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

Qualifiers

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

Treatments tested in this trial

  • ICG

Treatment groups

296 Participants
are divided into 2 treatment groups

Sponsors and collaborators