Acute CholecystitisAC LAMSNCT05272007
Endoscopic Ultrasonography (EUS) Guided Gallbladder Drainage With Two Months Stent Removal for Acute Cholecystitis: a Prospective Study
An observational study of Acute Cholecystitis, run by Istituto Clinico Humanitas Mater Domini at 1 site in Italy.
Trial summary
Acute cholecystitis (AC) is defined as an acute inflammatory disease of the gallbladder consequently to the presence of sludge or stones. AC accounts for 3-10% of all cases of abdominal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- EUS-biliary drainage
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2022to 31 Dec 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This is an observational multicentric prospective study. Data from consecutive patients with AC will be evaluated and, if eligible and agreed to participate, will be recorded in an electronic register. Patients will be followed until death or for at least 1 year after stent removal.
Who may be able to join
- Age ≥18 years
- Patients arrived to the ER for AC with clinical and radiological evidence of AC (such as abdominal ultrasound, computed tomography or magnetic resonance)
- EUS gallbladder accessibility from the duodenum or from the stomach for the drainage
- Agree to receive follow up phone calls
- Able to provide written informed consent
Who cannot join
- Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000
- Use of anticoagulants that cannot be discontinued
- Pregnant women
- Inability to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas-Mater Domini
Castellanza, 21053
Benedetto Mangiavillano, MD, (+39) 0331 476205 - 381, benedetto.mangiavillano@mc.humanitas.it
About this study
Acute cholecystitis (AC) is defined as an acute inflammatory disease of the gallbladder consequently to the presence of sludge or stones. AC accounts for 3-10% of all cases of abdominal pain. Cholecystolithiasis accounts for 90-95% of all causes of acute cholecystitis, while acalculous cholecystitis accounts for the remaining 5-10% of the cases. Laparoscopic cholecystectomy is actually the gold standard treatment for acute cholecystitis (AC) although it is always not suitable for patients who are poor candidates for surgery [ ]. In 2001 Giovannini et al. described the first EUS-guided biliary drainage (EUS-BD) through a transduodenal access with a needle knife. Subsequently, EUS-BD has considerably evolved thanks to the development of dedicated devices such as lumen apposing metal stents (LAMS), specifically designed for endoscopic ultrasound procedures. LAMS are made up of braided nitinol, that is fully covered with silicone to prevent tissue ingrowth, with wide flanges on both ends to provide anchorage.
Recently, LAMS have been incorporated into a delivery system with an electrocautery mounted on the tip which allows the device to be used directly to penetrate the target structure without the need to utilize a 19G needle, a guidewire, and a cystotome for prior dilation. Different are actually the indication of the LAMS for different disease and its use has been described for drainage of peri-pancreatic fluid collections, common bile duct (CBD), gallbladder, and for creation of gastro-jejuno anastomosis.
Read more
Recently, endoscopic gallbladder (GB) drainage was found to be a potentially revolutionary alternative for cholecystectomy for the control of symptoms, definitive treatment, or bridging therapy until surgery is possible.
Before the advent of LAMS, the standard of care of acute cholecystitis (AC) was the percutaneous drainage (PTC) and after the advent of these new stents, different series showed the higher technical and clinical success of the EUS-gallbladder drainage (EUS-GB) for acute cholecystitis, with a lower recurrence rate, than PTC. The superiority of this technique was assessed in terms of technical and clinical success, AEs and AC recurrence if compared to the endoscopic drainage. This could be explained with the use of larger caliber stents, allowing an effective drainage, with low risk of stent occlusion. Finally, a recent study with a long-term follow-up showed as the outcomes of EUS-GBD for AC were comparable with LC with acceptable rates of recurrent acute cholecystitis.
- Conditions
- Acute Cholecystitis
- Being tested
- EUS-biliary drainage
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-biliary drainageProcedure or surgery
EUS-GBD with LAMS
| Study group | Role | What they receive |
|---|---|---|
| Acute cholecystitis | Not described Receives: Procedure: EUS-biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of EUS-GBD
The rate of successful LAMS placement in the targeted organ
Measured: 2 years
Clinical success of EUS-GBD
The clinical resolution of the Acute cholecystitis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start28 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas Mater Domini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272007
- Sponsor's protocol ID
- 06-2022
- Acronym
- AC LAMS
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasonography (EUS) Guided Gallbladder Drainage With Two Months Stent Removal for Acute Cholecystitis: a Prospective Study
- ClinicalTrials.gov ID
- NCT05272007
- Acronym / sponsor ID
- AC LAMS / 06-2022
- Conditions
- Acute Cholecystitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Clinico Humanitas Mater DominiUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Mar 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.
Acute cholecystitis (AC) is defined as an acute inflammatory disease of the gallbladder consequently to the presence of sludge or stones. AC accounts for 3-10% of all cases of abdominal pain. Cholecystolithiasis accounts for 90-95% of all causes of acute cholecystitis, while acalculous cholecystitis accounts for the remaining 5-10% of the cases. Laparoscopic cholecystectomy is actually the gold standard treatment for acute cholecystitis (AC) although it is always not suitable for patients who are poor candidates for surgery [ ]. In 2001 Giovannini et al. described the first EUS-guided biliary drainage (EUS-BD) through a transduodenal access with a needle knife. Subsequently, EUS-BD has considerably evolved thanks to the development of dedicated devices such as lumen apposing metal stents (LAMS), specifically designed for endoscopic ultrasound procedures. LAMS are made up of braided nitinol, that is fully covered with silicone to prevent tissue ingrowth, with wide flanges on both ends to provide anchorage.
Recently, LAMS have been incorporated into a delivery system with an electrocautery mounted on the tip which allows the device to be used directly to penetrate the target structure without the need to utilize a 19G needle, a guidewire, and a cystotome for prior dilation. Different are actually the indication of the LAMS for different disease and its use has been described for drainage of peri-pancreatic fluid collections, common bile duct (CBD), gallbladder, and for creation of gastro-jejuno anastomosis.
Recently, endoscopic gallbladder (GB) drainage was found to be a potentially revolutionary alternative for cholecystectomy for the control of symptoms, definitive treatment, or bridging therapy until surgery is possible.
Before the advent of LAMS, the standard of care of acute cholecystitis (AC) was the percutaneous drainage (PTC) and after the advent of these new stents, different series showed the higher technical and clinical success of the EUS-gallbladder drainage (EUS-GB) for acute cholecystitis, with a lower recurrence rate, than PTC. The superiority of this technique was assessed in terms of technical and clinical success, AEs and AC recurrence if compared to the endoscopic drainage. This could be explained with the use of larger caliber stents, allowing an effective drainage, with low risk of stent occlusion. Finally, a recent study with a long-term follow-up showed as the outcomes of EUS-GBD for AC were comparable with LC with acceptable rates of recurrent acute cholecystitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute cholecystitis | – | Procedure: EUS-biliary drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is an observational multicentric prospective study. Data from consecutive patients with AC will be evaluated and, if eligible and agreed to participate, will be recorded in an electronic register. Patients will be followed until death or for at least 1 year after stent removal.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patients arrived to the ER for AC with clinical and radiological evidence of AC (such as abdominal ultrasound, computed tomography or magnetic resonance)
- EUS gallbladder accessibility from the duodenum or from the stomach for the drainage
- Agree to receive follow up phone calls
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000
- Use of anticoagulants that cannot be discontinued
- Pregnant women
- Inability to sign the informed consent
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 |
|---|---|---|
| EUS-biliary drainageEUS-GBD with LAMS | Procedure or surgery | Acute cholecystitis |
Primary outcome
Technical success of EUS-GBD
Time frame: 2 years
The rate of successful LAMS placement in the targeted organ
Clinical success of EUS-GBD
Time frame: 2 years
The clinical resolution of the Acute cholecystitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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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.
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 Acute Cholecystitis, run by Istituto Clinico Humanitas Mater Domini at 1 site in Italy.
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 5 inclusion and 4 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 1 Apr 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 Italy. 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 Benedetto Mangiavillano, MD ((+39) 0331 476205 - 381, benedetto.mangiavillano@mc.humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of EUS-GBD (time frame: 2 years). The study lists 2 primary outcomes in all. 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 1 Apr 2022.