CholecystectomyNCT07400237
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy
A study testing Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) in people with Cholecystectomy, run by Consorci Sanitari Integral at 1 site in Spain.
Trial summary
This is a multicenter, prospective, interventional clinical trial designed to evaluate and compare two intraoperative imaging modalities: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years.
- Written informed consent provided.
- Indication for laparoscopic cholecystectomy with anticipated technical difficulty due to one or more of the following:
- Acute cholecystitis.
- Previous cholangitis, pancreatitis, or endoscopic retrograde cholangiopancreatography.
- Prior upper abdominal surgery.
- Obesity (Body Mass Index ≥ 30 kg/m²).
Who cannot join
- Known allergy to ICG or iodine.
- Pregnancy or breastfeeding.
- High risk of choledocholithiasis (ESGE guidelines).
- Thyroid disease.
- Suspected gallbladder malignancy.
- ASA class IV-V.
- Chronic kidney disease stage > IIIb.
- Planned open cholecystectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sergio González Martínez, M.D., Ph.D. contact
Spain1 site, 1 recruiting
- Recruiting
Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
Sant Joan Despí, Barcelona, 08970
Andrea Sanz Llorente, M.D., +34 935531200, andreasanz@uic.es
About this study
Official title: Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study
This is a multicenter, prospective, interventional clinical trial designed to evaluate and compare two intraoperative imaging modalities: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection.
The primary endpoint is the successful identification of the critical junction. Secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, intraoperative and postoperative complications.
- Conditions
- Cholecystectomy
- Being tested
- Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)
- Keywords
- laparoscopic cholecystectomy, laparoscopic ultrasound, fluorescence cholangiography, indocyanine green, biliary injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)Diagnostic test
Two intraoperative imaging modalities will be applied: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection.
| Study group | Role | What they receive |
|---|---|---|
| Complex laparoscopic cholecystectomy | Other | Laparoscopic cholecystectomy with anticipated technical difficulty Receives: Diagnostic Test: Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct
This intraoperative visualization will be assessed separately for laparoscopic ultrasound (LUS) and indocyanine green fluorescence cholangiography (ICG) and recorded as a binary outcome (yes/no) for each technique in each patient using a standardized intraoperative assessment form completed by the operating surgeon.
Laparoscopic ultrasound will be performed first, followed by indocyanine green fluorescence cholangiography, according to a predefined and standardized intraoperative sequence.
Intraoperative photographic documentation will be obtained for each imaging modality to objectively demonstrate the visualization of the critical biliary junction.
Results will be reported as the proportion of patients with successful visualization for each modality and compared using an intra-subject analysis.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Moisés Broggi de Sant Joan Despí, Barcelona, Hospital Clínico Universitario de Valencia, Hospital Germans Tríes i Pujol de Badalona, Hospital Joan XXIII, Tarragona, Consorcio Parc de Salut Mar, Hospital del Mar, Hospital Mutua de Terrassa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400237
- Sponsor's protocol ID
- 24/49
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study
- ClinicalTrials.gov ID
- NCT07400237
- Acronym / sponsor ID
- 24/49
- Conditions
- Cholecystectomy
- Keywords
- laparoscopic cholecystectomy, laparoscopic ultrasound, fluorescence cholangiography, indocyanine green, biliary injury prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Collaborators
- Hospital Moisés Broggi de Sant Joan Despí, Barcelona, Hospital Clínico Universitario de Valencia, Hospital Germans Tríes i Pujol de Badalona, Hospital Joan XXIII, Tarragona, Consorcio Parc de Salut Mar, Hospital del Mar, Hospital Mutua de Terrassa
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Feb 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 is a multicenter, prospective, interventional clinical trial designed to evaluate and compare two intraoperative imaging modalities: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection.
The primary endpoint is the successful identification of the critical junction. Secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, intraoperative and postoperative complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex laparoscopic cholecystectomy | Other | Diagnostic Test: Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)Laparoscopic cholecystectomy with anticipated technical difficulty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Written informed consent provided.
- Indication for laparoscopic cholecystectomy with anticipated technical difficulty due to one or more of the following:
Key exclusion criteria (8 listed)
- Known allergy to ICG or iodine.
- Pregnancy or breastfeeding.
- High risk of choledocholithiasis (ESGE guidelines).
- Thyroid disease.
- Suspected gallbladder malignancy.
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 |
|---|---|---|
| Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)Two intraoperative imaging modalities will be applied: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection. | Diagnostic test | Complex laparoscopic cholecystectomy |
Primary outcome
Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct
Time frame: Intraoperative
This intraoperative visualization will be assessed separately for laparoscopic ultrasound (LUS) and indocyanine green fluorescence cholangiography (ICG) and recorded as a binary outcome (yes/no) for each technique in each patient using a standardized intraoperative assessment form completed by the operating surgeon. Laparoscopic ultrasound will be performed first, followed by indocyanine green fluorescence cholangiography, according to a predefined and standardized intraoperative sequence. Intraoperative photographic documentation will be obtained for each imaging modality to objectively demonstrate the visualization of the critical biliary junction. Results will be reported as the proportion of patients with successful visualization for each modality and compared using an intra-subject analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Sergio González Martínez, M.D., Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) in people with Cholecystectomy, run by Consorci Sanitari Integral at 1 site in Spain.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Feb 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Sanz LLorente, M.D. (+34 93 5531200, andreasanz@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct (time frame: Intraoperative). 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 2026.