Clinical Trial for the Optimization of Indocyanine Green Administration in NIRF-C During L.Cholecystectomy. (DOTIG)

June 2, 2025 updated by: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Randomized Clinical Trial for the Optimization of Indocyanine Green Administration in Near-infrared Fluorescent Cholangiography During Laparoscopic Cholecystectomy.

Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure.

Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • Complejo Asistencial Universitario de Salamanca
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age over 18 years.
  • Autonomy, self-sufficiency and independence.
  • Scheduled CL indication:
  • Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis.
  • Gallbladder polyps with indication for laparoscopic surgery.
  • Vesicular adenomyomatosis with indication for laparoscopic surgery.
  • Indication of early LC (<72 hours of admission for acute stone cholecystitis/acute acalculous cholecystitis/complicated biliary colic).
  • Deferred urgency LC indication.
  • Understanding of information.
  • Signature of the informed consent.

Exclusion Criteria:

  • Age less than 18 years.
  • Disability.
  • Pregnancy or lactation.
  • Chronic kidney disease (Stage > IIIb).
  • Previous adverse reactions or allergies to VI.
  • Previous adverse reactions or allergies to VI excipients.
  • Adverse reactions or confirmed allergies to iodinated contrast agents.
  • Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
  • Urgent non-deferrable/emergent gallbladder surgery.
  • Initial surgery by laparotomy.
  • Previous suspicion of gallbladder carcinoma.
  • Inability to understand the information needed to participate in the study.
  • Rejection of inclusion within the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixed dose 3 hours
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
Drug: VERDYE powder for solution for injection 25 mg
Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
Other Names:
  • Indocyanine green (ICG)
Experimental: Fixed dose 30 min
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
Drug: VERDYE powder for solution for injection 25 mg
Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
Other Names:
  • Indocyanine green (ICG)
Experimental: Weight-adjusted dose 3 hour
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
Drug: VERDYE powder for solution for injection 25 mg
Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
Other Names:
  • Indocyanine green (ICG)
Experimental: Weight-adjusted dose 30 min
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
Drug: VERDYE powder for solution for injection 25 mg
Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
Other Names:
  • Indocyanine green (ICG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Time Frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.

Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun.

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
During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Time Frame: During surgical procedure, after dissection of the hepatocystic triangle.

Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun.

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
During surgical procedure, after dissection of the hepatocystic triangle.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Time Frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.

Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun.

The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Time Frame: During surgical procedure, after the disection of the hepatocystic triangle has begun.

Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun.

The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
During surgical procedure, after the disection of the hepatocystic triangle has begun.
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
Time Frame: During surgical procedure

Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun.

The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
During surgical procedure
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Time Frame: During surgical procedure

Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun.

The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
During surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Collaborators

Instituto de Investigación Biomédica de Salamanca

Investigators

  • Principal Investigator: Jaime López Sánchez, MD, University of Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Actual)

May 16, 2023

Study Completion (Actual)

October 24, 2023

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IBS-DOTIG-ECM-2202
  • 2022-000904-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

From the date of publication of the results.

IPD Sharing Access Criteria

Through access to the journal where the results are published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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