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| ID | Type | Description | Link |
|---|---|---|---|
| ET12-066 | Other Identifier | Sponsor Number |
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This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery.
This study will be performed on patient intended to undergo a liver cancer surgery.It will contain three steps, assessing the following items:
Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase,
Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic lesions,
Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding per-hepatectomy.
3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step.
Patients will be followed during 4 weeks after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluobeam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluobeam | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| First step: assess the feasibility and the acceptability of Fluobeam |
| During surgery on day 0 |
| Second step: assess the rate of patients in whom, all of the lesions (superficial/deep) will be detected by means of the Fluobeam medical device in peroperative or in postoperative. | During surgery on day 0 | |
| Third step: assess the rate of patients in whom, among the 7 liver segments, the surgeon will be able to selectively target a predefined area. | During surgery on day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| First step: assess the ability to visualize the fluorescent anatomical areas | During surgery on day 0 | |
| First step: Quantify the fluorescence | by using the images obtained during the surgery | After the surgery, on day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Peyrat | Centre Léon Bérard, LYON, FRANCE. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | 69373 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19844652 | Background | Aoki T, Murakami M, Yasuda D, Shimizu Y, Kusano T, Matsuda K, Niiya T, Kato H, Murai N, Otsuka K, Kusano M, Kato T. Intraoperative fluorescent imaging using indocyanine green for liver mapping and cholangiography. J Hepatobiliary Pancreat Sci. 2010 Sep;17(5):590-4. doi: 10.1007/s00534-009-0197-0. Epub 2009 Oct 21. | |
| 18543027 | Background |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| First step: assess the ability to review saved data | After the surgery, on day 0 |
| Second step: assess the ability to detect tumor lesions which were not previously known. | Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis. | During surgery on day 0 |
| Second step: assess the rate of modifications of the surgical plan. | Number of patients for whom the surgery would be modified after using Fluobeam. | During surgery on day 0 |
| Second step: assess the quality of the resection margins. | It will be measured using the residual fluorescence and the pathology analysis | After the surgery on day 0 |
| Second step: assess the depth limit of detection of the fluorescence. | It will be assessed after the anatomopathological analysis. | After the pathology analysis on day 0 |
| Second step: Quantify the fluorescence. | From images obtained during the surgery and from the sample analysed by a pathologist. | After the surgery, on day 0 |
| Second step: assess the number of asepsis due to Fluobeam | During surgery on day 0 |
| Third step: assess the ability to detect tumor lesions which were not previously known. | Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis | During surgery on day 0 |
| Third step: quantify the fluorescence. | From images obtained during the surgery and from the sample analysed by a pathologist. | After the surgery on day 0 |
| Third step: assess the ability to administer two doses of ICG in the same patient | one before and one during the surgery (tumor detection and segment targeting respectively). | On day 0 |
| Third step: assess the number of asepsis due to Fluobeam | During surgery on day 0 |
| Third step: assess the ability of the medical device to detect tumor lesions which were previously known. | Number of lesions seen on images before and during the surgery and detected by Fluobeam. | On day 0 |
| Aoki T, Yasuda D, Shimizu Y, Odaira M, Niiya T, Kusano T, Mitamura K, Hayashi K, Murai N, Koizumi T, Kato H, Enami Y, Miwa M, Kusano M. Image-guided liver mapping using fluorescence navigation system with indocyanine green for anatomical hepatic resection. World J Surg. 2008 Aug;32(8):1763-7. doi: 10.1007/s00268-008-9620-y. |
| Background | Barbare JC. Quantification de la fonction hépatique: Pourquoi et comment? John Libbey Eurotext. HEPATO-GASTRO.5(6):423-431,1998. |
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| Background | Hamamatsu Photonics-Pulsion Medical System.PDE Photodynamic Eye. http://www.iht-ltd.com/pde-photodynamic-eye/ |
| Background | Hamoui M; Marchand JP. Boutabrine H. Navarro F. L'évaluation préopératoire du risque d'insuffisance hépatocellulaire lors des résections hépatiques sur foie cirrhotique. John Libbey Eurotext.HEPATO-GASTRO. 16(1):11-19, 2009 |
| Background | HAS.Guide ALD30-Tumeur maligne, affection maligne du tissu lymphatique ou hématopoïétique-Cancer primitif du foie. http://www.e-cancer.fr/soins/recommandations/cancers-digestifs |
| Background | HAS. Guide ALD-Tumeur maligne, affection maligne du tissu lymphatique ou hématopoïétique-Cancer colorectal Adénocarcinome. http://www.e-cancer.fr/soins/recommandations/cancers-digestifs |
| 19326450 | Background | Ishizawa T, Fukushima N, Shibahara J, Masuda K, Tamura S, Aoki T, Hasegawa K, Beck Y, Fukayama M, Kokudo N. Real-time identification of liver cancers by using indocyanine green fluorescent imaging. Cancer. 2009 Jun 1;115(11):2491-504. doi: 10.1002/cncr.24291. |
| 22260827 | Background | Ishizuka M, Kubota K, Kita J, Shimoda M, Kato M, Sawada T. Intraoperative observation using a fluorescence imaging instrument during hepatic resection for liver metastasis from colorectal cancer. Hepatogastroenterology. 2012 Jan-Feb;59(113):90-2. doi: 10.5754/hge11223. |
| 11333094 | Background | Jarnagin WR, Bach AM, Winston CB, Hann LE, Heffernan N, Loumeau T, DeMatteo RP, Fong Y, Blumgart LH. What is the yield of intraoperative ultrasonography during partial hepatectomy for malignant disease? J Am Coll Surg. 2001 May;192(5):577-83. doi: 10.1016/s1072-7515(01)00794-3. |
| 22200990 | Background | Morita Y, Sakaguchi T, Unno N, Shibasaki Y, Suzuki A, Fukumoto K, Inaba K, Baba S, Takehara Y, Suzuki S, Konno H. Detection of hepatocellular carcinomas with near-infrared fluorescence imaging using indocyanine green: its usefulness and limitation. Int J Clin Oncol. 2013 Apr;18(2):232-41. doi: 10.1007/s10147-011-0367-3. Epub 2011 Dec 27. |
| Background | O2View. ArteMIS Handheld Complete System. http://o2view.com/ |
| 15849507 | Background | Pawlik TM, Scoggins CR, Zorzi D, Abdalla EK, Andres A, Eng C, Curley SA, Loyer EM, Muratore A, Mentha G, Capussotti L, Vauthey JN. Effect of surgical margin status on survival and site of recurrence after hepatic resection for colorectal metastases. Ann Surg. 2005 May;241(5):715-22, discussion 722-4. doi: 10.1097/01.sla.0000160703.75808.7d. |
| 14769718 | Background | Reuthebuch O, Haussler A, Genoni M, Tavakoli R, Odavic D, Kadner A, Turina M. Novadaq SPY: intraoperative quality assessment in off-pump coronary artery bypass grafting. Chest. 2004 Feb;125(2):418-24. doi: 10.1378/chest.125.2.418. |
| Background | Rivoire M.Diagnostiquer une tumeur du foie primitive et secondaire. http://cancero.unice.fr/sitelocal/disciplines/niveaudiscipline/cancerologie/numlecon151/leconimprim.pdf |
| 21495033 | Background | Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol. 2011 Sep 1;104(3):323-32. doi: 10.1002/jso.21943. Epub 2011 Apr 14. |
| Background | Société Française de Chirurgie Digestive (SFCD), Association de Chirurgie hépatobiliaire et de Transplantation Hépatique (ACHBT). Prise en charge des patients atteints de métastases hépatiques synchrones du cancer colorectal-Recommandations professionnelles-Synthèse. www.e-cancer.fr |
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| 19435621 | Result | Slim K, Blay JY, Brouquet A, Chatelain D, Comy M, Delpero JR, Denet C, Elias D, Flejou JF, Fourquier P, Fuks D, Glehen O, Karoui M, Kohneh-Shahri N, Lesurtel M, Mariette C, Mauvais F, Nicolet J, Perniceni T, Piessen G, Regimbeau JM, Rouanet P, sauvanet A, Schmitt G, Vons C, Lasser P, Belghiti J, Berdah S, Champault G, Chiche L, Chipponi J, Chollet P, De Baere T, Dechelotte P, Garcier JM, Gayet B, Gouillat C, Kianmanesh R, Laurent C, Meyer C, Millat B, Msika S, Nordlinger B, Paraf F, Partensky C, Peschaud F, Pocard M, Sastre B, Scoazec JY, Scotte M, Triboulet JP, Trillaud H, Valleur P. [Digestive oncology: surgical practices]. J Chir (Paris). 2009 May;146 Suppl 2:S11-80. doi: 10.1016/S0021-7697(09)72398-1. No abstract available. French. |
| D008107 |
| Liver Diseases |