Acute Cholecystitis Biliary Complications - ICG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICG.
- Who it may be relevant to
- Registry conditions: Acute Cholecystitis, Biliary Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence to Reduce Biliary Complications in Emergency Cholecystectomy for Acute Cholecystitis
Overview
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.
Interventions
- Other ICG
Emergency laparoscopic cholecystectomy performed with intraoperative indocyanine green fluorescence cholangiography to enhance visualization of the biliary anatomy.
Primary outcome measures
- Incidence of Clinically Relevant Biliary Complications [Time frame: Within 90 days after surgery]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Ana Maria Gonzalez Castillo — Cerdanyola del Vallès
Identifiers
NCT: NCT07481760 · ACBC TRIAL