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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Humanitas-Mater Domini

    Castellanza, 21053

    Benedetto Mangiavillano, MD, (+39) 0331 476205 - 381, benedetto.mangiavillano@mc.humanitas.it

    Recruiting

Other trials in Italy

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.

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 groups in NCT05272007
Study groupRoleWhat they receive
Acute cholecystitisNot described
Receives: Procedure: EUS-biliary drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical success of EUS-GBD

    The rate of successful LAMS placement in the targeted organ

    Measured: 2 years

  2. 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.

  1. First posted9 Mar 2022
  2. Study start28 Feb 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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

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.

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