Low dose vs. standard dose and administration time in near-infrared fluorescence cholangiography during laparoscopic...

Near-infrared fluorescent cholangiography (NIFC) with indocyanine green (ICG) may optimise the outcomes of laparoscopic cholecystectomy (LC), although a lack of consensus remains regarding the optimal dose and timing of administration. This study will evaluate the efficacy of an immediate reduced dose (0.25 mg) compared with the standard preoperative dose (2.5 mg).

Design: Phase IV, randomised, multicentre, parallel-group (1:1) clinical trial, with modified intention-to-treat analysis (EU CT Number: 2025-533535-33-00). Identifiers: EU CT Number: 2025-533535-33-00. Version 1.1, 4 June 2025. Protocol code: Low-DOTIG.

122 adult patients eligible for LC (elective, early or delayed urgent) who meet the inclusion criteria.

(G1) ICG 2.5 mg administered >3 h before surgery; (G2) ICG 0.25 mg administered 15-30 min before surgery.

Rate of identification of biliary structures before and after dissection, degree of biliary visualisation, usefulness of NIFC, and interference from liver background fluorescence.

Influence of perioperative factors, as well as the impact of NIFC on complications, operative time, and hospital stay.

The study has been approved by the AEMPS and the local Research Ethics Committee (CEIm) and will comply with the Declaration of Helsinki, ICH-GCP, current Spanish regulations, and data protection legislation. Results will be disseminated to the scientific community following ICMJE recommendations.