Use of fluorescence imaging and indocyanine green during laparoscopic cholecystectomy: Results of an international Delphi survey.

BACKGROUND: Published empirical data have increasingly suggested that using near-infrared fluorescence cholangiography during laparoscopic cholecystectomy markedly increases biliary anatomy visualization. The technology is rapidly evolving, and different equipment and doses may be used. We aimed to identify areas of consensus and nonconsensus in the use of incisionless near-infrared fluorescent cholangiography during laparoscopic cholecystectomy. METHODS: A 2-round Delphi survey was conducted among 28 international experts in minimally invasive surgery and near-infrared fluorescent cholangiography in 2020, during which respondents voted on 62 statements on patient preparation and contraindications (n = 12); on indocyanine green administration (n = 14); on potential advantages and uses of near-infrared fluorescent cholangiography (n = 18); comparing near-infrared fluorescent cholangiography with intraoperative x-ray cholangiography (n = 7); and on potential disadvantages of and required training for near-infrared fluorescent cholangiography (n = 11). RESULTS: Expert consensus strongly supports near-infrared fluorescent cholangiography superiority over white light for the visualization of biliary structures and reduction of laparoscopic cholecystectomy risks. It also offers other advantages like enhancing anatomic visualization in obese patients and those with moderate to severe inflammation. Regarding indocyanine green administration, consensus was reached that dosing should be on a milligrams/kilogram basis, rather than as an absolute dose, and that doses >0.05 mg/kg are necessary. Although there is no consensus on the optimum preoperative timing of indocyanine green injections, the majority of participants consider it important to administer indocyanine green at least 45 minutes before the procedure to decrease the light intensity of the liver. CONCLUSION: Near-infrared fluorescent cholangiography experts strongly agree on its effectiveness and safety during laparoscopic cholecystectomy and that it should be used routinely, but further research is necessary to establish optimum timing and doses for indocyanine green.

Use of fluorescence imaging and indocyanine green during colorectal surgery: Results of an intercontinental Delphi survey.

BACKGROUND: Fluorescence imaging with indocyanine green is increasingly being used in colorectal surgery to assess anastomotic perfusion, and to detect sentinel lymph nodes. METHODS: In this 2-round, online, Delphi survey, 35 international experts were asked to vote on 69 statements pertaining to patient preparation and contraindications to fluorescence imaging during colorectal surgery, indications, technical aspects, potential advantages/disadvantages, and effectiveness versus limitations, and training and research. Methodological steps were adopted during survey design to minimize risk of bias. RESULTS: More than 70% consensus was reached on 60 of 69 statements, including moderate-strong consensus regarding fluorescence imaging's value assessing anastomotic perfusion and leak risk, but not on its value mapping sentinel nodes. Similarly, although consensus was reached regarding most technical aspects of its use assessing anastomoses, little consensus was achieved for lymph-node assessments. Evaluating anastomoses, experts agreed that the optimum total indocyanine green dose and timing are 5 to 10 mg and 30 to 60 seconds pre-evaluation, indocyanine green should be dosed milligram/kilogram, lines should be flushed with saline, and indocyanine green can be readministered if bright perfusion is not achieved, although how long surgeons should wait remains unknown. The only consensus achieved for lymph-node assessments was that 2 to 4 injection points are needed. Ninety-six percent and 100% consensus were reached that fluorescence imaging will increase in practice and research over the next decade, respectively. CONCLUSION: Although further research remains necessary, fluorescence imaging appears to have value assessing anastomotic perfusion, but its value for lymph-node mapping remains questionable.

Consensus Conference Statement on the General Use of Near-infrared Fluorescence Imaging and Indocyanine Green Guided Surgery: Results of a Modified Delphi Study.

BACKGROUND: In recent decades, the use of near-infrared light and fluorescence-guidance during open and laparoscopic surgery has exponentially expanded across various clinical settings. However, tremendous variability exists in how it is performed. OBJECTIVE: In this first published survey of international experts on fluorescence-guided surgery, we sought to identify areas of consensus and nonconsensus across 4 areas of practice: fundamentals; patient selection/preparation; technical aspects; and effectiveness and safety. METHODS: A Delphi survey was conducted among 19 international experts in fluorescence-guided surgery attending a 1-day consensus meeting in Frankfurt, Germany on September 8th, 2019. Using mobile phones, experts were asked to anonymously vote over 2 rounds of voting, with 70% and 80% set as a priori thresholds for consensus and vote robustness, respectively. RESULTS: Experts from 5 continents reached consensus on 41 of 44 statements, including strong consensus that near-infrared fluorescence-guided surgery is both effective and safe across a broad variety of clinical settings, including the localization of critical anatomical structures like vessels, detection of tumors and sentinel nodes, assessment of tissue perfusion and anastomotic leaks, delineation of segmented organs, and localization of parathyroid glands. Although the minimum and maximum safe effective dose of ICG were felt to be 1 to 2 mg and >10 mg, respectively, there was strong consensus that determining the optimum dose, concentration, route and timing of ICG administration should be an ongoing research focus. CONCLUSIONS: Although fluorescence imaging was almost unanimously perceived to be both effective and safe across a broad range of clinical settings, considerable further research remains necessary to optimize its use.

Fluorescence-based bowel anastomosis perfusion evaluation: results from the IHU-IRCAD-EAES EURO-FIGS registry.

BACKGROUND: Anastomotic leakage (AL) is one of the dreaded complications following surgery in the digestive tract. Near-infrared fluorescence (NIRF) imaging is a means to intraoperatively visualize anastomotic perfusion, facilitating fluorescence image-guided surgery (FIGS) with the purpose to reduce the incidence of AL. The aim of this study was to analyze the current practices and results of NIRF imaging of the anastomosis in digestive tract surgery through the EURO-FIGS registry. METHODS: Analysis of data prospectively collected by the registry members provided patient and procedural data along with the ICG dose, timing, and consequences of NIRF imaging. Among the included upper-GI, colorectal, and bariatric surgeries, subgroup analysis was performed to identify risk factors associated with complications. RESULTS: A total of 1240 patients were included in the study. The included patients, 74.8% of whom were operated on for cancer, originated from 8 European countries and 30 hospitals. A total of 54 surgeons performed the procedures. In 83.8% of cases, a pre-anastomotic ICG dose was administered, and in 60.1% of cases, a post-anastomotic ICG dose was administered. A significant difference (p < 0.001) was found in the ICG dose given in the four pathology groups registered (range: 0.013-0.89 mg/kg) and a significant (p < 0.001) negative correlation was found between the ICG dose and BMI. In 27.3% of the procedures, the choice of the anastomotic level was guided by means of NIRF imaging which means that in these cases NIRF imaging changed the level of anastomosis which was first decided based on visual findings in conventional white light imaging. In 98.7% of the procedures, the use of ICG partly or strongly provided a sense of confidence about the anastomosis. A total of 133 complications occurred, without any statistical significance in the incidence of complications in the anastomoses, whether they were ICG-guided or not. CONCLUSION: The EURO-FIGS registry provides an insight into the current clinical practice across Europe with respect to NIRF imaging of anastomotic perfusion during digestive tract surgery.

Assessing the development status of intraoperative fluorescence imaging for perfusion assessments, using the IDEAL framework.

OBJECTIVES: Intraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development, Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures. DESIGN: Narrative literature review with analysis of IDEAL stage of each field of study. SETTING: All publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery. MAIN OUTCOME MEASURES: The IDEAL stage of research evidence was determined for each specialty field using a previously described approach. RESULTS: 196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported. CONCLUSIONS: Using fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in planning further studies to establish the potential for patient benefit.

Incisionless fluorescent cholangiography (IFC): a pilot survey of surgeons on procedural familiarity, practices, and perceptions.

BACKGROUND: Incisionless fluorescent cholangiography (IFC) has recently been proven feasible, safe, and efficacious as an intraoperative procedure to help identify extrahepatic bile ducts during laparoscopic cholecystectomies (LC). We conducted a pilot survey of 51 surgeons attending an international conference who perform endoscopic cholecystectomies to identify their typical LC practices, and perceptions of IFC. METHODS: An international panel of ten IFC experts, all with > 500 prior IFC procedures and related research publications, convened during the 4th International Congress of Fluorescence-Guided Surgery in Boca Raton, Florida in February 2017. The panel was charged with developing questions about LC practices and experience with IFC, and perceptions regarding its advantages, barriers to use, and indications. These questions then were asked to other congress attendees during one of the didactic sessions using an online polling application. Attendees, who ranged from zero to considerable experience performing IFC, accessed the survey via their portable devices. RESULTS: Of the 51 survey participants, 51% were from North America; 77% identified themselves as general/minimally invasive surgeons, and roughly 60% performed under 50 cholecystectomies/year. Only 12% performed routine intraoperative cholangiography (IOC), while 72.3% routinely performed critical safety reviews. Thirty-five percent estimated that their institution's laparoscopic-to-open surgery conversion rate was > 1% during LC. Roughly 95% of respondents felt that surgeons should have access to a noninvasive method for evaluating extrahepatic biliary structures; 84% felt that the most advantageous characteristic of IFC is the lack of any biliary-tree incision; and 93.3% felt that IFC would have considerable educational value in surgical training programs; and 78% felt that any surgeon who performs LC could benefit. CONCLUSIONS: Surgeons who participated in our survey overwhelmingly recommended the routine use of IFC during laparoscopic cholecystectomy as a complimentary imaging technique. Prospective randomized clinical trials remain necessary to determine whether IFC reduces the incidence of bile duct injuries and other LC complications.

Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography.

BACKGROUND: Incisionless near-infrared fluorescent cholangiography (NIFC) is emerging as a promising tool to enhance the visualization of extrahepatic biliary structures during laparoscopic cholecystectomies. METHODS: We conducted a single-blind, randomized, 2-arm trial comparing the efficacy of NIFC (n = 321) versus white light (WL) alone (n = 318) during laparoscopic cholecystectomy. Using the KARL STORZ Image1 S imaging system with OPAL1 technology for NIR/ICG imaging, we evaluated the detection rate for 7 biliary structures-cystic duct (CD), right hepatic duct (RHD), common hepatic duct, common bile duct, cystic common bile duct junction, cystic gallbladder junction (CGJ), and accessory ducts -before and after surgical dissection. Secondary calculations included multivariable analysis for predictors of structure visualization and comparing intergroup biliary duct injury rates. RESULTS: Predissection detection rates were significantly superior in the NIFC group for all 7 biliary structures, ranging from 9.1% versus 2.9% to 66.6% versus 36.6% for the RHD and CD, respectively, with odds ratios ranging from 2.3 (95% CI 1.6-3.2) for the CGJ to 3.6 (1.6-9.3) for the RHD. After dissection, similar intergroup differences were observed for all structures except CD and CGJ, for which no differences were observed. Significant odds ratios ranged from 2.4 (1.7-3.5) for the common hepatic duct to 3.3 (1.3-10.4) for accessory ducts. Increased body mass index was associated with reduced detection of most structures in both groups, especially before dissection. Only 2 patients, both in the WL group, sustained a biliary duct injury. CONCLUSIONS: In a randomized controlled trial, NIFC was statistically superior to WL alone visualizing extrahepatic biliary structures during laparoscopic cholecystectomy. REGISTRATION NUMBER: NCT02702843.

The use of 3D laparoscopic imaging systems in surgery: EAES consensus development conference 2018.

BACKGROUND: The use of 3D laparoscopic systems is expanding. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference with the aim of creating evidence-based statements and recommendations for the surgical community. METHODS: Systematic reviews of the PubMed and Embase libraries were performed to identify evidence on potential benefits of 3D on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by an international surgical and engineering expert panel which were presented and voted at the EAES annual congress, London, May 2018. RESULTS: 9967 abstracts were screened with 138 articles included. 18 statements and two recommendations were generated and approved. 3D significantly shortened operative time (mean difference 11 min (8% [95% CI 20.29-1.72], I2 96%)). A significant reduction in complications was observed when 3D systems were used (RR 0.75, [95 CI% 0.60-0.94], I2 0%) particularly for cases involving laparoscopic suturing (RR 0.57 [95% CI 0.35-0.90], I2 0%). In 69 box trainer or simulator studies, 64% concluded trainees were significant faster and 62% performed fewer errors when using 3D. CONCLUSION: We recommend the use of 3D vision in laparoscopy to reduce the operative time (grade of recommendation: low). Future robust clinical research is required to specifically investigate the potential benefit of 3D laparoscopy system on complication rates (grade of recommendation: high).

Pre- and Postbariatric Subtypes and Their Predictive Value for Health-Related Outcomes Measured 3 Years After Surgery.

BACKGROUND: Although bariatric surgery is the most effective treatment for severe obesity, a subgroup of patients shows insufficient postbariatric outcomes. Differences may at least in part result from heterogeneous patient profiles regarding reactive and regulative temperament, emotion dysregulation, and disinhibited eating. This study aims to subtype patients based on these aspects before and 2 years after bariatric surgery and tests the predictive value of identified subtypes for health-related outcomes 3 years after surgery. METHODS: Within a prospective multicenter patient registry, N = 229 bariatric patients were examined before bariatric surgery, 2 and 3 years postoperatively via clinical interviews and self-report questionnaires. Pre- and postbariatric subtypes were differentiated by temperament, emotion dysregulation, and disinhibited eating using latent profile analyses (LPA). The predictive value of pre- and postbariatric subtypes for surgery outcomes measured 3 years postoperatively was tested via linear regression analyses. RESULTS: LPA resulted in five prebariatric and three postbariatric subtypes which were significantly associated with different levels of general and eating disorder psychopathology. Post- versus prebariatric subtypes explained more variance regarding eating disorder psychopathology, depression, and quality of life assessed 3 years postoperatively, whereas neither pre- nor postbariatric subtypes predicted postbariatric weight loss. Patients with prebariatric deficits in self- and emotional control had an increased risk for showing these deficits postoperatively. CONCLUSIONS: A re-evaluation of patients' psychological status after bariatric surgery is recommended to detect patients with potential risk for adverse psychological surgery outcomes in the long term.

Achieving high quality standards in laparoscopic colon resection for cancer: A Delphi consensus-based position paper.

AIM: To investigate the rate of laparoscopic colectomies for colon cancer using registries and population-based studies. To provide a position paper on mini-invasive (MIS) colon cancer surgery based on the opinion of experts leader in this field. METHODS: A systematic review of the literature was conducted using PRISMA guidelines for the rate of laparoscopy in colon cancer. Moreover, Delphi methodology was used to reach consensus among 35 international experts in four study rounds. Consensus was defined as an agreement ≥75.0%. Domains of interest included nosology, essential technical/oncological requirements, outcomes and MIS training. RESULTS: Forty-four studies from 42 articles were reviewed. Although it is still sub-optimal, the rate of MIS for colon cancer increased over the years and it is currently >50% in Korea, Netherlands, UK and Australia. The remaining European countries are un-investigated and presented lower rates with highest variations, ranging 7-35%. Using Delphi methodology, a laparoscopic colectomy was defined as a "colon resection performed using key-hole surgery independently from the type of anastomosis". The panel defined also the oncological requirements recognized essential for the procedure and agreed that when performed by experienced surgeons, it should be marked as best practice in guidelines, given the principles of oncologic surgery be respected (R0 procedure, vessel ligation and mesocolon integrity). CONCLUSION: The rate of MIS colectomies for cancer in Europe should be further investigated. A panel of leaders in this field defined laparoscopic colectomy as a best practice procedure when performed by an experienced surgeon respecting the standards of surgical oncology.

Identifying prebariatric subtypes based on temperament traits, emotion dysregulation, and disinhibited eating: A latent profile analysis.

OBJECTIVE: The efficacy of bariatric surgery has been proven; however, a subset of patients fails to achieve expected long-term weight loss postoperatively. As differences in surgery outcome may be influenced by heterogeneous psychological profiles in prebariatric patients, previous subtyping models differentiated patients based on temperament traits. The objective of this study was to expand these models by additionally considering emotion dysregulation and disinhibited eating behaviors for subtyping, as these factors were associated with maladaptive eating behaviors and poor postbariatric weight loss outcome. METHOD: Within a prospective multicenter registry, N = 370 prebariatric patients were examined using interview and self-report questionnaires. A latent profile analysis was performed to identify subtypes based on temperament traits, emotion dysregulation, and disinhibited eating behaviors. RESULTS: Five prebariatric subtypes were identified with specific profiles regarding self-control, emotion dysregulation, and disinhibited eating behaviors. Subtypes were associated with different levels of eating disorder psychopathology, depression, and quality of life. The expanded model increased variance explanation compared to temperament-based models. CONCLUSION: By adding emotion dysregulation and disinhibited eating behaviors to previous subtyping models, specific prebariatric subtypes emerged with distinct psychological deficit patterns. Future investigations should test the predictive value of these subtypes for postbariatric weight loss and health-related outcomes.

Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

BACKGROUND: Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). METHODS: This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). RESULTS: The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups. CONCLUSIONS: In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

Laparoscop fluorescence angiography with indocyanine green to control the perfusion of gastrointestinal anastomoses intraoperatively.

The principle of fluorescence angiography using indocyanine green has been known for a long time and was used especially by photographs and ophthalmologists for retinal diagnostics. After one publication about perfusion control in open surgery we were the first who examined the perfusion of colorectal anastomoses by laparoscopic fluorescence angiography intraoperatively. Since 2008, 49 laparoscopic operations (45 colorectal anastomoses, 4 gastric sleeve resections) were performed using the fluorescence control. In all cases a correct perfusion of the anastomotic/stapler region could be shown. In cases of decreased perfusion a resection of this area could have been necessary. The laboratory tests with isolated, perfused pig colon could show areas with hypoperfusion after dissection of segmental arteries. Laparoscopic fluorescence angiography could become a standard method to detect a decreased perfusion intraoperatively. Further studies will be needed to show if the rate of anastomotic insufficiency can be lowered by using this new method.

Collateral tissue damage by several types of coagulation (monopolar, bipolar, cold plasma and ultrasonic) in a minimally invasive, perfused liver model.

Hemostasis in minimally invasive surgery causes tissue damage. Regardless of the method of production of thermal energy, a quick and safe coagulation is essential for its clinical use. In this study we examined the tissue damage in the isolated perfused pig liver using monopolar, bipolar, cold plasma, and ultrasonic coagulation. In a minimally invasive in vitro setup, a 2-3 cm slice of the edge of the perfused pig liver was resected. After hemostasis was achieved, liver tissue of the coagulated area was given to histopathological examination. The depth of tissue necrosis, the height of tissue loss, and the time until sufficient hemostasis was reached were analyzed. The lowest risk for extensive tissue damage could be shown for the bipolar technique, combined with the highest efficiency in hemostasis. Using cold plasma, coagulation time was longer with a deeper tissue damage. Monopolar technique showed the worst results with the highest tissue damage and a long coagulation time. Ultrasonic coagulation was not useful for coagulation of large bleeding areas. In summary, bipolar technique led to less tissue damage and best coagulation results in our minimally invasive model. These results could be important to recommend bipolar coagulation for clinical use in minimally invasive surgery.

Laparoscopic reversal of Hartmann's procedure: technique and results.

Reversal of Hartmann's procedure is associated with a high morbidity and mortality leading to a low rate of intestinal restoration. We investigated whether the laparoscopic reversal is safely feasible and offers any advantage to the patient. The reversal operation was performed in 28 of 34 patients after Hartmann's procedure. The laparoscopic reversal of Hartmann's procedure had a short operative time (69 min) and a conversion rate of 17.9%. Wound complications occurred in 10.7%, an anastomosic leak in 1 patient (3.6%). On average the patients were discharged after 8.6 (6 to 17) postoperative days. We conclude that the laparoscopic reversal of Hartmann's procedure is a technically demanding but feasible operation with a low postoperative morbidity and mortality. We recommend the laparoscopic approach, which could be favorable compared with historical open series.