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

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.

Study Overview

• Status: Recruiting
• Conditions: Complication
• Intervention / Treatment: Other: Endoscopy

Detailed Description

Electrocautery-enhanced lumen-apposing stents (EC-LAMS) were originally designed for drainage of the gallbladder, bile duct, and pancreas pseudocysts.

Numerous studies have shown the effectiveness in treating pseudocysts, abscesses and walled-off pancreatic necrosis by creating a cystogastrostomy or cystoenterostomy tract with a LAMS for drainage and necrosectomy.

In patients suffering from acute cholecystitis, unfit for surgery due to significant comorbidities and/or essential need of anticoagulation, percutaneous gallbladder drainage (PTGBD) was considered as the viable treatment option. However, this procedure comes along with a high incidence of complications like bile leak, bowel perforation, catheter displacement, and cholangitis. Several studies compared the outcome of PTGBD with the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). The results show significantly superior results in the treatment of non-surgical acute cholecystitis patients with EUS-GBD, in order to consider the use of EUS-GBD as the treatment of choice.

Further, newer "off-label indications" of LAMS are to drain the bile duct in case of failed ERCP (endoscopic retrograde cholangiopancreatography) or, in patients where an ERCP is not possible due to malignant distal biliary obstructions, duodenal obstruction, or post-surgery anatomy. The creation of gastro-gastrostomy was used in patients with a gastric bypass to enable to perform an ERCP or drain a postoperative abscess/fluid collection. Results of published studies have already shown satisfactory clinical outcomes in stenting benign structures, mainly strictures near gastrointestinal (GI) anastomoses or due to chronic inflammations (gastroesophageal junction, pylorus).

We aim to evaluate the safety, efficacy, and outcome of all EC-LAMS placed in a single high-volume center.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Antonia Gantschnigg, Dr.; Phone Number: 06607154088; Email: a.gantschnigg@salk.at

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Recruiting
    • Salzburger Landeskliniken
    • Contact: Antonia Gantschnigg, Dr.; Phone Number: 06607154088; Email: a.gantschnigg@salk.at
    • Principal Investigator: Franz Singhartinger, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lumen apposing metal stent; All patients who had a lumen-proximating stent implanted are included.	Other: Endoscopy; The procedures are performed using a flexible therapeutic linear array echoendoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Salzburger Landeskliniken
• Investigators: Principal Investigator: Franz Singhartinger, Dr., Salzburger Landeskliniken

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Complications; Lumen-apposing metal stents; Endoscopic ultrasound (EUS)
• Other Study ID Numbers: HA Salzburg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No