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45 results for “cholangiography”
Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG) Dataset.
<p><strong><span>Introduction </span></strong></p> <p><span>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.</span></p> <p><strong><span>Methods</span></strong></p> <p><span>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. </span><span>This trial was approved by the local institutional Ethics Committee</span><span>.</span></p> <p><strong><span>Results </span></strong></p> <p><span>From June 2022 to June 2023, 200 patients were randomised in the four arms (G1: </span><span>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)</span><span>. We found differences in the DISTURBED score between the groups (<em>p</em><0.001), suggesting that ICG administration 15-30 minutes before surgery was worse than administration >3 hours after LC (<em>p</em>=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. </span></p> <p><strong><span>Conclusion </span></strong></p> <p><span>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.</span></p> <p><strong><span>Documentation in ZENODO</span></strong></p> <p>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".</p> <p>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.</p> <p>The data management throughout the study is documented in the document DOTIG_PGD_Data Management Report.</p>
Fluorescent Cholangiography vs White Light for Bile Ducts Identification
ClinicalTrials.gov study NCT02702843. IPD Sharing: YES. Countries: 5. Publications: 1.
Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy
ClinicalTrials.gov study NCT00806780. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP
ClinicalTrials.gov study NCT02611453. IPD Sharing: NO. Countries: 1. Publications: 2.
Promising Initial Experience With Intra-operative Fluorescent Cholangiography
ClinicalTrials.gov study NCT02136095. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis
ClinicalTrials.gov study NCT04103762. IPD Sharing: NO. Countries: 1. Publications: 1.
Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis
ClinicalTrials.gov study NCT04059601. IPD Sharing: UNDECIDED. Countries: 1. Publications: 8.
Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"
ClinicalTrials.gov study NCT06115564. IPD Sharing: Not stated. Countries: 1. Publications: 7.
Fluorescent Cholangiography in Acute Cholecystitis
ClinicalTrials.gov study NCT06573021. IPD Sharing: NO. Countries: 1. Publications: 7.
Radiation Exposure in Intraoperative Cholangiography
ClinicalTrials.gov study NCT03817723. IPD Sharing: NO. Countries: 1. Publications: 17.
Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy
ClinicalTrials.gov study NCT04228835. IPD Sharing: NO. Countries: 1. Publications: 3.
Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy
ClinicalTrials.gov study NCT01847612. IPD Sharing: NO. Countries: 1. Publications: 1.
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
ClinicalTrials.gov study NCT01881399. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Success of Intraoperative Cholangiography
ClinicalTrials.gov study NCT04052633. IPD Sharing: NO. Countries: 1. Publications: 7.
Fluorescence Cholangiography During Cholecystectomy - a RCT
ClinicalTrials.gov study NCT02344654. IPD Sharing: Not stated. Countries: 0. Publications: 2.
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
ClinicalTrials.gov study NCT02070640. IPD Sharing: Not stated. Countries: 1. Publications: 0.
NIR Fluorescence Cholangiography With Low Dose of ICG
ClinicalTrials.gov study NCT04005898. IPD Sharing: Not stated. Countries: 0. Publications: 1.
Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage
ClinicalTrials.gov study NCT01686425. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Metabolic Dysfunction-Associated Fatty Liver Disease Impairs Intraoperative Indocyanine Green Fluorescence Cholangiography Quality: Development and Validation of a Predictive Model
ClinicalTrials.gov study NCT07297225. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy
ClinicalTrials.gov study NCT07400237. IPD Sharing: NO. Countries: 1. Publications: 0.
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