Clinical trial NCT05210842: Safety and Efficiency of Electrocautery-enhanced Lumen-apposing Stents - a Single Center Experience
Official title: Safety and Efficiency of Electrocautery-enhanced Lumen-apposing Stents - a Single Center Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication
Keywords: Lumen-apposing metal stents
Complications
Endoscopic ultrasound (EUS)
Lead sponsor: Salzburger Landeskliniken
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had a lumen-proximating stent implanted are included.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complications
timeFrame: 2016-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
Study officials:
affiliation: Salzburger Landeskliniken
name: Franz Singhartinger, Dr.
role: PRINCIPAL_INVESTIGATOR
References: