Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.

NCT ID: NCT07195331

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-01-31

Brief Summary

Introduction:

This protocol outlines a randomized phase IV clinical trial designed to compare the efficacy of two different doses of indocyanine green (ICG) used in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy (LC)-the current gold standard treatment for symptomatic cholelithiasis. Despite its effectiveness, LC is still associated with significant risks, particularly bile duct injury (BDI), a severe complication that this study aims to mitigate.

Phase: Phase IV Study design: Multicenter, randomized, open-label, parallel-group clinical trial (modified intention-to-treat).

Objectives:

Primary objective:

• To analyze differences between treatment groups (standard dose 2.5 mg >3h preoperative vs reduced dose 0.25 mg immediate preoperative 15-30 min) during laparoscopic cholecystectomy in:
• Visualization of extrahepatic biliary structures
• Degree of visualization
• Degree of background liver fluorescence interference
• Perceived utility of the technique

Secondary objectives:

• Influence of BMI, biliary pathology type, surgery type, prior inflammation, surgical difficulty, previous instrumentation, and laparoscopic imaging system on results
• Intraoperative and postoperative complication rates
• 30-day mortality
• Impact on operative time and hospital stay
• Correlation between subjective and objective fluorescence assessment (ducts-to-liver fluorescence ratio) Population: Patients ≥18 years indicated for laparoscopic cholecystectomy (elective, early or urgent deferred).

Main inclusion criteria:

• Age ≥18 years
• Signed informed consent
• Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis, gallbladder polyps with surgical indication)

Main exclusion criteria:

• Age <18 years
• Pregnancy or lactation
• Chronic kidney disease (stage >IIIb)
• ICG or iodinated contrast allergy
• Functional thyroid disease
• Emergency non-deferrable surgery
• Open approach
• Suspicion of gallbladder carcinoma
• Inability to understand the study Investigational product: Indocyanine green (ICG), intravenous administration

This multicenter study involves two hospitals in Castilla y León, Spain, and plans to enroll 122 adult patients meeting specific clinical criteria for LC. Participants will be randomized into two treatment arms and will receive ICG accordingly:

• Group 1: 2.5 mg >3h before surgery
• Group 2: 0.25 mg 15-30 min before surgery Fluorescence will be assessed both subjectively by the surgical team and objectively through digital image analysis using specialized software to calculate the bile duct-to-liver fluorescence ratio (RFBH).

Endpoints:

• Rates and degree of biliary structure identification pre- and post-dissection
• Perceived utility of cholangiography
• Liver background fluorescence interference
• Ducts-to-liver fluorescence ratio Duration: 12 months recruitment + 1 month follow-up = total 13 months Countries: Spain Ethics: The study will be conducted in accordance with ICH-GCP, EU Clinical Trials Regulation No 536/2014, and applicable national regulations.

Beyond comparing the diagnostic performance of two dosing strategies, this study seeks to provide evidence supporting a more practical and logistically feasible approach for implementing ICG fluorescence cholangiography in routine surgical practice, without compromising diagnostic accuracy or patient safety.

Conditions

Laparoscopic Cholecystectomy Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2.5 mg >3h before surgery

Group Type: EXPERIMENTAL

Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.

Intervention Type: DRUG

A dilution will be prepared by dissolving 25 mg of ICG in 10 mL of water for injectable solutions, yielding a concentration of 2.5 mg/mL. Once the solution is prepared, 1 mL will be administered directly via a peripheral venous line in the patient's upper limb.

0.25 mg 15-30 min before surgery

Group Type: EXPERIMENTAL

Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.

Intervention Type: DRUG

A dilution will be prepared by dissolving 25 mg of ICG in 25 mL of water for injectable solutions, yielding a concentration of 1 mg/mL. Subsequently, 0.25 mL will be administered as a direct intravenous injection via a peripheral venous line in the patient's upper limb.

Interventions

Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.

A dilution will be prepared by dissolving 25 mg of ICG in 10 mL of water for injectable solutions, yielding a concentration of 2.5 mg/mL. Once the solution is prepared, 1 mL will be administered directly via a peripheral venous line in the patient's upper limb.

Intervention Type: DRUG

Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.

A dilution will be prepared by dissolving 25 mg of ICG in 25 mL of water for injectable solutions, yielding a concentration of 1 mg/mL. Subsequently, 0.25 mL will be administered as a direct intravenous injection via a peripheral venous line in the patient's upper limb.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years.
• Signed informed consent.
• Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).

Exclusion Criteria

• Age <18 years.
• Pregnancy or lactation.
• Chronic kidney disease (stage >IIIb).
• ICG allergy.
• Allergy to other iodinated contrast
• Functional thyroid disease.
• Emergency non-deferrable surgery.
• Open approach.
• Suspicion of gallbladder cancer.
• Inability to understand the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Association of Surgeons (AEC)

OTHER

Sponsor Role: collaborator

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime López, Medical Degree in Surgery

Role: PRINCIPAL_INVESTIGATOR

Centro Asistencial Universitario de Salamanca (CAUSA)

Eva Alonso

Role: PRINCIPAL_INVESTIGATOR

Complejo Asistencial de Zamora.

Locations

Hospital Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Virgen de la Concha

Zamora, Zamora, Spain

Countries

Spain

Central Contacts

Fátima Macho Sánchez-Simón, Project Manager

Role: CONTACT

uicec.admon@ibsal.es

+34923291200 ext. 55145

Esperanza López Franco, PhD

Role: CONTACT

uicec.coordinacion@ibsal.es

+34923291200 ext. 55144

Other Identifiers

2025-522535-33-00

Identifier Type: CTIS

Identifier Source: secondary_id

Low-DOTIG

Identifier Type: -

Identifier Source: org_study_id