Acute Cholecystitis Biliary Complications - ICG
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital del Mar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
ICG
Other interventionEmergency laparoscopic cholecystectomy performed with intraoperative indocyanine green fluorescence cholangiography to enhance visualization of the biliary anatomy.
Treatment groups
296 Participants
are divided into 2 treatment groupsGroup A: CONTROLNo intervention 0 interventions
Group B: INTERVENTIONExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
Conversion to Open Surgery
Rate of conversion from laparoscopic to open cholecystectomy during surgery.
Time frame
Day of the Surgery3
Length of Hospital Stay
Postoperative hospital stay measured in days from surgery to hospital discharge.
Time frame
Day 1 of admission4
Readmission Rate
Unplanned hospital readmission related to the surgical procedure or postoperative complications.
Time frame
Within 90 days after surgerySponsors and contacts
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Source ClinicalTrials.gov
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