Acute Cholecystitis Biliary Complications - ICG

NCT07481760 | Not Yet Recruiting DMC

• 1 other identifier: ACBC TRIAL
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

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.

  Within 90 days after surgery

Secondary Outcomes (7)

• Overall Postoperative Complications

  Within 90 days after surgery

• Conversion to Open Surgery

  Day of the Surgery

• Length of Hospital Stay

  Day 1 of admission

• Readmission Rate

  Within 90 days after surgery

• Quality of Biliary Anatomy Visualization (ICG group)

  Day of the Surgery

Study Arms (2)

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.

Other: ICG

Interventions

ICG OTHER

Emergency laparoscopic cholecystectomy performed with intraoperative indocyanine green fluorescence cholangiography to enhance visualization of the biliary anatomy.

INTERVENTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Ana Maria Gonzalez Castillo

Cerdanyola del Vallès, Barcelona, 08290, Spain

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Ana Maria Gonzalez Castillo, ACBC Trial Ppal Investigator

CONTACT

+34665126866; amgonzalezcastillo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the surgical intervention, the operating surgeon cannot be blinded to treatment allocation. However, postoperative complications will be assessed by independent outcome adjudicators blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 19, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)