Cholecystitis, AcuteNCT07704021
Safety and Efficacy of EUS-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation
An observational study of Cholecystitis, Acute and Pancreas Cancer, Duct Cell Adenocarcinoma, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial summary
This prospective single-center study was designed by the investigators to evaluate the feasibility, safety, and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) performed under endoscopist-directed conscious sedation in elderly, high-risk patients with acute cholecystitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute, Pancreas Cancer, Duct Cell Adenocarcinoma, Cholangiocarcinoma
- What is being tested?
- Sedation
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 30 Jun 2026
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients undergoing EUS-GBD under conscious sedation at our tertiary referral center between January 2020 and October 2024 were prospectively enrolled.
Who may be able to join
- acute cholecystitis in patients considered unfit for surgery according to ASA Physical Status classification and clinical judgment.
Who cannot join
- age <18 years
- patients with acute cholecystitis fit for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Endoscopic Ultrasound-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation: a Prospective Study
This prospective single-center study was designed by the investigators to evaluate the feasibility, safety, and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) performed under endoscopist-directed conscious sedation in elderly, high-risk patients with acute cholecystitis. The study aims to assess whether conscious sedation represents a viable alternative to deep sedation or general anesthesia in this fragile patient population.
Read the detailed description
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has emerged as an effective minimally invasive treatment for acute cholecystitis in patients who are poor surgical candidates. Although the procedure is commonly performed under deep sedation or general anesthesia, many patients eligible for EUS-GBD are elderly and have significant comorbidities, making anesthesia management particularly challenging. Data regarding the use of endoscopist-directed conscious sedation for EUS-GBD remain limited.
The investigators designed this prospective single-center study to evaluate the feasibility, safety, and efficacy of EUS-GBD performed under endoscopist-directed conscious sedation in a cohort of elderly, high-risk patients with acute cholecystitis. The study focuses on procedural outcomes and sedation management, with particular attention to ketamine-based conscious sedation as a potential strategy for minimizing anesthesia-related risks in this vulnerable population.
- Being tested
- Sedation
- Keywords
- gallbladder endoscopic ultrasound-guided drainage, sedation, acute cholecystitis
- Medical subject headings
- Cholecystitis, Acute, Pancreatic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedationDrug
Also called endoscopic ultrasound- guided gallbladder drainage
Performing endoscopic ultrasound-guided gallbladder drainage under endoscopist-directed conscious sedation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage
Sedation-related adverse events occurring during or immediately after the procedure, including oxygen desaturation (SpO₂ <90%), hypotension requiring intervention, bradycardia, need for airway support, unplanned conversion to deep sedation or general anesthesia, and procedure interruption due to sedation-related complications.
Measured: from April 2022 to April 2028
Secondary outcomes (1)
Number of participants with procedure-related adverse events
Procedure-related adverse events occurring during or within 30 days after EUS-guided gallbladder drainage, classified according to the ASGE lexicon and graded by severity.
Measured: April 2022-2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Apr 2022
- Primary completion1 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies 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
- 48 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cominardi, Azienda Unita Sanitaria Locale di Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704021
- Sponsor's protocol ID
- PC01
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 15 Jul 2026
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopic Ultrasound-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation: a Prospective Study
- ClinicalTrials.gov ID
- NCT07704021
- Acronym / sponsor ID
- PC01
- Keywords
- gallbladder endoscopic ultrasound-guided drainage, sedation, acute cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 15 Jul 2026 (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.
This prospective single-center study was designed by the investigators to evaluate the feasibility, safety, and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) performed under endoscopist-directed conscious sedation in elderly, high-risk patients with acute cholecystitis. The study aims to assess whether conscious sedation represents a viable alternative to deep sedation or general anesthesia in this fragile patient population.
Detailed description
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has emerged as an effective minimally invasive treatment for acute cholecystitis in patients who are poor surgical candidates. Although the procedure is commonly performed under deep sedation or general anesthesia, many patients eligible for EUS-GBD are elderly and have significant comorbidities, making anesthesia management particularly challenging. Data regarding the use of endoscopist-directed conscious sedation for EUS-GBD remain limited.
The investigators designed this prospective single-center study to evaluate the feasibility, safety, and efficacy of EUS-GBD performed under endoscopist-directed conscious sedation in a cohort of elderly, high-risk patients with acute cholecystitis. The study focuses on procedural outcomes and sedation management, with particular attention to ketamine-based conscious sedation as a potential strategy for minimizing anesthesia-related risks in this vulnerable population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients undergoing EUS-GBD under conscious sedation at our tertiary referral center between January 2020 and October 2024 were prospectively enrolled.
Key inclusion criteria (1 listed)
- acute cholecystitis in patients considered unfit for surgery according to ASA Physical Status classification and clinical judgment.
Key exclusion criteria (2 listed)
- age <18 years
- patients with acute cholecystitis fit for surgery
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 |
|---|---|---|
| SedationAlso: endoscopic ultrasound- guided gallbladder drainagePerforming endoscopic ultrasound-guided gallbladder drainage under endoscopist-directed conscious sedation. | Drug | – |
Primary outcome
Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage
Time frame: from April 2022 to April 2028
Sedation-related adverse events occurring during or immediately after the procedure, including oxygen desaturation (SpO₂ <90%), hypotension requiring intervention, bradycardia, need for airway support, unplanned conversion to deep sedation or general anesthesia, and procedure interruption due to sedation-related complications.
1 secondary outcome
Number of participants with procedure-related adverse events
Time frame: April 2022-2028
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cholecystitis, Acute and Pancreas Cancer, Duct Cell Adenocarcinoma, run by Azienda Unita Sanitaria Locale di Piacenza 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage (time frame: from April 2022 to April 2028). 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 15 Jul 2026.