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

NCT05419947 | Completed Phase 4 Results

• 2 other identifiers: IBS-DOTIG-ECM-22022022-000904-36
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Identification of Biliary Structures Prior to 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.

  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 Outcomes (4)

• Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.

  During surgical procedure, before beginning the dissection of the hepatocystic triangle.

• Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.

  During surgical procedure, after the disection of the hepatocystic triangle has begun.

• Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery

  During surgical procedure

• Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.

  During surgical procedure

Study Arms (4)

Fixed dose 3 hours

EXPERIMENTAL

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

Fixed dose 30 min

EXPERIMENTAL

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

Weight-adjusted dose 3 hour

EXPERIMENTAL

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

Weight-adjusted dose 30 min

EXPERIMENTAL

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

Interventions

VERDYE powder for solution for injection 25 mg DRUG

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.

Also known as: Indocyanine green (ICG)

Fixed dose 3 hours; Fixed dose 30 min; Weight-adjusted dose 3 hour; Weight-adjusted dose 30 min

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Hospital Universitario Germans Trias i Pujol.

Badalona, Barcelona, 08916, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

Related Publications (20)

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MeSH Terms

Interventions

Solutions; Injections; Indocyanine Green

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Luis Muñoz Bellvís
• Organization: Instituto de Investigación Biomédica de Salamanca (IBSAL)

luismb@usal.es

0034 923 29 11 00

Study Officials

• Jaime López Sánchez, MD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 15, 2022
• Study Start: June 20, 2022
• Primary Completion: May 16, 2023
• Study Completion: October 24, 2023
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From the date of publication of the results.
• Access Criteria: Through access to the journal where the results are published.

Locations

ES (2)