Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial
Background One of the most severe complications in laparoscopic cholecystectomy (LC) is intraoperative bile duct injury (BDI). Despite its low incidence, the medical implications for the patient can be serious. Besides, BDI can also generate significant legal issues in healthcare. Different techniqu...
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BMJ Publishing Group
2023-03-01
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| Series: | BMJ Open |
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| author | Patricia Rodríguez-Fortúnez Luis Muñoz-Bellvís Jaime López-Sánchez Sonsoles Garrosa-Muñoz Fernando Pardo Aranda Clara Gené Škrabec Ricardo López Pérez José Manuel Sánchez Santos María del Carmen Esteban Velasco José Quiñones Sampedro Luis Miguel González Fernández Manuel José Iglesias Iglesias Jacobo Trébol López Asunción García Plaza Ana Belén Sánchez Casado Juan Ignacio González Muñoz Omar Abdel-Lah Fernández Manel Cremades Pérez Francisco Espín Álvarez Jordi Navinés López Alba Zárate Pinedo Laura Vidal Piñeiro Ana Piqueras Hinojo Christian Herrero Vicente Esteban Cugat Andorra |
| author_facet | Patricia Rodríguez-Fortúnez Luis Muñoz-Bellvís Jaime López-Sánchez Sonsoles Garrosa-Muñoz Fernando Pardo Aranda Clara Gené Škrabec Ricardo López Pérez José Manuel Sánchez Santos María del Carmen Esteban Velasco José Quiñones Sampedro Luis Miguel González Fernández Manuel José Iglesias Iglesias Jacobo Trébol López Asunción García Plaza Ana Belén Sánchez Casado Juan Ignacio González Muñoz Omar Abdel-Lah Fernández Manel Cremades Pérez Francisco Espín Álvarez Jordi Navinés López Alba Zárate Pinedo Laura Vidal Piñeiro Ana Piqueras Hinojo Christian Herrero Vicente Esteban Cugat Andorra |
| collection | DOAJ |
| description | Background One of the most severe complications in laparoscopic cholecystectomy (LC) is intraoperative bile duct injury (BDI). Despite its low incidence, the medical implications for the patient can be serious. Besides, BDI can also generate significant legal issues in healthcare. Different techniques have been described to reduce the incidence of this complication, and near-infrared fluorescence cholangiography with indocyanine green (NIRFC-ICG) is one of the latest additions. In spite of the great interest aroused by this procedure, there are currently great disparities in the usage or administration protocols of ICG.Methods and analysis This is a randomised, multicentre, per-protocol analysis, open clinical trial with four arms. The estimated duration of the trial is 12 months. The aim of the study is to analyse whether there are differences between the dose and administration ICG intervals to obtain good-quality NIRFC during LC. The primary outcome is the degree of identification of critical biliary structures during LC. In addition, different factors will be analysed that may have an influence on the results of this technique.Ethics and dissemination The trial will be conducted according to the recommendations for Clinical Trials in the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects and the recommendations of the Spanish Agency of Medicines and Medical Devices (AEMPs) for clinical trials. This trial was approved by the local institutional Ethics Committee and the AEMPs. The results of the study will be presented to the scientific community through publications, conferences or other means.EudraCT number 2022-000904-36.Protocol version V.1.4, 2 June 2022Trial registration number NCT05419947. |
| first_indexed | 2024-03-12T15:14:51Z |
| format | Article |
| id | doaj.art-3f111133874a491780eee52463558168 |
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| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:14:51Z |
| publishDate | 2023-03-01 |
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| series | BMJ Open |
| spelling | doaj.art-3f111133874a491780eee524635581682023-08-11T14:05:07ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-067794Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial Patricia Rodríguez-Fortúnez0Luis Muñoz-Bellvís1Jaime López-Sánchez2Sonsoles Garrosa-Muñoz3Fernando Pardo Aranda4Clara Gené Škrabec5Ricardo López Pérez6José Manuel Sánchez Santos7María del Carmen Esteban VelascoJosé Quiñones SampedroLuis Miguel González Fernández8Manuel José Iglesias Iglesias9Jacobo Trébol López10Asunción García Plaza11Ana Belén Sánchez Casado12Juan Ignacio González Muñoz13Omar Abdel-Lah Fernández14Manel Cremades PérezFrancisco Espín Álvarez15Jordi Navinés López16Alba Zárate Pinedo17Laura Vidal Piñeiro18Ana Piqueras Hinojo19Christian Herrero Vicente20Esteban Cugat Andorra21Clinical Trials Unit. Pharmacology department, Hospital Universitario de Canarias, La Laguna, SpainDepartment of General and Gastrointestinal Surgery, Hospital Universitario de Salamanca, Salamanca, SpainDepartment of General and Gastrointestinal Surgery, Hospital Universitario de Salamanca, Salamanca, SpainDepartment of General and Gastrointestinal Surgery, Hospital Universitario de Salamanca, Salamanca, SpainDepartment of General and Gastrointestinal Surgery, Hospital Universitari Germans Trias i Pujol, Badalona, SpainDepartment of General and Gastrointestinal Surgery, Hospital Universitari Germans Trias i Pujol, Badalona, SpainUICEC-Biomedical Research Institute of Salamanca (IBSAL), Universidad de Salamanca, Salamanca, SpainDepartment of Statistics, Hospital Universitario de Salamanca, Salamanca, SpainDr.Dr.Dr.Dra.Dra.Dr.Dr.Dr.Dr.Dra.Dra.Dra.Dr.Dr.Background One of the most severe complications in laparoscopic cholecystectomy (LC) is intraoperative bile duct injury (BDI). Despite its low incidence, the medical implications for the patient can be serious. Besides, BDI can also generate significant legal issues in healthcare. Different techniques have been described to reduce the incidence of this complication, and near-infrared fluorescence cholangiography with indocyanine green (NIRFC-ICG) is one of the latest additions. In spite of the great interest aroused by this procedure, there are currently great disparities in the usage or administration protocols of ICG.Methods and analysis This is a randomised, multicentre, per-protocol analysis, open clinical trial with four arms. The estimated duration of the trial is 12 months. The aim of the study is to analyse whether there are differences between the dose and administration ICG intervals to obtain good-quality NIRFC during LC. The primary outcome is the degree of identification of critical biliary structures during LC. In addition, different factors will be analysed that may have an influence on the results of this technique.Ethics and dissemination The trial will be conducted according to the recommendations for Clinical Trials in the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects and the recommendations of the Spanish Agency of Medicines and Medical Devices (AEMPs) for clinical trials. This trial was approved by the local institutional Ethics Committee and the AEMPs. The results of the study will be presented to the scientific community through publications, conferences or other means.EudraCT number 2022-000904-36.Protocol version V.1.4, 2 June 2022Trial registration number NCT05419947.https://bmjopen.bmj.com/content/13/3/e067794.full |
| spellingShingle | Patricia Rodríguez-Fortúnez Luis Muñoz-Bellvís Jaime López-Sánchez Sonsoles Garrosa-Muñoz Fernando Pardo Aranda Clara Gené Škrabec Ricardo López Pérez José Manuel Sánchez Santos María del Carmen Esteban Velasco José Quiñones Sampedro Luis Miguel González Fernández Manuel José Iglesias Iglesias Jacobo Trébol López Asunción García Plaza Ana Belén Sánchez Casado Juan Ignacio González Muñoz Omar Abdel-Lah Fernández Manel Cremades Pérez Francisco Espín Álvarez Jordi Navinés López Alba Zárate Pinedo Laura Vidal Piñeiro Ana Piqueras Hinojo Christian Herrero Vicente Esteban Cugat Andorra Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial BMJ Open |
| title | Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial |
| title_full | Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial |
| title_fullStr | Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial |
| title_full_unstemmed | Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial |
| title_short | Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial |
| title_sort | dose and administration time of indocyanine green in near infrared fluorescence cholangiography during laparoscopic cholecystectomy dotig study protocol for a randomised clinical trial |
| url | https://bmjopen.bmj.com/content/13/3/e067794.full |
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