ComplicationNCT05210842
Safety and Efficiency of Electrocautery-enhanced Lumen-apposing Stents - a Single Center Experience
An observational study of Complication, run by Salzburger Landeskliniken at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Complication
- What is being tested?
- Endoscopy
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2022to Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had a lumen-proximating stent implanted are included.
Who may be able to join
- Age 18 - 99
- Use of an electocautery-assisted lumen apposing stent
- Follow-up of these patients for at least 3 months
Who cannot join
- Age younger than 18
- No use of an electrocautery-protected lumen-apposing stent
- Lack of follow-up of at least 3 months
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Salzburger Landeskliniken
Salzburg, 5020
Antonia Gantschnigg, Dr., 06607154088, a.gantschnigg@salk.at
Franz Singhartinger, Dr.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Complication
- Being tested
- Endoscopy
- Keywords
- Lumen-apposing metal stents, Complications, Endoscopic ultrasound (EUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyOther
The procedures are performed using a flexible therapeutic linear array echoendoscope.
| Study group | Role | What they receive |
|---|---|---|
| Lumen apposing metal stent | All patients who had a lumen-proximating stent implanted are included. Receives: Other: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
The main outcome measure ist to evaluate how many complications occured during the use of lumen apposing metal stents in a single center
Measured: 2016-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Gantschnigg, Salzburger Landeskliniken
- Investigators
- Franz Singhartinger, Dr., Principal investigator, Salzburger Landeskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210842
- Sponsor's protocol ID
- HA Salzburg
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficiency of Electrocautery-enhanced Lumen-apposing Stents - a Single Center Experience
- ClinicalTrials.gov ID
- NCT05210842
- Acronym / sponsor ID
- HA Salzburg
- Conditions
- Complication
- Keywords
- Lumen-apposing metal stents, Complications, Endoscopic ultrasound (EUS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumen apposing metal stent | – | Other: EndoscopyAll patients who had a lumen-proximating stent implanted are included. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had a lumen-proximating stent implanted are included.
Key inclusion criteria (3 listed)
- Age 18 - 99
- Use of an electocautery-assisted lumen apposing stent
- Follow-up of these patients for at least 3 months
Key exclusion criteria (3 listed)
- Age younger than 18
- No use of an electrocautery-protected lumen-apposing stent
- Lack of follow-up of at least 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoscopyThe procedures are performed using a flexible therapeutic linear array echoendoscope. | Other | Lumen apposing metal stent |
Primary outcome
Complications
Time frame: 2016-2021
The main outcome measure ist to evaluate how many complications occured during the use of lumen apposing metal stents in a single center
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franz Singhartinger, Dr. principal investigator
Salzburger Landeskliniken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication, run by Salzburger Landeskliniken at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonia Gantschnigg, Dr. (06607154088, a.gantschnigg@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 2016-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.