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Laparoscopic Thermal Cholangiography: a Novel Technique for Biliary Imaging

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Laparoscopic Thermal Cholangiography: a Novel Technique for Biliary Imaging Laparoscopic Thermal Cholangiography: A novel technique for biliary imaging Principal Investigator: Jonathan Pearl, MD Assistant Professor Department of Surgery University of Maryland School of Medicine Baltimore, MD 21230 [email protected] Total Funding Requested: $30,000 Statement of Funds There are no funds for this or related projects pending or available through other sources. Summary There have been few recent advances in advanced imaging for laparoscopic surgery. Generating novel methods of defining anatomy and augmenting surgeons’ capabilities is critical to improving patient outcomes. This is especially germane in laparoscopic cholecystectomy where cholangiography has been shown to reduce bile duct injury rates by 50%, yet surgeons perform cholangiography in less than half of cases. Thermal imaging is an available technology that has not yet been employed in surgery. Using a thermal camera, we have performed a pilot project showing that thermal cholangiography clearly demonstrates biliary anatomy. The images are similar to fluoroscopic cholangiograms yet require only the injection of saline and a handheld thermal camera. We propose a series of ex vivo experiments to optimize the conditions of thermal cholangiography and compare the accuracy of thermal cholangiograms with fluoroscopic cholangiograms. We will use ex vivo porcine specimens in a temperature-controlled box trainer model. Specifics such as temperature of infusate and type of infusate will be tested. Next, thermal images will be compared to fluoroscopic images for the detection of choledocholithiasis and bile duct injury. The final set of experiments will examine whether motion detection software augments the surgeons’ ability to detect leaks or stones. These experiments will build on our pilot project and establish whether thermal cholangiography can yield information equivalent to fluoroscopy. Subsequent studies will test thermal cholangiography against fluoroscopic cholangiography in the clinical setting. The ultimate goal of these studies is to provide a simple and effective method for performing intraoperative cholangiography, thereby broadening its use and improving patient outcomes. Background Imaging is critical to the safe and effective conduct of laparoscopic operations. Current imaging technology uses high definition cameras with three charge coupled devices (CCDs). While high definition 3-CCD cameras provide reliable images, there have been few recent advances in laparoscopic imaging capabilities. Surgeons have a need for an imaging technique that augments their capability to delineate anatomy1,2. This is most evident for intraoperative cholangiography. In the United States there are over 750,000 laparoscopic cholecystectomies performed annually. Bile duct injury occurs in 0.4% of those cases3, mainly due to confusion regarding anatomy4,5. Biliary injury can be devastating to patients, surgeons, and the health care system. Patients who suffer bile duct injury require major reconstructive surgery, experience severe morbidity, and have a one-year mortality rate of 6%6. Bile duct injury is a frequent source of litigation against surgeons and hospitals, and the injury costs the United States health care system 1 billion dollars per year in patient care expenses and litigation costs7. By clarifying anatomy, intraoperative cholangiography reduces bile duct injury by 50%8-10, yet is it performed in less than half of laparoscopic cholecystectomies11. There are several barriers to pervasive intraoperative cholangiography12: Standard fluoroscopic cholangiography can be cumbersome, time consuming, and receives low reimbursement. Intraoperative ultrasound is an alternative, but this requires specialized training in image interpretation and has not been widely adopted. Near infrared fluorescence cholangiography is a newer technology, but it requires an expensive device and intravenous injection of a fluorescent agent. Thermal imaging is a solution to expand the use of intraoperative cholangiography during laparoscopic cholecystectomy. Thermal cameras detect differences in temperature to generate an image. Thermal imaging is simple to perform, inexpensive, and can be overlain with standard images to provide surgeons with augmented reality. Although widely used in the military, law enforcement, and environmental sciences, thermal technology has not yet impacted the field of medicine In conjunction with InnoVital Systems, Inc., we have developed a thermal endoscope for laparoscopic surgery. The thermal endoscope uses a commercially available thermal camera which has been modified to use in laparoscopy. The handheld device is controlled by the surgeon and requires no additional personnel to operate. A real-time image is projected onto a monitor for contemporaneous interpretation. We have performed thermal cholangiograms on porcine specimens and the results have been favorable (see figure below). To perform the thermal cholangiogram, we injected cold saline into the gallbladder. The thermal image clearly delineated the anatomy and detected a leak in the biliary tree. In our pilot project, thermal cholangiography was simple to perform and easy to interpret. catheter gallbladder leak Bile duct a b c Figure. (a) Thermal cholangiogram in porcine specimen. Gallbladder and bile duct incompletely filled with cool saline (b) Thermal cholangiogram with complete filling of gallbladder and bile duct clearly demonstrating anatomy (c) Image after puncture of gallbladder clearly showing saline leaking from organ, indicating a breach in the integrity of the wall. Thermal imaging may be a means of increasing use of intraoperative cholangiography, with the attendant improved patient outcomes. It is a simple and inexpensive technology which can augment surgeons’ visualization. Expanding the penetrance of intraoperative cholangiogram will reduce the incidence of bile duct injury, improve outcomes, and reduce health care costs. Hypothesis This study will investigate the capabilities of the thermal endoscope for laparoscopy to image the biliary tree using an ex vivo porcine model. Thermal imaging will be compared to the current gold-standard, fluoroscopy. This study will focus on one hypothesis: Thermal cholangiography is equivalent to fluoroscopic cholangiography for defining biliary anatomy, detecting filling defects, and identifying leaks in the biliary tree. Methods This study will build on the proof-of-principle study we conducted showing the feasibility of thermal cholangiography. The goal of the current study is to optimize the technique of thermal cholangiography and determine its ability to provide clinically relevant information prior to embarking on large animal studies and a clinical trial. Per scientific standards, these laboratory experiments will be completed in quintuplicate to ensure their validity. Post hoc image analysis will be independently performed in triplicate. Power analysis and sample size assessment are not essential for these laboratory experiments. Aim 1: To establish the basic principles of thermal cholangiography using an ex vivo porcine model. Rationale: Thermal imaging in laparoscopy is a novel technology which has not been thoroughly investigated. Establishing the basic principles is therefore needed to advance the technique. The optimal temperature differential between target tissue and infusate, fluid type for infusate, and distance between target tissue and scope will be determined in this aim. Methods: An ex vivo porcine cholangiogram model will be used. Intact porcine biliary trees will be secured in an enclosed laparoscopic box trainer. An air- warming device will maintain the system at a constant 37°. The thermal endoscope for laparoscopy will be used to obtain the images. Establishing optimal temperature differential: Thermal imaging relies on temperature differentials to generate an image. The most distinct image is produced when the temperature variances are large. This may not be practical in the clinical setting when infusing fluids to establish the temperature differential. Excessively cold fluids may induce hypothermia and hot fluids may cause injury. Thermal cholangiograms will be conducted using saline at various temperatures with the goal of determining precisely how much variance between body temperature (37°) and fluid temperature is necessary to generate an adequate image. Five cholangiograms will be performed with each of the following saline temperatures: 10°, 15°, 20°, 22° (room temperature), 25°, 30°, 32°, 34°, 36°, 38°, 40°, 45°, and 50°. The thermal images will be captured and scored post hoc by 3 surgeons using a 5-point Likert scale for the following data points: visualization of gallbladder, visualization of cystic duct, visualization of hepatic ducts, visualization of common bile duct, visualization of duodenal filling. A rating of 5 on the Likert scale will be equivalent to a clear, well-performed fluoroscopic cholangiogram. Such an image will be provided to reviewers to use as a benchmark. Establishing optimal fluid for infusate: One of the long-term goals of thermal imaging is as an imaging method in austere environments. Establishing if simple fluids, such as tap water, are adequate for thermal cholangiography is important for such conditions. In this experiment we will determine whether type of fluid influences quality of the thermal image. The above model will be used with fluid at the optimal temperature, as established above. Five cholangiograms will be performed using each of the following fluids:
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