Acute CholecystitisICG-ACBCNCT07481760
Acute Cholecystitis Biliary Complications - ICG
A study testing ICG in people with Acute Cholecystitis and Biliary Complications, run by Hospital del Mar at 1 site in Spain.
Trial summary
Acute cholecystitis is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis, Biliary Complications
- What is being tested?
- ICG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2027to 31 Mar 2029
- 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.
- Diagnosis of acute cholecystitis according to Tokyo Guidelines (TG18) criteria.
- Planned urgent/emergency laparoscopic cholecystectomy during the index admission, as determined by the treating surgical team.
- Ability to provide written informed consent prior to surgery.
Who cannot join
- Known hypersensitivity or contraindication to indocyanine green (ICG) or its excipients.
- Pregnancy or breastfeeding.
- Clinical situation preventing protocol implementation or informed consent (e.g., life-threatening emergency requiring immediate surgery without time for study procedures).
- Primary open cholecystectomy planned (i.e., not intended laparoscopic approach).
- Any condition that, in the investigator's opinion, makes participation unsafe or not feasible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ana Maria Gonzalez Castillo, ACBC Trial Ppal Investigator contact
Spain1 site
Ana Maria Gonzalez Castillo
Cerdanyola del Vallès, Barcelona, 08290
Ana Maria Gonzalez Castillo, 665126866, amgonzalezcastillo@gmail.com
About this study
Official title: Multicenter Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence to Reduce Biliary Complications in Emergency Cholecystectomy for Acute Cholecystitis
Acute cholecystitis is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Indocyanine green (ICG) fluorescence cholangiography allows real-time visualization of the extrahepatic biliary anatomy using near-infrared imaging and has shown to improve anatomical identification during elective cholecystectomy. However, its clinical impact in the emergency setting of acute cholecystitis has not been adequately evaluated in randomized multicenter trials.
The objective of this study is to determine whether the use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy reduces the incidence of clinically relevant biliary complications compared with standard surgery without ICG.
This is a pragmatic, multicenter, open-label randomized controlled trial including 296 adult patients with acute cholecystitis undergoing urgent laparoscopic cholecystectomy. Participants will be randomized 1:1 to surgery with or without ICG fluorescence guidance. The primary outcome is the incidence of clinically relevant biliary complications, including bile duct injury or bile leak, within 90 days after surgery.
Read the detailed description
Acute cholecystitis is one of the most common indications for emergency abdominal surgery. Early laparoscopic cholecystectomy is considered the standard treatment; however, inflammation and distorted anatomy may make identification of the biliary structures challenging, increasing the risk of bile duct injury or bile leak. These complications are associated with significant morbidity, need for additional procedures, prolonged hospitalization, and increased healthcare costs.
Indocyanine green (ICG) fluorescence cholangiography is an intraoperative imaging technique that allows real-time visualization of the extrahepatic biliary anatomy using near-infrared fluorescence. After intravenous administration, ICG is rapidly excreted into bile, enabling enhanced visualization of the biliary tree during laparoscopic surgery. Several studies in elective laparoscopic cholecystectomy have demonstrated that ICG fluorescence improves anatomical identification and may increase surgical safety. However, evidence regarding its effectiveness in the emergency setting of acute cholecystitis remains limited, and high-quality multicenter randomized controlled trials are lacking.
The ICG-ACBC Trial is designed to evaluate whether the systematic use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy for acute cholecystitis reduces the incidence of clinically relevant biliary complications compared with standard laparoscopic cholecystectomy without fluorescence guidance.
This study is a multicenter, pragmatic, open-label randomized controlled trial. A total of 296 adult patients diagnosed with acute cholecystitis according to Tokyo Guidelines criteria and requiring urgent laparoscopic cholecystectomy will be enrolled across participating hospitals. Participants will be randomized in a 1:1 ratio to undergo surgery either with intraoperative ICG fluorescence guidance or with standard laparoscopic cholecystectomy without ICG. Randomization will be centralized and stratified by participating center.
In the intervention group, patients will receive an intravenous dose of indocyanine green prior to surgery, and near-infrared imaging will be used intraoperatively to visualize the biliary anatomy. In the control group, patients will undergo standard laparoscopic cholecystectomy following established surgical principles, including the critical view of safety.
The primary outcome is the incidence of clinically relevant biliary complications, defined as bile duct injury or clinically significant bile leak, occurring within 90 days after surgery. Secondary outcomes include other perioperative complications, conversion to open surgery, length of hospital stay, reinterventions, readmissions, surgeon-reported visualization quality, and patient-reported outcomes.
The results of this study may provide high-quality evidence on whether routine use of ICG fluorescence cholangiography improves surgical safety in emergency cholecystectomy for acute cholecystitis and may inform future clinical guidelines and surgical practice.
- Conditions
- Acute Cholecystitis, Biliary Complications
- Being tested
- ICG
- Keywords
- acute cholecystitis, Laparoscopic Cholecystectomy, Indocyanine Green, Fluorescence Cholangiography, Bile Duct Injury, Biliary Complications, Emergency Surgery, Near-Infrared Fluorescence Imaging
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGOther
Emergency laparoscopic cholecystectomy performed with intraoperative indocyanine green fluorescence cholangiography to enhance visualization of the biliary anatomy.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | STANDARD CHOLECYSTECTOMY: laparoscopic cholecystectomy without the use of any contrast, just pure surgical anatomy. |
| INTERVENTION | Experimental | ICG CHOLECYSTECTOMY: laparoscopic cholecystectomy performed with indocyanine green fluorescence imaging, which allows visualization of the biliary tree to facilitate anatomical identification and reduce the risk of biliary complications. Receives: Other: ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Relevant Biliary Complications
Clinically relevant biliary complications defined as bile duct injury or clinically significant bile leak requiring therapeutic intervention. Bile leak will be defined according to the criteria of the International Study Group of Liver Surgery (ISGLS), and bile duct injury will be classified according to the Strasberg classification.
Measured: Within 90 days after surgery
Secondary outcomes (7)
Overall Postoperative Complications
Incidence of postoperative complications including bile leak, bile duct injury, bleeding, surgical site infection, intra-abdominal abscess, visceral or vascular injury, and reintervention. Complications will be graded according to the Clavien-Dindo classification and summarized using the Comprehensive Complication Index (CCI).
Measured: Within 90 days after surgery
Conversion to Open Surgery
Rate of conversion from laparoscopic to open cholecystectomy during surgery.
Measured: Day of the Surgery
Length of Hospital Stay
Postoperative hospital stay measured in days from surgery to hospital discharge.
Measured: Day 1 of admission
Readmission Rate
Unplanned hospital readmission related to the surgical procedure or postoperative complications.
Measured: Within 90 days after surgery
Quality of Biliary Anatomy Visualization (ICG group)
Qualitative assessment of intraoperative visualization of biliary structures (cystic duct, common bile duct, cystic duct-CBD junction, cystic artery, and common hepatic duct) using near-infrared fluorescence imaging. Visualization quality will be graded using a Likert scale.
Measured: Day of the Surgery
Surgeon-Reported Surgical Confidence
Surgeon-reported perception of anatomical clarity and confidence during dissection, measured using a structured postoperative questionnaire.
Measured: Day of the Surgery
Patient-Reported Outcomes (PROMs)
Patient-reported health status assessed using the EQ-5D-5L questionnaire.
Measured: 30 days and 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to undergo emergency laparoscopic cholecystectomy with indocyanine green fluorescence guidance or standard laparoscopic cholecystectomy without fluorescence imaging.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María González Castillo, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481760
- Sponsor's protocol ID
- ACBC TRIAL
- Acronym
- ICG-ACBC
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in publications from this study (after de-identification), including the study protocol, statistical analysis plan, and analytic code, may be shared with qualified researchers upon reasonable request. Requests will be reviewed by the principal investigator and the study steering committee to ensure that the proposed use is scientifically valid and ethically appropriate. Data will be made available after publication of the primary results and will require a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence to Reduce Biliary Complications in Emergency Cholecystectomy for Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT07481760
- Acronym / sponsor ID
- ICG-ACBC / ACBC TRIAL
- Conditions
- Acute Cholecystitis, Biliary Complications
- Keywords
- acute cholecystitis, Laparoscopic Cholecystectomy, Indocyanine Green, Fluorescence Cholangiography, Bile Duct Injury, Biliary Complications, Emergency Surgery, Near-Infrared Fluorescence Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 19 Mar 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 is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Indocyanine green (ICG) fluorescence cholangiography allows real-time visualization of the extrahepatic biliary anatomy using near-infrared imaging and has shown to improve anatomical identification during elective cholecystectomy. However, its clinical impact in the emergency setting of acute cholecystitis has not been adequately evaluated in randomized multicenter trials.
The objective of this study is to determine whether the use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy reduces the incidence of clinically relevant biliary complications compared with standard surgery without ICG.
This is a pragmatic, multicenter, open-label randomized controlled trial including 296 adult patients with acute cholecystitis undergoing urgent laparoscopic cholecystectomy. Participants will be randomized 1:1 to surgery with or without ICG fluorescence guidance. The primary outcome is the incidence of clinically relevant biliary complications, including bile duct injury or bile leak, within 90 days after surgery.
Detailed description
Acute cholecystitis is one of the most common indications for emergency abdominal surgery. Early laparoscopic cholecystectomy is considered the standard treatment; however, inflammation and distorted anatomy may make identification of the biliary structures challenging, increasing the risk of bile duct injury or bile leak. These complications are associated with significant morbidity, need for additional procedures, prolonged hospitalization, and increased healthcare costs.
Indocyanine green (ICG) fluorescence cholangiography is an intraoperative imaging technique that allows real-time visualization of the extrahepatic biliary anatomy using near-infrared fluorescence. After intravenous administration, ICG is rapidly excreted into bile, enabling enhanced visualization of the biliary tree during laparoscopic surgery. Several studies in elective laparoscopic cholecystectomy have demonstrated that ICG fluorescence improves anatomical identification and may increase surgical safety. However, evidence regarding its effectiveness in the emergency setting of acute cholecystitis remains limited, and high-quality multicenter randomized controlled trials are lacking.
The ICG-ACBC Trial is designed to evaluate whether the systematic use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy for acute cholecystitis reduces the incidence of clinically relevant biliary complications compared with standard laparoscopic cholecystectomy without fluorescence guidance.
This study is a multicenter, pragmatic, open-label randomized controlled trial. A total of 296 adult patients diagnosed with acute cholecystitis according to Tokyo Guidelines criteria and requiring urgent laparoscopic cholecystectomy will be enrolled across participating hospitals. Participants will be randomized in a 1:1 ratio to undergo surgery either with intraoperative ICG fluorescence guidance or with standard laparoscopic cholecystectomy without ICG. Randomization will be centralized and stratified by participating center.
In the intervention group, patients will receive an intravenous dose of indocyanine green prior to surgery, and near-infrared imaging will be used intraoperatively to visualize the biliary anatomy. In the control group, patients will undergo standard laparoscopic cholecystectomy following established surgical principles, including the critical view of safety.
The primary outcome is the incidence of clinically relevant biliary complications, defined as bile duct injury or clinically significant bile leak, occurring within 90 days after surgery. Secondary outcomes include other perioperative complications, conversion to open surgery, length of hospital stay, reinterventions, readmissions, surgeon-reported visualization quality, and patient-reported outcomes.
The results of this study may provide high-quality evidence on whether routine use of ICG fluorescence cholangiography improves surgical safety in emergency cholecystectomy for acute cholecystitis and may inform future clinical guidelines and surgical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to undergo emergency laparoscopic cholecystectomy with indocyanine green fluorescence guidance or standard laparoscopic cholecystectomy without fluorescence imaging.
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –STANDARD CHOLECYSTECTOMY: laparoscopic cholecystectomy without the use of any contrast, just pure surgical anatomy. |
| INTERVENTION | Experimental | Other: ICGICG CHOLECYSTECTOMY: laparoscopic cholecystectomy performed with indocyanine green fluorescence imaging, which allows visualization of the biliary tree to facilitate anatomical identification and reduce the risk of biliary complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Diagnosis of acute cholecystitis according to Tokyo Guidelines (TG18) criteria.
- Planned urgent/emergency laparoscopic cholecystectomy during the index admission, as determined by the treating surgical team.
- Ability to provide written informed consent prior to surgery.
Key exclusion criteria (5 listed)
- Known hypersensitivity or contraindication to indocyanine green (ICG) or its excipients.
- Pregnancy or breastfeeding.
- Clinical situation preventing protocol implementation or informed consent (e.g., life-threatening emergency requiring immediate surgery without time for study procedures).
- Primary open cholecystectomy planned (i.e., not intended laparoscopic approach).
- Any condition that, in the investigator's opinion, makes participation unsafe or not feasible.
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 |
|---|---|---|
| ICGEmergency laparoscopic cholecystectomy performed with intraoperative indocyanine green fluorescence cholangiography to enhance visualization of the biliary anatomy. | Other | INTERVENTION |
Primary outcome
Incidence of Clinically Relevant Biliary Complications
Time frame: Within 90 days after surgery
Clinically relevant biliary complications defined as bile duct injury or clinically significant bile leak requiring therapeutic intervention. Bile leak will be defined according to the criteria of the International Study Group of Liver Surgery (ISGLS), and bile duct injury will be classified according to the Strasberg classification.
7 secondary outcomes
Overall Postoperative Complications
Time frame: Within 90 days after surgery
Conversion to Open Surgery
Time frame: Day of the Surgery
Length of Hospital Stay
Time frame: Day 1 of admission
Readmission Rate
Time frame: Within 90 days after surgery
Quality of Biliary Anatomy Visualization (ICG group)
Time frame: Day of the Surgery
Surgeon-Reported Surgical Confidence
Time frame: Day of the Surgery
Patient-Reported Outcomes (PROMs)
Time frame: 30 days and 90 days after surgery
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 19 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in publications from this study (after de-identification), including the study protocol, statistical analysis plan, and analytic code, may be shared with qualified researchers upon reasonable request. Requests will be reviewed by the principal investigator and the study steering committee to ensure that the proposed use is scientifically valid and ethically appropriate. Data will be made available after publication of the primary results and will require a data sharing agreement.
Related trials for Acute Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
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.
Ana Maria Gonzalez Castillo, ACBC Trial Ppal Investigator 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 ICG in people with Acute Cholecystitis and Biliary Complications, run by Hospital del Mar 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Mar 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 Ana Maria Gonzalez Castillo, ACBC Trial Ppal Investigator (+34665126866, amgonzalezcastillo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Relevant Biliary Complications (time frame: Within 90 days after surgery). 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 19 Mar 2026.