An interventional study of ICG in Acute Cholecystitis and Biliary Complications, sponsored by Hospital del Mar. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Hospital del Mar · Not applicable, Interventional, and Treatment
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.
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.
150 studies on the registry are indexed under Cholecystitis, Acute; 36 are open to participants now.
This study's planned enrollment of 296 is above the median of 90 across 89 interventional studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Hospital del Mar is the lead sponsor of 45 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
STANDARD CHOLECYSTECTOMY: laparoscopic cholecystectomy without the use of any contrast, just pure surgical anatomy.
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.
Other: ICG
Emergency laparoscopic cholecystectomy performed with intraoperative indocyanine green fluorescence cholangiography to enhance visualization of the biliary anatomy.
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.
Time frame: Within 90 days after surgery
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).
Time frame: Within 90 days after surgery
Conversion to Open Surgery
Rate of conversion from laparoscopic to open cholecystectomy during surgery.
Time frame: Day of the Surgery
Length of Hospital Stay
Postoperative hospital stay measured in days from surgery to hospital discharge.
Time frame: Day 1 of admission
Readmission Rate
Unplanned hospital readmission related to the surgical procedure or postoperative complications.
Time frame: 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.
Time frame: Day of the Surgery
Surgeon-Reported Surgical Confidence
Surgeon-reported perception of anatomical clarity and confidence during dissection, measured using a structured postoperative questionnaire.
Time frame: Day of the Surgery
Patient-Reported Outcomes (PROMs)
Patient-reported health status assessed using the EQ-5D-5L questionnaire.
Time frame: 30 days and 90 days after surgery
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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