Phase 4
Completed N=200
Clinical Trial for the Optimization of Indocyanine Green Administration in NIRF-C During L.Cholecystectomy.
Source: ClinicalTrials.gov NCT05419947 ↗Enrolled (actual)
200
Serious AEs
6.6%
Results posted
Jun 2025
Primary outcomePrimary: Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. — 26; 20; 26; 29 Participants
◆ Published Evidence
Emerging
14citations · ~5 / year
Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial.
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.
Linked Publications
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Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. |
26; 20; 26; 29; 32; 25 | — |
| PRIMARY Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. |
40; 38; 36; 45; 42; 33 | — |
| SECONDARY Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. |
12; 20; 12; 25; 11; 7 | — |
| SECONDARY Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. |
6; 6; 5; 13; 6; 12 | — |
| SECONDARY Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery |
4; 9; 3; 13; 22; 24 | — |
| SECONDARY Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. |
26; 12; 26; 7; 16; 17 | — |
Eligibility Criteria
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT05419947) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.