Laparoscopic Cholecystectomy SurgeryPhase 4NCT07195331
Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.
A Phase 4 study testing Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject. and Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject. in people with Laparoscopic Cholecystectomy Surgery, run by Instituto de Investigación Biomédica de Salamanca at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery
- What is being tested?
- Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject. and Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesSpain
- Study dates
- 26 Feb 2026to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Signed informed consent.
- Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).
Who cannot join
- Age <18 years.
- Pregnancy or lactation.
- Chronic kidney disease (stage >IIIb).
- ICG allergy.
- Allergy to other iodinated contrast
- Functional thyroid disease.
Show all 10Show fewer
- Emergency non-deferrable surgery.
- Open approach.
- Suspicion of gallbladder cancer.
- Inability to understand the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37006
- Not yet recruiting
Hospital Virgen de la Concha
Zamora, Zamora, 49022
About this study
Official title: Reduced Dose vs Standard Dose of Indocyanine Green in Near-infrared Fluorescence Cholangiography During Laparoscopic Cholecystectomy: a Randomized Clinical Trial.
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.
Read more
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
- Being tested
- Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject., Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.
- Keywords
- laparoscopic cholecystectomy, bile ducts, cholangiography, indocyanine green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.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.
Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.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.
| Study group | Role | What they receive |
|---|---|---|
| 2.5 mg >3h before surgery | Experimental | Not described Receives: Drug: Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject. |
| 0.25 mg 15-30 min before surgery | Experimental | Not described Receives: Drug: Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of biliary structures prior to dissection of the hepatocystic triangle.
The identification of extrahepatic biliary structures prior to the dissection of the hepatocystic triangle is defined as the visualization of fluorescence emitted by these structures during laparoscopic surgery, at a minimum distance of 15 cm from the anatomical structure and with a perpendicular orientation of the laparoscopic optics to it. The following scale will be used: Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection.
Measured: During surgery
Identification rate of biliary structures after dissection of the hepatocystic triangle
The identification of extrahepatic biliary structures after dissection of the hepatocystic triangle is defined as the visualization of fluorescence emitted by these structures during laparoscopic surgery, at a minimum distance of 15 cm from the anatomical structure and with a perpendicular orientation of the laparoscopic optics over it. The following scale will be used: Category 1. Identification of the cystic duct after the dissection Category 2. Identification of the common bile duct after the dissection. Category 3. Identification of the junction of the cystic duct with the common bile duct after the dissection Category 4. Identification of the union of the cystic duct with the gallbladder after the dissection Category 5. Identification of the common hepatic duct after the dissection Category 6. Identification of biliary anatomical variables after the dissection.
Measured: During surgery.
Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle
The degree of identification of extrahepatic biliary structures is assessed using a 3-point Likert scale:
Poor (1): unable to distinguish fluorescence in extrahepatic biliary structures.
Good (2): able to visualize fluorescence at least in the main bile duct. Excellent (3): able to visualize fluorescence in the main bile duct, the cystic duct, and their junction.
The assessment of this variable must be performed before any surgical maneuver within the hepatocystic triangle.
Measured: During surgery
Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle
The degree of identification of extrahepatic biliary structures is assessed using a 3-point Likert scale:
Poor (1): unable to distinguish fluorescence in extrahepatic biliary structures.
Good (2): able to visualize fluorescence at least in the main bile duct. Excellent (3): able to visualize fluorescence in the main bile duct, the cystic duct, and their junction.
The assessment of this variable must be performed before any surgical maneuver within the hepatocystic triangle.
Measured: During surgery.
Perceived usefulness of fluorescence cholangiography (FC).
The usefulness of FC during surgery is assessed using a 3-point Likert scale:
Not useful (1): the technique did not provide any benefit or even hindered the procedure.
Moderately useful (2): the technique guided certain phases of the procedure. Very useful (3): the technique guided most phases of the procedure, assisted decision-making, or even modified a previous surgical decision.
Measured: During surgery
Degree to which background liver fluorescence (contrast between the liver and biliary ducts) was perceived as disturbing
The disturbing effect of background liver fluorescence is assessed using a 3-point Likert scale:
None (0): liver fluorescence was almost imperceptible and/or allowed clear visualization of hepatocystic triangle structures before dissection.
Slightly disturbing (1): liver fluorescence was evident but still allowed clear visualization of hepatocystic triangle structures after dissection.
Very disturbing (2): liver fluorescence was significantly disturbing and prevented identification of extrahepatic biliary anatomy either before or after dissection of the hepatocystic triangle.
Measured: During surgery
Secondary outcomes (4)
To analyze the rate of postoperative complications related to FC during LC.
The evaluation will be focused on identifying and quantifying adverse events potentially attributable to the use of fluorescence cholangiography (FC) during laparoscopic cholecystectomy (LC). Complications of interest will include, but will not be limited to, allergic reactions to indocyanine green, bile duct injury, postoperative bile leak, surgical site infection, or any other event directly associated with the intraoperative use of FC. The rate of these complications will be recorded and analyzed to assess the safety profile of FC as an adjunct to LC.
Measured: From surgery to 30 days post-surgery
To analyze hospital and 30-day mortality rates.
Hospital and 30-day mortality rates will be assessed as key safety outcomes. Mortality is defined as any death occurring during the index hospital admission or within 30 days after laparoscopic cholecystectomy, regardless of cause. Both in-hospital and 30-day mortality will be systematically recorded to provide a comprehensive evaluation of short-term survival and to ensure patient safety in the context of fluorescence cholangiography use.
Measured: From surgery to 30 days post-surgery
To analyze the impact of the technique on operative time, intraoperative/postoperative complications, and hospital stay.
The impact of the technique on operative time, intraoperative and postoperative complications, and length of hospital stay will be analyzed. Operative time will be measured from the initial skin incision to wound closure. Intraoperative and postoperative complications will be prospectively recorded and categorized according to standardized surgical criteria. Length of hospital stay will be calculated in days from surgery until discharge. This analysis will allow evaluation of the overall clinical impact of the technique on surgical efficiency, patient outcomes, and resource utilization.
Measured: From surgery to 30 days post-surgery.
To analyze the correlation between the subjective and objective assessment of the procedure through the use of the bile duct-to-liver fluorescence ratio.
In this trial, in addition to the subjective assessment of fluorescence, an objective evaluation will be introduced as a novel approach, with the aim of establishing a correlation between the two. For this purpose, the biliary duct-to-liver fluorescence ratio (BDHR) will be calculated by determining the average intensity in the biliary ducts and the average intensity in the hepatic tissue given by the fluorescense detected in the images taken during the procedure: BDHR=Intensity biliary duct/Intensity liver.
The results will be interpreted as follows:
BDHR = 1: Biliary duct fluorescence similar to hepatic parenchyma.
BDHR > 1: Biliary duct fluorescence greater than hepatic parenchyma → Adequate visualization.
BDHR < 1: Biliary duct fluorescence lower than hepatic parenchyma → Inadequate visualization.
Measured: During surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start26 Feb 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC)
- Responsible party
- Sponsor
- Investigators
- Jaime López, Medical Degree in Surgery, Principal investigator, Centro Asistencial Universitario de Salamanca (CAUSA)Eva Alonso, Principal investigator, Complejo Asistencial de Zamora.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195331
- Sponsor's protocol ID
- Low-DOTIG
- Other IDs
- 2025-522535-33-00, 2025
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Dose vs Standard Dose of Indocyanine Green in Near-infrared Fluorescence Cholangiography During Laparoscopic Cholecystectomy: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07195331
- Acronym / sponsor ID
- Low-DOTIG
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Keywords
- laparoscopic cholecystectomy, bile ducts, cholangiography, indocyanine green
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Instituto de Investigación Biomédica de SalamancaUniversity, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5 mg >3h before surgery | Experimental | Drug: Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject. |
| 0.25 mg 15-30 min before surgery | Experimental | Drug: Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Signed informed consent.
- Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).
Key exclusion criteria (10 listed)
- Age <18 years.
- Pregnancy or lactation.
- Chronic kidney disease (stage >IIIb).
- ICG allergy.
- Allergy to other iodinated contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | 2.5 mg >3h before surgery |
| 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. | Drug | 0.25 mg 15-30 min before surgery |
Primary outcome
Identification of biliary structures prior to dissection of the hepatocystic triangle.
Time frame: During surgery
The identification of extrahepatic biliary structures prior to the dissection of the hepatocystic triangle is defined as the visualization of fluorescence emitted by these structures during laparoscopic surgery, at a minimum distance of 15 cm from the anatomical structure and with a perpendicular orientation of the laparoscopic optics to it. The following scale will be used: Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection.
Identification rate of biliary structures after dissection of the hepatocystic triangle
Time frame: During surgery.
The identification of extrahepatic biliary structures after dissection of the hepatocystic triangle is defined as the visualization of fluorescence emitted by these structures during laparoscopic surgery, at a minimum distance of 15 cm from the anatomical structure and with a perpendicular orientation of the laparoscopic optics over it. The following scale will be used: Category 1. Identification of the cystic duct after the dissection Category 2. Identification of the common bile duct after the dissection. Category 3. Identification of the junction of the cystic duct with the common bile duct after the dissection Category 4. Identification of the union of the cystic duct with the gallbladder after the dissection Category 5. Identification of the common hepatic duct after the dissection Category 6. Identification of biliary anatomical variables after the dissection.
Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle
Time frame: During surgery
The degree of identification of extrahepatic biliary structures is assessed using a 3-point Likert scale: Poor (1): unable to distinguish fluorescence in extrahepatic biliary structures. Good (2): able to visualize fluorescence at least in the main bile duct. Excellent (3): able to visualize fluorescence in the main bile duct, the cystic duct, and their junction. The assessment of this variable must be performed before any surgical maneuver within the hepatocystic triangle.
Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle
Time frame: During surgery.
The degree of identification of extrahepatic biliary structures is assessed using a 3-point Likert scale: Poor (1): unable to distinguish fluorescence in extrahepatic biliary structures. Good (2): able to visualize fluorescence at least in the main bile duct. Excellent (3): able to visualize fluorescence in the main bile duct, the cystic duct, and their junction. The assessment of this variable must be performed before any surgical maneuver within the hepatocystic triangle.
Perceived usefulness of fluorescence cholangiography (FC).
Time frame: During surgery
The usefulness of FC during surgery is assessed using a 3-point Likert scale: Not useful (1): the technique did not provide any benefit or even hindered the procedure. Moderately useful (2): the technique guided certain phases of the procedure. Very useful (3): the technique guided most phases of the procedure, assisted decision-making, or even modified a previous surgical decision.
Degree to which background liver fluorescence (contrast between the liver and biliary ducts) was perceived as disturbing
Time frame: During surgery
The disturbing effect of background liver fluorescence is assessed using a 3-point Likert scale: None (0): liver fluorescence was almost imperceptible and/or allowed clear visualization of hepatocystic triangle structures before dissection. Slightly disturbing (1): liver fluorescence was evident but still allowed clear visualization of hepatocystic triangle structures after dissection. Very disturbing (2): liver fluorescence was significantly disturbing and prevented identification of extrahepatic biliary anatomy either before or after dissection of the hepatocystic triangle.
4 secondary outcomes
To analyze the rate of postoperative complications related to FC during LC.
Time frame: From surgery to 30 days post-surgery
To analyze hospital and 30-day mortality rates.
Time frame: From surgery to 30 days post-surgery
To analyze the impact of the technique on operative time, intraoperative/postoperative complications, and hospital stay.
Time frame: From surgery to 30 days post-surgery.
To analyze the correlation between the subjective and objective assessment of the procedure through the use of the bile duct-to-liver fluorescence ratio.
Time frame: During surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaime López, Medical Degree in Surgery principal investigator
Centro Asistencial Universitario de Salamanca (CAUSA)
Eva Alonso principal investigator
Complejo Asistencial de Zamora.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject. and Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject. in people with Laparoscopic Cholecystectomy Surgery, run by Instituto de Investigación Biomédica de Salamanca at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fátima Macho Sánchez-Simón, Project Manager (+34923291200 ext. 55145, uicec.admon@ibsal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of biliary structures prior to dissection of the hepatocystic triangle. (time frame: During surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.