a lumen-proximating stent implanted are included.

Conditions

Complication

Keywords

Lumen-apposing metal stents; Complications; Endoscopic ultrasound (EUS)

Outcome Measures

Primary Outcomes (1)

• Complications

  The main outcome measure ist to evaluate how many complications occured during the use of lumen apposing metal stents in a single center

  2016-2021

Study Arms (1)

Lumen apposing metal stent

All patients who had a lumen-proximating stent implanted are included.

Other: Endoscopy

Interventions

Endoscopy OTHER

The procedures are performed using a flexible therapeutic linear array echoendoscope.

Lumen apposing metal stent

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who had a lumen-proximating stent implanted are included.

You may qualify if:

• Age 18 - 99
• Use of an electocautery-assisted lumen apposing stent
• Follow-up of these patients for at least 3 months

You may not qualify if:

• Age younger than 18
• No use of an electrocautery-protected lumen-apposing stent
• Lack of follow-up of at least 3 months

Sponsors & Collaborators

• Salzburger Landeskliniken: lead

Study Sites (1)

Salzburger Landeskliniken

Salzburg, 5020, Austria

RECRUITING

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Franz Singhartinger, Dr.

  Salzburger Landeskliniken

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Gantschnigg, Dr.

CONTACT

06607154088; a.gantschnigg@salk.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

AU (1)