Clinical Trial for the Optimization of Indocyanine Green Administration in NIRF-C During L.Cholecystectomy.

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.

Timeline

Start

2022-06-20

Primary completion

2023-05-16

Completion

2023-10-24

Publications

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• Background Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.
• Lopez-Sanchez J, Garrosa-Munoz S, Pardo Aranda F, Gene Skrabec C, Lopez Perez R, Rodriguez-Fortunez P, Sanchez Santos JM, Munoz-Bellvis L; DOTIG Collaborative Group. 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. 2023 Mar 3;13(3):e067794. doi: 10.1136/bmjopen-2022-067794.

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