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

Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210842
• Other study ID #: HA Salzburg
• Status: Recruiting
• Start date: February 2022
• Est. completion date: February 2022

Study information

• Verified date: January 2022
• Source: Salzburger Landeskliniken
• Contact: Antonia Gantschnigg, Dr.
• Phone: 06607154088
• Email: a.gantschnigg[@]salk.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication

Intervention

Other:
• Endoscopy
The procedures are performed using a flexible therapeutic linear array echoendoscope.

Locations

Country	Name	City	State
Austria	Salzburger Landeskliniken	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Salzburger Landeskliniken

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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