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Techniques of Fluorescence Cholangiography During Medicine® OBSERVATIONAL STUDY Techniques of Fluorescence Cholangiography During Laparoscopic Cholecystectomy for Better Delineation of the Bile Duct Anatomy Yoshiharu Kono, MD, Takeaki Ishizawa, MD, PhD, FACS, Keigo Tani, MD, Nobuhiro Harada, MD, Junichi Kaneko, MD, PhD, Akio Saiura, MD, PhD, Yasutsugu Bandai, MD, PhD, and Norihiro Kokudo, MD, PhD, FACS Abstract: To evaluate the clinical and technical factors affecting the possible before surgery, sufficient extension of connective tissues ability of fluorescence cholangiography (FC) using indocyanine green around the bile ducts, and placement of the tip of laparoscope close (ICG) to delineate the bile duct anatomy during laparoscopic chole- and vertically to Calot’s triangle. cystectomy (LC). (Medicine 94(25):e1005) Application of FC during LC began after laparoscopic fluorescence imaging systems became commercially available. Abbreviations: FC = fluorescence cholangiography, ICG = In 108 patients undergoing LC, FC was performed by preoperative indocyanine green, LC = Laparoscopic cholecystectomy, CyD = intravenous injection of ICG (2.5 mg) during dissection of Calot’s cystic duct, CHD = common hepatic duct, BMI = body mass index, triangle, and clinical factors affecting the ability of FC to delineate LS = laparoscopic fluorescence system, OS = fluorescence imaging the extrahepatic bile ducts were evaluated. Equipment-related factors system for open surgery, FI = fluorescence intensity. associated with bile duct detectability were also assessed among 5 laparoscopic systems and 1 open fluorescence imaging system in ex vivo studies. FC delineated the confluence between the cystic duct and common INTRODUCTION ince radiographic intraoperative cholangiography (IOC) hepatic duct (CyD–CHD) before and after dissection of Calot’s triangle 1 in 80 patients (74%) and 99 patients (92%), respectively. The interval S was first reported in 1931, this procedure has been widely between ICG injection and FC before dissection of Calot’s triangle was used as almost the only method by which to delineate the bile significantly longer in the 80 patients in whom the CyD–CHD con- duct anatomy during cholecystectomy. Several studies have fluence was detected by fluorescence imaging before dissection revealed that routine use of IOC during laparoscopic cholecys- tectomy (LC) may reduce the incidence of bile duct injury,2,3 or (median, 90 min; range, 15–165 min) than in the remaining 28 patients 4,5 in whom the confluence was undetectable (median, 47 min; range, 21– at least its severity. In practice, however, the frequency of use 205 min; P < 0.01). The signal contrast on the fluorescence images of of IOC during LC varies widely among surgeons and hospitals, the bile duct samples was significantly different among the laparoscopic probably because of several disadvantages of IOC: a longer imaging systems and tended to decrease more steeply than those of the operation time, the need for additional medical resources, open imaging system as the target-laparoscope distance increased and exposure of the patient and medical staff to radiation, and an increased risk of bile duct injury caused by insertion of a porcine tissues covering the samples became thicker. 6 FC is a simple navigation tool for obtaining a biliary roadmap to transcystic tube. Intraoperative ultrasonography is also an established modality for confirming the bile duct anatomy reach the ‘‘critical view of safety’’ during LC. Key factors for better bile 3 duct identification by FC are administration of ICG as far in advance as and presence of gallstones during LC ; however, it requires considerable skill to scan the biliary tract and interpret cross- sectional ultrasonographic images.7 Editor: Wafi Attaallah. Received: March 3, 2015; revised: May 20, 2015; accepted: May 21, 2015. A novel IOC technique that utilizes the fluorescence of From Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, indocyanine green (ICG) excreted in the bile after intravenous Graduate School of Medicine, the University of Tokyo, Tokyo, Japan (YK, injection was recently developed for use in open surgery.8 Later, TI, KT, NH, JK, NK); Department of Gastroenterological Surgery, Cancer as laparoscopic/robotic fluorescence imaging systems became Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan (TI, AS); and Department of Surgery, Tokyo Yamate Medical Center, commercially available, this technique began to be applied in Japan Community Health Care Organization, Tokyo, Japan (NH, YB). the clinical setting during laparoscopic/robotic cholecystect- Reprints: Takeaki Ishizawa, Department of Gastroenterological Surgery, omy worldwide, including in Japan,9,10 the United States,11,12 Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3- Europe, 13–15 and Argentina.16 These previous series, including 8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan (e-mail: tish-tky @umin.ac.jp). our own, have suggested the potential advantage of fluorescence This work was supported by grants from the Takeda Science Foundation; the cholangiography (FC) with respect to its ability to enable real- Mochida Memorial Foundation for Medical and Pharmaceutical time identification of the extrahepatic bile ducts during dissec- Research; the Ministry of Education, Culture, Sports, Science and tion of Calot’s triangle, without exposing either the patient or Technology of Japan; and the Ministry of Health, Labour and Welfare of Japan. the surgical team to irradiation. However, the clinical and The authors have no conflicts of interest to disclose. technical factors that may affect the ability of FC to delineate Copyright # 2015 Wolters Kluwer Health, Inc. All rights reserved. the bile duct anatomy remain unclear because of the insufficient This is an open access article distributed under the Creative Commons size of the study population and lack of comparative data on the Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. bile duct detectability among fluorescence imaging systems. ISSN: 0025-7974 The aim of this study was to demonstrate the optimal conditions DOI: 10.1097/MD.0000000000001005 and technical details of FC that will allow it to be used widely Medicine Volume 94, Number 25, June 2015 www.md-journal.com | 1 Kono et al Medicine Volume 94, Number 25, June 2015 and efficiently as an intraoperative navigation tool of the bile light source in the laparoscopic imaging system (Figure 1A). duct anatomy during LC. Calot’s triangle is then dissected to reach the ‘‘critical view of safety,’’19 using FC to confirm the presence or absence of the accessory bile ducts at any time during the procedures. Fluor- METHODS escence images of the bile ducts should be obtained from both the This observational study was conducted with the approval of ventral and dorsal aspects of Calot’s triangle (Figure 1B and C, the institutional ethics committees and registered in the UMIN see Video, Supplementary Video 1, http://links.lww.com/MD/ Clinical Trials Registry (registration number UMIN000001075; A307 [Supplementary Video 1. Techniques of FC during dis- http://www.umin.ac.jp/ctr/index.htm). Informed consent was section of Calot’s triangle in LC, 3 minutes 48 seconds, 97MB], obtained from all of the patients. which demonstrates techniques of FC during LC). Finally, the cystic duct (CyD) is closed and then divided after confirming that Principle of ICG-Fluorescence Imaging no fluorescing structures exist with the exception of the CyD ICG binds to plasma proteins. When illuminated with near- between the gallbladder and the common hepatic duct (CHD). infrared light, the protein-bound ICG emits light with a peak 17 wavelength of about 830 nm. We hypothesized that fluor- Evaluation 1: Clinical Factors Affecting Bile Duct escence imaging following intravenous injection of ICG could Detectability by FC provide images of the biliary tract because ICG is excreted exclusively into the bile and human bile contains plasma proteins that bind with ICG. Biliary excretion of ICG starts Patients within minutes after intravenous injection, peaking within The study subjects comprised 108 patients who underwent 2 hours and continuing for as long as 20 hours.18 LC from July 2008 to October 2012 at the Tokyo Yamate Medical Center (Tokyo, Japan) or The University of Tokyo Hospital. Thirteen patients were excluded from the study Fluorescence Cholangiography Techniques because the fluorescence imaging system was unavailable on During LC the day of surgery. A concomitant diagnosis of common bile First, 1 mL of ICG (2.5 mg/mL; Daiichi Sankyo Co., duct (CBD) stones was made in 6 patients, who underwent Tokyo, Japan) is intravenously injected prior to the surgery. endoscopic retrograde cholangiography performed prior to LC When ICG is administered during surgery, fluorescence images (n ¼ 5) or by simultaneous laparoscopic choledocholithotomy of the bile ducts should be obtained at least 15 minutes after the (n ¼ 1). Laparoscopic gastric wedge resection was performed in intravenous injection so that the ICG is sufficiently washed out one patient, and lymph node dissection to treat gallbladder from the connective tissues around the bile ducts. The fluor- cancer was performed following LC in another patient. escence in the bile ducts can persist for more than 7 hours The patients comprised 49 men and 59 women with a median following the administration of ICG.9 age of 56 years (range, 19–82 years). The median body mass
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