Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG) Dataset.

Introduction

Different techniques have been described to reduce the incidence of the intraoperative bile duct injury during laparoscopic cholecystectomy (LC), and Near-Infrared Fluorescence Cholangiography (NIFC) with Indocyanine Green (ICG) is one of the latest additions. Currently, there are great disparities in the usage or administration protocols of ICG.

Methods

The aim of this randomised multicenter clinical trial (RCT) is to analyse whether there are differences between the dose and administration ICG intervals to obtain good-quality NIFC during LC. In addition, different factors were analysed that may have an influence on the results of this technique. This trial was approved by the local institutional Ethics Committee.

Results

From June 2022 to June 2023, 200 patients were randomised in the four arms (G1: 2.5 mg ICG >3 hours prior to surgery, G2: 2.5 mg ICG 15-30 minutes prior to surgery, G3: 0.05 mg/kg ICG >3 hours prior to surgery and G4: 0.05 mg/kg ICG 15-30 minutes prior to surgery). We found differences in the DISTURBED score between the groups (p<0.001), suggesting that ICG administration 15-30 minutes before surgery was worse than administration >3 hours after LC (p=0.02). We also observed that body mass index, gender, ASA Classification System, previous liver and biliary disease and the type of surgery had influence on NIFC. Finally, the NIFC had impact in intraoperative and postoperative complications, operative time and hospital length of stay.

Conclusion

The time of ICG administration was related to NIFC results, as well as different preoperative predictors. NIFC may also influence in surgical outcomes of LC.

Documentation in ZENODO

Files stored in this repository correspond to the data extracted from the CRDe RedCAP used in this study. The file 'DOTIG_DATA_NoAA_LABELS_2023-10-31' corresponds to the data collected during the study, and the file 'DOTIG_DATA_AA_LABELS_2023-10-31' corresponds to the adverse events recorded during the study. Additionally, there is one more file which is the recoding of adverse events to "MEDDRA Terms (PT) vs 25.1" and "SOC".

IBSAL uses the REDCap system for database creation. A detailed description of the information to be captured in the database is documented in the "DOTID_PGD_Data Dictionary Codebook" document. The structure of this data in the CRDe is described in the "DOTIG_PGD_Annotated CRDe document". The Annotated CRDe details the names of input objects in the CRDe with the name, format, and type of variables that will be used during the data entry process. The database must capture all the elements included in the "DOTIG_PGD_Variable List" document.

The data management throughout the study is documented in the document DOTIG_PGD_Data Management Report.