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不同剂量吲哚菁绿在日间腹腔镜胆囊切除术荧光胆管造影中效果比较——一项多中心随机对照试验
张轶西, 靖超, 郑亚民, 王达庆, 任志刚, 郭伟
中国实用外科杂志 ›› 2025, Vol. 45 ›› Issue (11) : 1283-1288.
PDF(2872 KB)
PDF(2872 KB)
不同剂量吲哚菁绿在日间腹腔镜胆囊切除术荧光胆管造影中效果比较——一项多中心随机对照试验
The application value of optimizing the administration regimen of indocyanine green in day surgery laparoscopic cholecystectomy - a multicenter randomized controlled clinical study
目的 探讨日间腹腔镜胆囊切除术（DSLC）肝外胆管显影中吲哚菁绿（ICG）不同给药剂量、给药时间的效果。方法 前瞻性纳入2023年1月至2024年12月在首都医科大学附属北京友谊医院（639例）、民航总医院（45例）、北京市昌平区医院（34例）、首都医科大学宣武医院（82例）行DSLC的800例病人，术前30 min静脉注射4种不同剂量的ICG（2、4、8、16 μg/kg体重），评估术中3个时间点（游离胆囊三角区前、游离胆囊三角区后、离断胆囊颈管后）胆总管和肝脏的荧光强度并计算胆管肝脏荧光比值（BLR）。结果 800例病人按生成随机数法分为4组，最终784例病人纳入分析，其中2 μg/kg组198例、4 μg/kg组196例、8 μg/kg组198例、16 μg/kg组192例。各组病人的术前基线特征差异无统计学意义（P>0.05）。2 μg/kg组的胆管和肝脏的荧光强度均较小，16 μg/kg组在3个时间点的胆管和肝脏背景中的荧光强度值均较高。4 μg/kg组的胆管中可见较强的荧光强度，肝脏背景中的荧光强度较低。随着ICG剂量的增加，肝脏背景（F=2.416，P=0.133）和胆管中的荧光强度（F=4.205，P=0.031）在3个时间点均逐渐升高而BLR趋势不明显（P=0.113），4 μg/kg组平均BLR高于2 μg/kg、8 μg/kg和16 μg/kg组，差异有统计学意义（2.12 vs. 1.18 vs. 1.49 vs. 1.32，P=0.005）。结论 对于日间的荧光腹腔镜胆囊切除术而言，在术前30 min静脉注射4 μg/kg的ICG，是实时荧光胆道显像的合适方案。
Objective To investigate the effects of different doses and administration times of indocyanine green (ICG) in the visualization of extrahepatic bile ducts during daytime laparoscopic cholecystectomy (DSLC). Methods A total of 800 patients who underwent DLC surgery at Beijing Friendship Hospital of Capital Medical University (639 cases), Civil Aviation General Hospital (45 cases), Changping District Hospital of Beijing (34 cases), and Xuanwu Hospital of Capital Medical University (82 cases) between January 2023 and December 2024 were prospectively included. The patients were intravenously injected with four different doses of ICG (2, 4, 8, and 16 μg/kg) 30 minutes before the operation. The fluorescence intensity of the common bile duct and liver at three time points during the operation (before the free gallbladder triangle area, after the free gallbladder triangle area, and after the disconnection of the gallbladder neck tube) and the bile duct-liver fluorescence ratio (BLR) at these three time points were evaluated. Results The 800 patients were randomly divided into four groups using a random number generation method. Finally, 784 patients were included in the analysis, including 198 cases in the 2 μg/kg group, 196 cases in the 4 μg/kg, 198 cases in the 8 μg/kg, and 192 cases in the 16 μg/kg. There was no statistically significant difference in the baseline characteristics of the patients among the four groups (P>0.05). The fluorescence intensity of the bile duct and liver in 2 μg/kg group was smaller, while the fluorescence intensity of the bile duct and liver background in 16 μg/kg group was higher at the three time points. Strong fluorescence intensity was observed in the bile duct of 4 μg/kg group, and the fluorescence intensity of the liver background was lower. With the increase in ICG dose, the fluorescence intensity of the liver background (F=2.416, P=0.133) and bile duct (F=4.205, P=0.031) at three time points gradually increased. The BLR did not show a significant upward trend with the increase in ICG dose (P=0.113). The average BLR of 4 μg/kg group was higher than that of groups 2, 8, and 16 μg/kg group, and the difference was statistically significant (2.12 vs. 1.18 vs. 1.49 vs. 1.32, P=0.005). Conclusion For daytime fluorescence laparoscopic cholecystectomy, intravenous injection of 4 μg/kg of ICG 30 minutes before the operation is an appropriate scheme for real-time fluorescence biliary imaging.
吲哚菁绿剂量 / 腹腔镜胆囊切除术 / 日间手术 / 胆管肝脏荧光比值 / 荧光强度
indocyanine green dose / laparoscopic cholecystectomy / day surgery / biliary liver fluorescence ratio / fluorescence intensity
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Since the introduction of laparoscopic cholecystectomy (LC), a substantial increase in bile duct injury (BDI) incidence was noted. Multiple methods to prevent this complication have been developed and investigated. The most suitable method however is subject to debate. In this systematic review, the different modalities to aid in the safe performance of LC and prevent BDI are delineated.A systematic search for articles describing methods for the prevention of BDI in LC was conducted using EMBASE, Medline, Web of science, Cochrane CENTRAL and Google scholar databases from inception to 11 June 2018.90 studies were included in this systematic review. Overall, BDI preventive techniques can be categorized as dedicated surgical approaches (Critical View of Safety (CVS), fundus first, partial laparoscopic cholecystectomy), supporting imaging techniques (intraoperative radiologic cholangiography, intraoperative ultrasonography, fluorescence imaging) and others. Dedicated surgical approaches demonstrate promising results, yet limited research is provided. Intraoperative radiologic cholangiography and ultrasonography demonstrate beneficial effects in BDI prevention, however the available evidence is low. Fluorescence imaging is in its infancy, yet this technique is demonstrated to be feasible and larger trials are in preparation.Given the low sample sizes and suboptimal study designs of the studies available, it is not possible to recommend a preferred method to prevent BDI. Surgeons should primarily focus on proper dissection techniques, of which CVS is most suitable. Additionally, recognition of hazardous circumstances and knowledge of alternative techniques is critical to complete surgery with minimal risk of injury to the patient.Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
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郭伟, 佟奎南, 刘坤. 胆肠吻合术后肝内胆管结石防治研究进展[J]. 中国实用外科杂志, 2024, 44(3): 346-348. DOI:10.19538/j.cjps.issn1005-2208.2024.03.22.
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Day-case laparoscopic cholecystectomy (DCLC) is not universally adopted and its use is limited to patients selected by non-standardized criteria. Since laparoscopic cholecystectomy is considered technically more difficult in obese patients, a high body mass index (BMI) is often considered an exclusion criterion for DCLC. The aim of this research is to define the feasibility and safety of day case laparoscopic cholecystectomy in obese patients.Data from 730 consecutive patients preoperatively considered suitable for DCLC were analysed. BMI was not considered as parameter of selection and patients were divided in two groups (Obese, 294; Non-obese, 436) according to a BMI ≥ 30 or < 30 kg/m, respectively. Outcomes measured were morbidity, open conversion rates, hospitalization rates, length of hospital stay and readmission. Overall morbidity and open conversion rates were similar in both groups. No significant differences were observed among the two groups in terms of hospitalization rates (p 0.0533), early complications (p 0.2536), length of hospital stay (p 0.3780) and readmission rates (p 0.4286).Day case laparoscopic cholecystectomy is a widely used surgical technique despite not routinely used in every health system. However, many factors related to the patient and procedure, as well as the expertise of surgical-anesthesiologist team, can influence the feasibility of DCLC. Moreover a well-organized health community system is necessary to protect and follow the patients up. Our readmission and complication rates showed how a day case laparoscopic cholecystectomy, if performed in the right setting, is a safe procedure also for patient with a raised BMI. We enrolled a large population of patients and the statistical analysis demonstrated no significant differences among the obese and non-obese patient regarding the primary and secondary endpoints.DCLC is a safe and effective procedure in obese patients with morbidity, hospital admission and readmission rates similar to those observed in non-obese patients.Copyright © 2017. Published by Elsevier Ltd.
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Delayed discharge is the existing obstacle to further enhancing quality of recovery after Day-surgery laparoscopic cholecystectomy (LC/DS). This study aims to analyze the reasons for delayed discharge after LC/DS.The 745 patients with delayed discharge after LC/DS were retrospectively studied. The reasons for delayed discharge and data related to patients were collected and analyzed. Psychosocial reasons were defined by meeting discharge criteria but refusing to discharge, and complications were defined and graded using the "Clavien-Dindo" classification system. Differences were statistically significant when p-value < 0.01 level.The reasons for delayed discharge included psychosocial reasons (P, n = 324), conversion to open surgery (CO, n = 21) and Clavien-Dindo I (n = 72), II (n = 307), IIIa (n = 17), IVa (n = 4) complications. Group P had a shorter length of postoperative hospital stay (PHT) compared to groups I, II, IIIa, IVa and CO (p < 0.01, respectively). Group II had a longer operation time (p < 0.01) but no longer length of PHT (p = 0.814) compared to group I. The length of PHT in group IIIa was longer than that in groups I and II (p < 0.01, respectively), but the length of PHT in group IVa was no longer than that in groups I, II, and IIIa (p = 0.047, p = 0.044 and p = 0.849, respectively). Group CO had a longer operation time (p < 0.01, respectively), a more blood loss (p < 0.01, respectively) and a longer length of PHT (p < 0.01, respectively) compared to groups P, I, II, and IIIa.Patients who are delayed discharge due to psychosocial reasons have a rapid postoperative recovery. The slower postoperative recovery and upgraded complication classifications are related and optimized medical procedures promote the recovery. It is reasonable for patients who undergo conversion to open surgery to experience a slow postoperative recovery.Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
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郭伟, 佟奎南, 吴鸿伟. 吲哚菁绿荧光显像在肝胆外科应用有效性的影响因素[J]. 国际外科学杂志, 2025, 52(4):284-288. DOI:10.3760/cma.j.cn115396-20240822-00258.
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Although intraoperative cholangiography has been recommended for avoiding bile duct injury during laparoscopic cholecystectomy, radiographic cholangiography is time consuming and may itself cause injury to the bile duct. Recently, a novel fluorescent cholangiography technique using the intravenous injection of indocyanine green (ICG) has been developed.
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Pancreatic surgery is a complex and challenging field, with patients facing a high risk of postoperative complications. In recent years, indocyanine green (ICG) has gained prominence as a valuable tool used in various aspects of pancreatic surgery. ICG is a fluorescent dye that offers real-time imaging capabilities that enhance the surgeon’s ability to accurately localize tumors and critical anatomical structures, thereby improving surgical precision and potentially reducing operative time and complications. One of the most significant advantages of ICG is its ability to provide enhanced visualization of the biliary tract and vascular structures, which is particularly beneficial in complex pancreatic resections, in which the anatomy can be highly variable and challenging to navigate. Furthermore, ICG can be instrumental in ensuring the adequate perfusion of anastomoses, thereby reducing the risk of postoperative leaks and associated morbidity. This comprehensive review aims to provide an in-depth analysis of the current applications, advantages, and limitations of ICG in pancreatic surgery.
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To establish consensus recommendations for the use of fluorescence imaging with indocyanine green (ICG) in hepatobiliary surgery.ICG fluorescence imaging has gained popularity in hepatobiliary surgery in recent years. However, there is varied evidence on the use, dosage, and timing of administration of ICG in clinical practice. To standardize the use of this imaging modality in hepatobiliary surgery, a panel of pioneering experts from the Asia-Pacific region sought to establish a set of consensus recommendations by consolidating the available evidence and clinical experiences.A total of 13 surgeons experienced in hepatobiliary surgery and/or minimally invasive surgery formed an expert consensus panel in Shanghai, China in October 2018. By the modified Delphi method, they presented the relevant evidence, discussed clinical experiences, and derived consensus statements on the use of ICG in hepatobiliary surgery. Each statement was discussed and modified until a unanimous consensus was achieved.A total of 7 recommendations for the clinical applications of ICG in hepatobiliary surgery were formulated.The Shanghai consensus recommendations offer practical tips and techniques to augment the safety and technical feasibility of ICG fluorescence-guided hepatobiliary surgery, including laparoscopic cholecystectomy, liver segmentectomy, and liver transplantation.Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.
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Indocyanine green (ICG) is a fluorescent dye with an emission wavelength of about 840 nm, which is selectively absorbed by the liver after intravenous or bile duct injection, and then it is excreted into the intestines through the biliary system. With the rapid development of fluorescence laparoscopy, ICG fluorescence imaging is safe, feasible, and widely used in hepatobiliary surgery. ICG fluorescence imaging is of great significance in precise preoperative and intraoperative localization of liver lesions, real-time visualization of hepatic segmental anatomy, intrahepatic and extrahepatic biliary tract visualization, and liver transplantation. ICG fluorescence imaging facilitates efficient intraoperative hepatobiliary decision-making and improves the safety of minimally invasive hepatobiliary surgery. Advances in imaging systems will increase the use of fluorescence imaging as an intraoperative navigation tool, improving the safety and accuracy of open and laparoscopic/robotic hepatobiliary surgery. Herin, we have reviewed the status of ICG applications in hepatobiliary surgery, aiming to provide new insights for the development of hepatobiliary surgery.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
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Though often only briefly described in the literature, there are clearly factors that have an influence on the fluorescence intensity, and thereby the usefulness of the technique. This article aims to provide an overview of the factors influencing the fluorescence intensity of fluorescence imaging with Indocyanine green, primarily focussed on NIRF guided cholangiography.A systematic search was conducted to gain an overview of currently used methods in NIRF imaging in laparoscopic cholecystectomies. Relevant literature was searched to gain advice on what methods to use. Ex vivo experiments were performed to assess various factors that influence fluorescence intensity and whether the found clinical advices can be confirmed.ICG is currently the most widely applied fluorescent dye. Optimal ICG concentration lies between 0.00195 and 0.025 mg/ml, and this dose should be given as early as achievable-but maximum 24 h-before surgery. When holding the laparoscope closer and perpendicular to the dye, the signal is most intense. In patients with a higher BMI and/or cholecystitis, fluorescence intensity is lower, but NIRF seems to be more helpful. There are differences between various marketed fluorescence systems. Also, no uniform method to assess fluorescence intensity is available yet.This study identified and discussed several factors that influence the signal of fluorescence cholangiography. These factors should be taken into account when using NIRF cholangiography. Also, surgeons should be aware of new dyes and clinical systems, in order to benefit most from the potential of NIRF imaging.
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This study aimed to investigate the indocyanine green (ICG) dose in real-time fluorescent cholangiography during laparoscopic cholecystectomy (LC) with a 4K fluorescent system. A randomized controlled clinical trial was conducted in patients who underwent LC for treatment of cholelithiasis. Using the OptoMedic 4K fluorescent endoscopic system, we compared four different doses of ICG (1, 10, 25, and 100 µg) administered intravenously within 30 min preoperatively and evaluated the fluorescence intensity (FI) of the common bile duct and liver background and the bile-to-liver ratio (BLR) of the FI at three timepoints: before surgical dissection of the cystohepatic triangle, before clipping the cystic duct, and before closure. Forty patients were randomized into four groups, and 33 patients were fully analyzed, with 10 patients in Group A (1 µg), 7 patients in Group B (10 µg), 9 patients in Group C (25 µg), and 7 patients in Group D (100 µg). The preoperative baseline characteristics were compared among groups (p > 0.05). Group A showed no or minimal FI in the bile duct and liver background, while Group D showed extremely high FIs in the bile duct and in the liver background at the three timepoints. Groups B and C presented with visible FI in the bile duct and low FI in the liver background. With increasing ICG doses, the FIs in the liver background and bile duct gradually increased at the three timepoints. The BLR, however, showed no increasing trend with an increasing ICG dose. A relatively high BLR on average was found in Group B, without a significant difference compared to the other groups (p > 0.05). An ICG dose ranging from 10 to 25 µg by intravenous administration within 30 min preoperatively was appropriate for real-time fluorescent cholangiography in LC with a 4K fluorescent system. Registration: This study was registered in the Chinese Clinical Trial Registry (ChiCTR No: ChiCTR2200064726).© 2023. The Author(s).
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Although recent advances in preoperative imaging have enabled accurate estimation of the regional liver volume with venous occlusion, the extent of functional decrease in such regions remains unclear. In this study, the portal uptake function in postoperative veno-occlusive regions and non-veno-occlusive regions was evaluated by intraoperative fluorescent imaging after intravenous injection of indocyanine green (ICG).In 22 liver resection patients and 23 recipients and 18 donors of liver transplantation, fluorescent intensity on the remnant liver or the liver graft was evaluated in real time following intravenous injection of ICG (0.0025 mg per 1 ml of remnant liver volume).Plateau ICG concentrations were significantly lower in the veno-occlusive regions (C(VO)) than in the non-veno-occlusive regions (C(Non)) in liver resection patients (median [range], 0.75 [0.29-2.0]μg/ml vs. 3.0 [0.46-6.4]μg/ml, p<0.001), donors (0.69 [0.29-1.9]μg/ml vs. 2.4 [0.46-6.4]μg/ml, p<0.001), and recipients (0.75 [0.34-1.8]μg/ml vs. 1.8 [0.54-6.4]μg/ml, p<0.001). Distributions of the C(VO)/C(Non) and the ratio of the hepatic uptake rate constant in the veno-occlusive regions to that in non-veno-occlusive regions were both around 40% (mean ± standard deviation, 0.36 ± 0.17 and 0.42 ± 0.16, respectively). When the functional remnant liver volume was calculated as a sum of non-veno-occlusive regions and veno-occlusive regions multiplied by C(VO)/C(Non), its ratio to the total liver volume was correlated with the improved postoperative/preoperative ratio of prothrombin time.Portal uptake function in veno-occlusive regions is approximately 40% of that in non-veno-occlusive regions. Intraoperative ICG-fluorescent imaging enables real-time evaluation of the extent of the functional decrease in veno-occlusive regions, enhancing accurate estimation of the hepatic functional reserve for determining the surgical indications and procedures.Copyright © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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