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

Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León (Other)
Overall Status
Recruiting
CT.gov ID
NCT05419947
Collaborator
Instituto de Investigación Biomédica de Salamanca (Other)
200
Enrollment
2
Locations
4
Arms
17.4
Anticipated Duration (Months)
100
Patients Per Site
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: VERDYE powder for solution for injection 25 mg
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects included in this CT will be treated with VI [Verdye (Diagnostic Green GMBH, Aschheim-Dornach, Germany)]. Single dose and weight-adjusted dose and different administration intervals will be analyzed. Low-intervention clinical trial.Subjects included in this CT will be treated with VI [Verdye (Diagnostic Green GMBH, Aschheim-Dornach, Germany)]. Single dose and weight-adjusted dose and different administration intervals will be analyzed. Low-intervention clinical trial.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Clinical Trial for the Optimization of Indocyanine Green Administration in Near-infrared Fluorescent Cholangiography During Laparoscopic Cholecystectomy.
Actual Study Start Date :
Jun 20, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Identification of biliary structures prior to dissection of the hepatocystic triangle. [At the time of the surgical procedure]

      Identification of biliary structures prior to dissection of the hepatocystic triangle. "yes" or "no" will be used to determine whether to display: Identification of the cystic duct prior to dissection Identification of the common bile duct prior to dissection Identification of the junction of the cystic duct with the common bile duct prior to dissection Identification of the union of the cystic duct with the gallbladder prior to dissection Identification of the common hepatic duct prior to dissection Identification of biliary anatomical variables prior to dissection 6.1. High implantation cystic duct 6.2. short cystic duct 6.3. Anterior spiral cystic duct, with mouth on the left side of the bile duct 6.4. Posterior spiral cystic duct, with mouth on the left side of the bile duct 6.5. Aberrant right hepatic duct, with drainage into the cystic duct 6.6. Others

    2. Identification of biliary structures after dissection of the hepatocystic triangle. [At the time of the surgical procedure]

      Identification of biliary structures after dissection of the hepatocystic triangle. "yes" or "no" will be used to determine whether to display: Identification of the cystic duct prior to dissection Identification of the common bile duct prior to dissection Identification of the junction of the cystic duct with the common bile duct prior to dissection Identification of the union of the cystic duct with the gallbladder prior to dissection Identification of the common hepatic duct prior to dissection Identification of biliary anatomical variables prior to dissection 6.1. High implantation cystic duct 6.2. short cystic duct 6.3. Anterior spiral cystic duct, with mouth on the left side of the bile duct 6.4. Posterior spiral cystic duct, with mouth on the left side of the bile duct 6.5. Aberrant right hepatic duct, with drainage into the cystic duct 6.6. Others

    Secondary Outcome Measures

    1. Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. [At the time of the surgical procedure]

      Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent

    2. Degree of identification of biliary structures after dissection of the hepatocystic triangle. [At the time of the surgical procedure]

      Degree of identification of biliary structures after dissection of the hepatocystic triangle. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent

    3. Extent to which fluorescence cholangiography was perceived as useful for surgery [At the time of the surgical procedure]

      Extent to which fluorescence cholangiography was perceived as useful for surgery The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful

    4. Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. [At the time of the surgical procedure]

      Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Germans Trias i Pujol. Badalona Barcelona Spain 08916
    2 Complejo Asistencial Universitario de Salamanca Salamanca Spain 37007

    Sponsors and Collaborators

    • Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
    • Instituto de Investigación Biomédica de Salamanca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
    ClinicalTrials.gov Identifier:
    NCT05419947
    Other Study ID Numbers:
    • IBS-DOTIG-ECM-2202
    • 2022-000904-36
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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

    Study Results

    No Results Posted as of Jul 7, 2022