Healthcare professionals

The resolution of Cellvizio depends on the type of confocal miniprobe used. The lateral resolution of a GastroFlex™ or ColoFlex™ standard probe is 3.5 microns and 1 micron for a GastroFlex or ColoFlex type ultra-high definition (UHD) probe. The lateral resolution of a CholangioFlex™ probe is 3.5 microns.Endomicroscopy systems image the mucosal tissue with a magnification of about 1000 (using a GastroFlex or ColoFlex type UHD probe), which compares to a magnification of about 400 for high definition zoom endoscopy.

probe-based Confocal Laser Endomicroscopy (pCLE) provides in vivo dynamic observation of the mucosal tissue at the microscopic level, enabling cellular visualization. pCLE provides images in an "en-face" plane, whereas standard histopathology cuts are transverse to the tissue orientation. Moreover, pCLE provides "live" information, including vascular and cellular information, as opposed to standard histology, which is based on still images of fixed cuts of tissue, which may include artifacts from biopsy staining and fixation. pCLE represents the tissue in its natural environment and enables the observation of physiological and pathophysiological processes.

Image interpretation is based on a small number of key features to be recognized in a pCLE video sequence. These key features might or might not be indicative of abnormalities. Most often, they relate to the general pattern observed on the images, and not to individual cells or structures identified in the image. In a sense, it is very similar to endoscopic image interpretation, where the physician is looking for a few landmarks in order to make an educated guess about the nature of the tissue and subsequent patient management (biopsy, endoscopic treatment, etc). Dozens of physicians have been trained on pCLE image interpretation and the vast majority can perform very well after about 20 pCLE cases in a specific indication. This short learning curve has been extensively studied and published. Training workshops are available on a monthly basis to learn or perfect your skills in pCLE. Alternatively, you can use the training resources on Cellvizio.net in order to learn how to interpret images through dedicated tutorials, and test your performance through interactive quizzes. This way, you can monitor your progression and get instant feedback and objective scores on the reliability of your interpretation.

Cellvizio is seamlessly integrated into your endoscopy practice, even more with Cellvizio 100 series (link to product page) which was developed with a special attention to making it easy to use and intuitive. Upon installation of a pCLE system, a full training session is provided by qualified company staff. This training includes an in-service presentation with the physicians, nurses and technicians in your unit, as well as procedural support and a complete image interpretation tutorial. This should make you much more comfortable in handling the device. Once you start using the pCLE system, it is estimated that 10 to 20 procedures is the necessary learning curve in order to master the manipulation and positioning of the probe on the tissue. As the Confocal Miniprobes™ were designed to be used as a standard endoscopic accessory, such as a biopsy forceps or coagulation catheter, you should find it easy to handle the probe during the endoscopic procedure. Again, attending one of the training workshops at a pCLE center of excellence can help you shorten the learning curve for manipulating the system.

As mentioned above, pCLE imaging and pCLE image interpretation is quite different from standard histopathology. As a consequence, a pathologist might not be familiar with pCLE video sequences and with the type of information provided by pCLE imaging. However, some of the landmarks and features you will be looking for are common between pCLE and standard histopathology. Although you might not need a pathologist to learn and master pCLE image interpretation, you might want to involve your dedicated GI pathologist in your pCLE procedures, if he/she expressed interest for this new field. Indeed, using pCLE might help you, as an endoscopist, get additional information useful for patient communication and management, and complementary to the information provided by the pathologist through physical tissue biopsy interpretation. A collaborative approach might be the best way to integrate pCLE into your practice and to enhance patient management.

No.  By nature, the Cellvizio pCLE system is compatible with any endoscope, therefore you will not need a specific endoscope to use the Confocal Miniprobes. Some procedures might be optimized with specific yet standard endoscopic accessories. For instance, the use of a cap might help you better stabilize the Miniprobe on the tissue and get better pCLE images in luminal procedures. During ERCP procedures, the delivery of the Miniprobe is safer and more efficient through a standard ERCP catheter.

It is possible to record the pCLE images and video sequences directly during the procedure. This is performed on the Cellvizio system through the use of a foot pedal, trackball or keyboard, easily accessible during the procedure, or through a connection to the standard recording system in the endoscopy suite. On the Cellvizio system, the video sequences are recorded  in a proprietary format and can be easily exported in any standard video format. Snapshot images can also be exported during the procedure. The recorded images can be used for inclusion in the patient's medical record as well as for training or scientific communication purposes.

pCLE imaging provides additional information about the nature of the mucosa in real time during the endoscopic procedure, and can be applied to virtually any endoscopic procedure. However, as of today, consensus discussions and research efforts have led to a more specific positioning of pCLE for a few indications in gastroenterology: Barrett's esophagus (BE) surveillance and treatment, characterization of indeterminate bilio-pancreatic strictures, and post-EMR follow-up procedures in the colon. Most pCLE users and publications are focused on these main indications and patient populations.

The intended use of the pCLE system as of today is the microscopic observation of the tissue accessed by the endoscope, in real time , thus providing additional information to the physician. The physician is provided with microscopic visualization of the mucosal tissues, which goes beyond what he/she can see with standard or enhanced endoscopic methods.

Based on the decision of the physician, the additional information provided by pCLE during the endoscopic procedure might be used by the physician to document findings of benignity or malignancy, but also to target physical biopsies to suspicious areas only, or to orient patient management, for instance through guidance of endoscopic therapeutic procedures or referral to surgical treatment.

There are many publications on the use of virtual chromoendoscopy for Barrett's Esophagus or ulcerative colitis surveillance, showing different results pertaining to lesion detection or characterization. To date, multicentric clinical studies using pCLE have shown that pCLE is the most accurate modality for characterization of tissue during endoscopy in Barrrett's Esophagus. It improves the detection of BE dysplastic lesions compared to standard and enhanced endoscopy techniques such as NBI.  In any case, as NBI and pCLE are two different imaging techniques providing different levels of magnification and different types of information, they can also be combined to complement each other and provide a complete armamentarium to the physician and optimize patient management.

Deciding to orient the patient management based on pCLE imaging during an endoscopic procedure remains solely the decision of the physician in charge of the patient. The intended use of the pCLE system as of today is the microscopic observation of the tissue accessed by the endoscope, in real-time, thus providing additional information to the physician.Many pCLE users have used pCLE to guide their endoscopic therapeutic procedures, by assessing the margins of resection before, during and after a procedure, or by using pCLE to decide which therapeutic method should be used, or to perform follow-up and re-treat in a single endoscopic session if need be. In a sense, this is already current practice in endoscopy, since physicians often orient patient management based on the endoscopic images alone, while still taking tissue biopsy samples for malignancy documentation. pCLE provides additional information at the microscopic level.

Sending a patient to surgery if pCLE is indicative of malignancy although tissue sampling is negative or indeterminate remains solely the decision of the physician in charge of the patient. The intended use of the pCLE system as of today is the microscopic observation of the tissue accessed by the endoscope, in real-time, thus providing additional information to the physician. Many pCLE users have decided to send patients to surgery after ERCP cases with indeterminate strictures on which pCLE revealed features indicative of malignancy, while tissue sampling methods came back as negative or indeterminate. Many such cases have been documented that the patient indeed had cancer, as confirmed by the surgical specimen.