ABSTRACT
Significance: This third biennial intraoperative molecular imaging (IMI) conference shows how optical contrast agents have been applied to develop clinically significant endpoints that improve precision cancer surgery. Aim: National and international experts on IMI presented ongoing clinical trials in cancer surgery and preclinical work. Previously known dyes (with broader applications), new dyes, novel nonfluorescence-based imaging techniques, pediatric dyes, and normal tissue dyes were discussed. Approach: Principal investigators presenting at the Perelman School of Medicine Abramson Cancer Center's third clinical trials update on IMI were selected to discuss their clinical trials and endpoints. Results: Dyes that are FDA-approved or currently under clinical investigation in phase 1, 2, and 3 trials were discussed. Sections on how to move benchwork research to the bedside were also included. There was also a dedicated section for pediatric dyes and nonfluorescence-based dyes that have been newly developed. Conclusions: IMI is a valuable adjunct in precision cancer surgery and has broad applications in multiple subspecialties. It has been reliably used to alter the surgical course of patients and in clinical decision making. There remain gaps in the utilization of IMI in certain subspecialties and potential for developing newer and improved dyes and imaging techniques.
Subject(s)
Neoplasms , Humans , Child , Neoplasms/diagnostic imaging , Neoplasms/surgery , Contrast Media , Molecular Imaging/methods , Coloring AgentsABSTRACT
The fluorescent imaging agent IS-001 was determined to be well tolerated in all subjects and has the potential to provide ureter visualization throughout minimally invasive hysterectomy procedures. This study was conducted to evaluate clinical safety and efficacy of a real-time ureter visualization technique for use during hysterectomy surgery. The study drug appears safe, is renally excreted, and allows enhanced ureter visualization when imaged with a clinically approved near-infrared sensitive endoscope. This is a first-in-human study showing preliminary results that the drug is safe and effective during surgery for improved ureter visualization.
Subject(s)
Fluorescent Dyes/administration & dosage , Hysterectomy/methods , Laparoscopy/methods , Monitoring, Intraoperative/methods , Spectroscopy, Near-Infrared/methods , Ureter/diagnostic imaging , Adult , Female , Humans , Middle Aged , Surgery, Computer-Assisted/methods , Young AdultABSTRACT
OBJECTIVE: To compare perioperative outcomes between robotic-assisted benign hysterectomies and abdominal, vaginal, and laparoscopic hysterectomies when performed by high-volume surgeons. METHODS: A multicenter data analysis compared 30-day outcomes from consecutive robotic-assisted hysterectomies performed by high-volume surgeons (≥60 prior procedures) at nine centers with records retrieved from the Premier Perspective database for abdominal, vaginal, and laparoscopic hysterectomies performed by high-volume gynecologic surgeons. Data on benign hysterectomy disorders from January 1, 2012 to September 30, 2013 were included. RESULTS: Data from 2300 robotic-assisted, 9745 abdominal, 8121 vaginal, and 11 952 laparoscopic hysterectomies were included. The robotic-assisted patient cohort had a significantly higher rate of adhesive disease compared with the vaginal (P<0.001) and laparoscopic cohorts (P<0.001), a significantly higher rate of morbid obesity than the vaginal (P<0.001) or laparoscopic cohorts (P<0.001), and a significantly higher rate of large uteri (>250g) than the abdominal (P<0.001), vaginal (P<0.001), or laparoscopic cohorts (P=0.017). The robotic-assisted cohort experienced significantly fewer intraoperative complications than the abdominal (P<0.001) and vaginal cohorts (P<0.001), and experienced significantly fewer postoperative complications compared with all the comparator cohorts (P<0.001). CONCLUSION: When performed by gynecologic surgeons with relevant high-volume experience, robotic-assisted benign hysterectomy provided improved outcomes compared with abdominal, vaginal, and laparoscopic hysterectomy.
Subject(s)
Hysterectomy/methods , Intraoperative Complications/epidemiology , Laparoscopy , Postoperative Complications/epidemiology , Robotic Surgical Procedures , Abdomen/surgery , Adult , Female , Humans , Middle Aged , Retrospective Studies , Treatment Outcome , United States , Vagina/surgeryABSTRACT
STUDY OBJECTIVE: To compare the perioperative outcomes, including estimated blood loss, conversion to open laparotomy, length of stay, and total operative time of hysterectomies using robotic-assisted, single-site laparoscopy with laparoendoscopic single site (LESS) for benign indications. DESIGN: A retrospective cohort study (Canadian Task Force classification Level II-2. SETTING: Multicenter (private hospitals). PATIENTS: Gynecologic patients who underwent a hysterectomy for benign indications via robotic-assisted, single-site laparoscopy (n = 50) versus LESS (n = 50). INTERVENTIONS: Observational study. MEASUREMENTS AND MAIN RESULTS: Continuous outcomes were analyzed using multiple linear regression, whereas the dichotomous outcome of conversion was analyzed using a multiple log-binomial regression model. Linear and log-binomial regression coefficients were adjusted for the ages of the patients and other clinical factors. A total of 100 consecutive patient records were available for analysis: 50 for robotic-assisted, single-site laparoscopy and 50 for LESS. Univariate analyses revealed that both groups were similar in mean age (robotic, 46.0 years; LESS, 45.4 years; p = .75), but not mean body mass index (robotic, 25.9 kg/m(2); LESS, 28.8 kg/m(2); p = .02). There was no difference in the unadjusted (crude) risk of conversion to a multiport procedure between the robotic and laparoscopic groups (p = .37). There were only 2 major complications (cystotomy and vaginal dehiscence) in the LESS arm and 1 vaginal dehiscence in the robotic-assisted, single-site arm. After adjusting for 7 potential confounders, no relationship was detected between the type of approach (robotic vs laparoscopic) and the outcome of a major complication (exact odds ratio, 0.55; exact p = 1.0). A multivariate linear regression analysis that compared the 2 groups (robotic-assisted single site vs LESS) revealed no differences in estimated blood loss. On average, the robotic-assisted, single-site group had a length of stay that was 8.12 hours shorter than the LESS group (p = .003) after adjusting for patient characteristics. Total operative time was an average of 24.9 min longer in the robotic-assisted, single-site group (p = .002) after adjustment. A plot of total operative time in minutes by chronological case number and procedural approach was analyzed to estimate a learning curve. This plot showed a steeper learning curve with the robotic-assisted, single-site approach. CONCLUSIONS: This preliminary observational study found that the robotic-assisted, single-site group had a statistically significant decrease in length of hospital stay, but also experienced an increase in total operative time. There were no conversions to open laparotomies.