Cholecystitis, AcuteEPIC-GBDNCT07575360
PT-GBD to EUS-GBD Conversion Versus Standard Management in High-Risk Acute Cholecystitis Patients
An observational study of Cholecystitis, Acute, run by University of Bologna at 1 site in Italy.
Trial summary
Acute cholecystitis in high-risk surgical patients is commonly managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). However, long-term adverse events, tube dysfunction, and recurrent cholecystitis remain significant concerns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD) and Standard cholecystostomy (PT-GBD) management
- Type of treatment
- Surgery or procedure
- How many people
- 484 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 30 Sep 2025
- 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: The study population includes adult patients (≥18 years) with acute cholecystitis who were considered high-risk for surgery and managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). All patients were deemed unfit for cholecystectomy after multidisciplinary evaluation. Eligible patients are retrospectively identified from participating centers and include all consecutive cases undergoing PT-GBD during the study period. The population reflects a real-world cohort of frail patients with significant comorbidities. Two groups are defined based on subsequent management: conversion to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stent (LAMS) versus standard management.
Who may be able to join
- Age >18 years
- Patients considered unfit for surgery after multidisciplinary discussion
- Patients who underwent PT-GBD for acute cholecystitis
Who cannot join
- Patients with improved general conditions who become fit for laparoscopic cholecystectomy
- Use of anticoagulants that cannot be discontinued
- Coagulation and/or platelet hereditary disorders and/or INR >1.5, PLT <50,000
- Absolute contraindication for EUS-GBD
- Post-surgical altered upper gastrointestinal anatomy
- Malignant biliary obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conversion to Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) Versus Standard Management of High-Risk Surgical Patients Who Underwent Percutaneous Trans-Hepatic Gallbladder Drainage (PT-GBD) for Acute Cholecystitis
Acute cholecystitis in high-risk surgical patients is commonly managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). However, long-term adverse events, tube dysfunction, and recurrent cholecystitis remain significant concerns. This retrospective multicenter observational study compares long-term outcomes of conversion from PT-GBD to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMS) versus standard management in high-risk surgical patients with acute cholecystitis.
Read the detailed description
Acute cholecystitis is a common and potentially severe condition that often requires timely intervention, particularly in high-risk surgical patients who are not suitable candidates for cholecystectomy. In this population, percutaneous trans-hepatic gallbladder drainage (PT-GBD) is widely used as an effective minimally invasive treatment, providing rapid clinical improvement and high technical success rates. However, despite its short-term efficacy, PT-GBD is associated with significant long-term limitations, including tube dysfunction or dislodgement, patient discomfort related to the external catheter, and a relatively high incidence of recurrent cholecystitis and other adverse events.
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has emerged as an alternative minimally invasive approach that allows internalization of gallbladder drainage. This technique has the potential to improve patient quality of life, reduce catheter-related complications, and decrease the incidence of recurrent biliary events. Conversion from PT-GBD to EUS-GBD has been proposed as a strategy to overcome the limitations of long-term percutaneous drainage. Preliminary evidence suggests that such a conversion is technically feasible and associated with favorable clinical outcomes, including reduced adverse events and improved long-term management.
Nevertheless, the available literature is limited, and comparative data between conversion to EUS-GBD using LAMS and standard management after PT-GBD are scarce. In particular, only a limited number of studies have specifically evaluated outcomes following conversion with LAMS, and no large comparative studies have definitively assessed its impact on long-term adverse events and clinical outcomes.
This multicenter retrospective observational study aims to compare the long-term outcomes of two management strategies in high-risk surgical patients with acute cholecystitis who previously underwent PT-GBD: (1) conversion to EUS-GBD using LAMS and (2) standard management without conversion. All consecutive eligible patients treated with PT-GBD will be retrospectively identified and included according to predefined inclusion and exclusion criteria.
The primary objective of the study is to evaluate the incidence of adverse events at 1 year in patients undergoing PT-GBD to EUS-GBD conversion compared with those receiving standard management. Secondary objectives include the assessment of technical success, clinical success, procedural adverse events, 30-day adverse events, 1-year incidence of stent dysfunction, biliary adverse events, recurrent cholecystitis, biliary reintervention rate, readmission rate, biliary-related mortality, and overall survival.
Data will be collected from participating centers using standardized case report forms, including demographic characteristics, clinical variables, procedural details, and follow-up outcomes. Patients will be followed for at least 1 year to assess the occurrence of adverse events and other clinical endpoints.
The study is conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Approval from the relevant Ethics Committees will be obtained at each participating center prior to data collection.
- Conditions
- Cholecystitis, Acute
- Being tested
- EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD), Standard cholecystostomy (PT-GBD) management
- Keywords
- PT-GBD, EUS-GBD, LAMS, ERCP, Conversion, Cholecystostomy
- 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-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD)Procedure or surgery
Patients included in the intervention group are high-risk surgical patients with acute cholecystitis who previously underwent percutaneous trans-hepatic gallbladder drainage (PT-GBD) and subsequently underwent conversion to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS).
The procedure is performed under endoscopic ultrasound (EUS) guidance using a linear echoendoscope to identify the gallbladder from the gastric or duodenal lumen. After confirming the absence of intervening vessels using Doppler imaging, the gallbladder is accessed and a LAMS delivery system is advanced to create a fistulous tract between the gallbladder and the gastrointestinal lumen (either transgastric or transduodenal approach). The LAMS is then deployed to allow internal drainage of gallbladder contents into the gastrointestinal tract.
Standard cholecystostomy (PT-GBD) managementProcedure or surgery
Patients in the comparator group are high-risk surgical patients with acute cholecystitis who underwent PT-GBD and continued with standard management without conversion to EUS-GBD.
Standard management consists of maintenance of the percutaneous trans-hepatic gallbladder drainage catheter, including routine care, monitoring, and management according to institutional clinical practice. This may include periodic catheter exchanges, management of catheter-related complications, and clinical follow-up.
In selected cases, removal of the percutaneous drain may be considered if clinically indicated, based on resolution of symptoms and treating physician judgment. However, no internal drainage via EUS-guided techniques is performed in this group.
| Study group | Role | What they receive |
|---|---|---|
| Standard cholecystostomy (PT-GBD) management | High-risk surgical patients with acute cholecystitis who underwent PT-GBD and received standard management without conversion to EUS-GBD. Receives: Procedure: Standard cholecystostomy (PT-GBD) management | |
| EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD) | High-risk surgical patients with acute cholecystitis who previously underwent PT-GBD and were subsequently converted to EUS-guided gallbladder drainage with LAMS. Receives: Procedure: EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent acute cholecystitis
Any clinical, biochemical or radiological recurrence of acute cholecystitis, defined according to Tokyo guidelines 2018 criteria
Measured: 12-month
Secondary outcomes (5)
Biliary reintervention
Any planned or unplanned biliary reintervention (stent revision, replacement, ERCP, EUS, etc.) required during the 1-year follow-up
Measured: 12-month
Biliary-related mortality
Patient's death caused by any biliary-related disease, complication or adverse event.
Measured: 12-month
Overall mortality
Patient's death for any cause
Measured: 12-month
Readmission
Patient's hospital admission for any cause during the follow-up period
Measured: 12-month
Technical success
Adequate stent placement during internalization of cholecystostomy (limited to the intervention group)
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Apr 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Fusaroli, University of Bologna
- Investigators
- Pietro Fusaroli, Professor, Study director, University of Bologna, Hospital of ImolaAndrea Lisotti, MD, Principal investigator, Hospital of Imola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575360
- Sponsor's protocol ID
- 233-2024-OSS-AUSLIM
- Acronym
- EPIC-GBD
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves retrospective data collected and data sharing is limited by institutional policies and data protection regulations. De-identified aggregate data may be made available upon reasonable request to the corresponding author, subject to approval by the study investigators and participating centers.
Publications
Law R, Grimm IS, Stavas JM, Baron TH. Conversion of Percutaneous Cholecystostomy to Internal Transmural Gallbladder Drainage Using an Endoscopic Ultrasound-Guided, Lumen-Apposing Metal Stent. Clin Gastroenterol Hepatol. 2016 Mar;14(3):476-80. doi: 10.1016/j.cgh.2015.10.026. Epub 2015 Oct 31.
PubMed 26528802Minaga K, Yamashita Y, Ogura T, Takenaka M, Shimokawa Y, Hisa T, Itonaga M, Kato H, Nishikiori H, Okuda A, Matsumoto H, Uenoyama Y, Watanabe T, Chiba Y, Higuchi K, Kudo M, Kitano M. Clinical efficacy and safety of endoscopic ultrasound-guided gallbladder drainage replacement of percutaneous drainage: A multicenter retrospective study. Dig Endosc. 2019 Mar;31(2):180-187. doi: 10.1111/den.13242. Epub 2018 Aug 27.
PubMed 30039611Teoh AYB, Kitano M, Itoi T, Perez-Miranda M, Ogura T, Chan SM, Serna-Higuera C, Omoto S, Torres-Yuste R, Tsuichiya T, Wong KT, Leung CH, Chiu PWY, Ng EKW, Lau JYW. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12.
PubMed 32165407
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion to Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) Versus Standard Management of High-Risk Surgical Patients Who Underwent Percutaneous Trans-Hepatic Gallbladder Drainage (PT-GBD) for Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT07575360
- Acronym / sponsor ID
- EPIC-GBD / 233-2024-OSS-AUSLIM
- Conditions
- Cholecystitis, Acute
- Keywords
- PT-GBD, EUS-GBD, LAMS, ERCP, Conversion, Cholecystostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 May 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.
Acute cholecystitis in high-risk surgical patients is commonly managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). However, long-term adverse events, tube dysfunction, and recurrent cholecystitis remain significant concerns. This retrospective multicenter observational study compares long-term outcomes of conversion from PT-GBD to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMS) versus standard management in high-risk surgical patients with acute cholecystitis.
Detailed description
Acute cholecystitis is a common and potentially severe condition that often requires timely intervention, particularly in high-risk surgical patients who are not suitable candidates for cholecystectomy. In this population, percutaneous trans-hepatic gallbladder drainage (PT-GBD) is widely used as an effective minimally invasive treatment, providing rapid clinical improvement and high technical success rates. However, despite its short-term efficacy, PT-GBD is associated with significant long-term limitations, including tube dysfunction or dislodgement, patient discomfort related to the external catheter, and a relatively high incidence of recurrent cholecystitis and other adverse events.
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has emerged as an alternative minimally invasive approach that allows internalization of gallbladder drainage. This technique has the potential to improve patient quality of life, reduce catheter-related complications, and decrease the incidence of recurrent biliary events. Conversion from PT-GBD to EUS-GBD has been proposed as a strategy to overcome the limitations of long-term percutaneous drainage. Preliminary evidence suggests that such a conversion is technically feasible and associated with favorable clinical outcomes, including reduced adverse events and improved long-term management.
Nevertheless, the available literature is limited, and comparative data between conversion to EUS-GBD using LAMS and standard management after PT-GBD are scarce. In particular, only a limited number of studies have specifically evaluated outcomes following conversion with LAMS, and no large comparative studies have definitively assessed its impact on long-term adverse events and clinical outcomes.
This multicenter retrospective observational study aims to compare the long-term outcomes of two management strategies in high-risk surgical patients with acute cholecystitis who previously underwent PT-GBD: (1) conversion to EUS-GBD using LAMS and (2) standard management without conversion. All consecutive eligible patients treated with PT-GBD will be retrospectively identified and included according to predefined inclusion and exclusion criteria.
The primary objective of the study is to evaluate the incidence of adverse events at 1 year in patients undergoing PT-GBD to EUS-GBD conversion compared with those receiving standard management. Secondary objectives include the assessment of technical success, clinical success, procedural adverse events, 30-day adverse events, 1-year incidence of stent dysfunction, biliary adverse events, recurrent cholecystitis, biliary reintervention rate, readmission rate, biliary-related mortality, and overall survival.
Data will be collected from participating centers using standardized case report forms, including demographic characteristics, clinical variables, procedural details, and follow-up outcomes. Patients will be followed for at least 1 year to assess the occurrence of adverse events and other clinical endpoints.
The study is conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Approval from the relevant Ethics Committees will be obtained at each participating center prior to data collection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cholecystostomy (PT-GBD) management | – | Procedure: Standard cholecystostomy (PT-GBD) managementHigh-risk surgical patients with acute cholecystitis who underwent PT-GBD and received standard management without conversion to EUS-GBD. |
| EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD) | – | Procedure: EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD)High-risk surgical patients with acute cholecystitis who previously underwent PT-GBD and were subsequently converted to EUS-guided gallbladder drainage with LAMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients (≥18 years) with acute cholecystitis who were considered high-risk for surgery and managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). All patients were deemed unfit for cholecystectomy after multidisciplinary evaluation. Eligible patients are retrospectively identified from participating centers and include all consecutive cases undergoing PT-GBD during the study period. The population reflects a real-world cohort of frail patients with significant comorbidities. Two groups are defined based on subsequent management: conversion to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stent (LAMS) versus standard management.
Key inclusion criteria (3 listed)
- Age >18 years
- Patients considered unfit for surgery after multidisciplinary discussion
- Patients who underwent PT-GBD for acute cholecystitis
Key exclusion criteria (6 listed)
- Patients with improved general conditions who become fit for laparoscopic cholecystectomy
- Use of anticoagulants that cannot be discontinued
- Coagulation and/or platelet hereditary disorders and/or INR >1.5, PLT <50,000
- Absolute contraindication for EUS-GBD
- Post-surgical altered upper gastrointestinal anatomy
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-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD)Patients included in the intervention group are high-risk surgical patients with acute cholecystitis who previously underwent percutaneous trans-hepatic gallbladder drainage (PT-GBD) and subsequently underwent conversion to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). The procedure is performed under endoscopic ultrasound (EUS) guidance using a linear echoendoscope to identify the gallbladder from the gastric or duodenal lumen. After confirming the absence of intervening vessels using Doppler imaging, the gallbladder is accessed and a LAMS delivery system is advanced to create a fistulous tract between the gallbladder and the gastrointestinal lumen (either transgastric or transduodenal approach). The LAMS is then deployed to allow internal drainage of gallbladder contents into the gastrointestinal tract. | Procedure or surgery | EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD) |
| Standard cholecystostomy (PT-GBD) managementPatients in the comparator group are high-risk surgical patients with acute cholecystitis who underwent PT-GBD and continued with standard management without conversion to EUS-GBD. Standard management consists of maintenance of the percutaneous trans-hepatic gallbladder drainage catheter, including routine care, monitoring, and management according to institutional clinical practice. This may include periodic catheter exchanges, management of catheter-related complications, and clinical follow-up. In selected cases, removal of the percutaneous drain may be considered if clinically indicated, based on resolution of symptoms and treating physician judgment. However, no internal drainage via EUS-guided techniques is performed in this group. | Procedure or surgery | Standard cholecystostomy (PT-GBD) management |
Primary outcome
Recurrent acute cholecystitis
Time frame: 12-month
Any clinical, biochemical or radiological recurrence of acute cholecystitis, defined according to Tokyo guidelines 2018 criteria
5 secondary outcomes
Biliary reintervention
Time frame: 12-month
Biliary-related mortality
Time frame: 12-month
Overall mortality
Time frame: 12-month
Readmission
Time frame: 12-month
Technical success
Time frame: Periprocedural
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 8 May 2026.
- Background: PubMed 26528802Law R, Grimm IS, Stavas JM, Baron TH. Conversion of Percutaneous Cholecystostomy to Internal Transmural Gallbladder Drainage Using an Endoscopic Ultrasound-Guided, Lumen-Apposing Metal Stent. Clin Gastroenterol Hepatol. 2016 Mar;14(3):476-80. doi: 10.1016/j.cgh.2015.10.026. Epub 2015 Oct 31.
- Background: PubMed 30039611Minaga K, Yamashita Y, Ogura T, Takenaka M, Shimokawa Y, Hisa T, Itonaga M, Kato H, Nishikiori H, Okuda A, Matsumoto H, Uenoyama Y, Watanabe T, Chiba Y, Higuchi K, Kudo M, Kitano M. Clinical efficacy and safety of endoscopic ultrasound-guided gallbladder drainage replacement of percutaneous drainage: A multicenter retrospective study. Dig Endosc. 2019 Mar;31(2):180-187. doi: 10.1111/den.13242. Epub 2018 Aug 27.
- Background: PubMed 32165407Teoh AYB, Kitano M, Itoi T, Perez-Miranda M, Ogura T, Chan SM, Serna-Higuera C, Omoto S, Torres-Yuste R, Tsuichiya T, Wong KT, Leung CH, Chiu PWY, Ng EKW, Lau JYW. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study involves retrospective data collected and data sharing is limited by institutional policies and data protection regulations. De-identified aggregate data may be made available upon reasonable request to the corresponding author, subject to approval by the study investigators and participating centers.
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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.
Pietro Fusaroli, Professor study director
University of Bologna, Hospital of Imola
Andrea Lisotti, MD principal investigator
Hospital of Imola
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, run by University of Bologna 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 3 inclusion and 6 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 8 May 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?
Recurrent acute cholecystitis (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07575360, which also lists 3 linked publications.
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 8 May 2026.