Pancreatic Cysts
Cellvizio® is the real-time in vivo cellular imaging platform that significantly improves the classification and risk-stratification of indeterminate cysts quickly and with greater certainty.
Why are indeterminate pancreatic cysts far too common?
Pancreatic cancer remains difficult to diagnose accurately using conventional methods often leading to late-stage diagnoses or unnecessary surgeries.1
Cellvizio® is the real-time in vivo cellular imaging platform that significantly improves the classification and risk-stratification of indeterminate cysts quickly and with more certainty.
Up to 30% of cases remain indeterminate after endoscopic ultrasonography (EUS)…2
…and over 50% of cysts are inconclusive after fine-needle aspiration (FNA).3
With current guideline-based management and clinical practice, 40–78% of surgeries are performed unnecessarily on benign or low-grade dysplasia lesion patients due to uncertain diagnoses.1, 4
There is a clear need for more accurate classification methods, including risk stratification, earlier in the patient’s diagnostic workup.
Cellvizio® improves diagnostic accuracy, enabling you to confidently manage patients and reduce surgical intervention.
Cellvizio® Clinical Value
Is this cyst an indeterminate mucinous lesion or a benign SCA (serous cystadenoma)? You need a definitive diagnosis.
Needle-based Confocal Laser Endomicroscopy (nCLE) with Cellvizio® allows you to see the cyst wall at the microscopic level through a high-speed flexible microscope threaded inside a 19-gauge needle during EUS-FNA procedures (EUS-nCLE). This improves accuracy for the diagnosis of mucinous PCLs to 97% with nCLE alone5, compared to alternative tests, as seen in the table below.6
See one patient case of nCLE in Pancreatic Cyst Assessment with Dr. Bertrand Napoléon, a gastroenterologist and interventional endoscopist.
Diagnostic Classification of Mucinous vs. Non-Mucinous PCLs Compared with Definitive Histopathology
Similar results are shown in a meta-analysis comprising 3,641 patients with cysts, concluding that adding Cellvizio® to an EUS procedure was superior for the diagnosis of pancreatic cysts, for centers with relevant expertise.7
“My approach to evaluating pancreatic cystic lesions is revolutionized, creating a major change in patient management.”
Dr. C. J. DiMaio
St. Francis Hospital & Heart Center
Patient Management
Alleviating patient anxiety by having a definitive diagnosis after EUS-FNA
Cellvizio’s high sensitivity and accuracy would translate to a marked reduction in late-stage diagnoses of advanced pancreatic cancer and unnecessary surgeries on benign or low-grade lesions, totaling as many as 2,000 unnecessary surgeries per year in the United States.1
Economic Benefit
Accurate diagnosis has proven economic benefits for facilities
In addition to the proven clinical and patient management benefits, Cellvizio also offers downstream revenue opportunities by accurate upstaging and downstaging of PCLs. One cost-benefit analysis study showed significant cost savings in the management of PCLs (≥ 3 cm) by preventing at least one unnecessary pancreatic surgery for every ten subjects undergoing evaluation by current practices.11
Overall, the addition of nCLE led to a fully burdened net savings of $442,438 (mean: $4,757.40/patient) for this cohort.11
Learn more about the cost-benefit analysis here.
Characterization of Cyst using Cellvizio®
AQ-Flex™ 19 Miniprobe
Characterization of Cyst
using Cellvizio® AQ-Flex™
19 Miniprobe
Non-Mucinous – Serous cystadenoma
Criteria: superficial vascular networking
Mucinous IPMN
Criteria: papillary projection
Mucinous cystadenoma
Criteria: epithelial border
References & disclaimers
- Sharib, Jeremy et al. Cost-effectiveness of consensus guideline based management of pancreatic cysts: The sensitivity and specificity required for guidelines to be cost-effective. Surgery, 2020. Volume 168, Issue 4, 601 – 609.
- Rodríguez-D’Jesús A, et al. Impact of endoscopic ultrasonography (EUS) and EUS-guided fine-needle aspiration on the management of pancreatic cystic lesions. Eur J Gastroenterol Hepatol, 2016.
- Thornton GD. et al. Endoscopic ultrasound guided fine needle aspiration for the diagnosis of pancreatic cystic neoplasms: a meta-analysis. Pancreatology, 2013.
- Marchegiani G, et al. Progression vs Cyst Stability of Branch-Duct Intraductal Papillary Mucinous Neoplasms After Observation and Surgery. JAMA Surg. 2021;156(7):654–661. doi:10.1001/jamasurg.2021.1802.
- Krishna SG, et al. Endoscopic Ultrasound-Guided Confocal Laser Endomicroscopy Increases Accuracy of Differentiation of Pancreatic Cystic Lesions. Clinical Gastroenterology and Hepatology, 2019.
- Burlen, Jordan et al. 1081 Accuracy of Real-time Eus-guided Confocal Laser Endomicroscopy Interpretation for Discerning Specific Types of Pancreatic Cystic Lesions: Insights From a Multicenter Prospective Study. Gastroenterology, 2024. Volume 166, Issue 5, S-256 – S-257.
- Li SY, et al. Comparative Performance of Endoscopic Ultrasound-Based Techniques in Patients With Pancreatic Cystic Lesions: A Network Meta- Analysis. The American Journal of Gastroenterology, 2023.
- Napoléon B, et al. Confocal endomicroscopy for evaluation of pancreatic cystic lesions: a systematic review and international Delphi consensus report. Endosc Int Open, 2020.
- Palazzo et al. Impact of needle-based confocal laser endomicroscopy on the therapeutic management of single pancreatic cystic lesions, Surgical Endoscopy, 2019.
- Le Pen C et al. A health economic evaluation of needle-based Confocal Laser Endomicroscopy for the diagnosis of pancreatic cysts. Endoscopy International Open (2017).
- Luthra A, et al. Cost-Benefit Analysis and Resource Implications of Endoscopy Ultrasound-guided Confocal Endomicroscopy in Pancreas Cysts, Techniques and Innovations in Gastrointestinal Endoscopy, 2021. https://doi.org/10.1016/j.tige.2021.10.002.
Cellvizio® I.V.E. with Confocal MiniprobesTM are regulated Medical Devices, CE marked (CE 0459) (Class IIa – NB : G-MED) and FDA cleared. Cellvizio® is a registered trademark and Confocal MiniprobeTM is a trademark of Mauna Kea Technologies. Cellvizio® I.V.E. with Confocal MiniprobesTM is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. FDA clearance: indications for use: Once connected to the Cellvizio® I.V.E: The AQ-FlexTM 19 Confocal MiniprobesTM are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles). CE marked: indications for use: Once connected to the Cellvizio® I.V.E: The AQ-FlexTM 19 Confocal MiniprobesTM are intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts and respiratory tracts accessed by an endoscope or endoscopic accessories, including through endoscopic needles. Please consult labels and instructions for use. These statements and the associated reference to specific clinical studies, are not intended to represent claims of safety or effectiveness for detecting or treating any specific condition or disease state. Rather this information is intended to provide useful reference to selected published literature describing physician experiences with the associated clinical uses. Any diagnostic assessment should always be made by the attending physician, based on the evaluation of all sources of clinical, endoscopic and other relevant information. These statements have not been reviewed, cleared, or approved by the U.S. FDA. The use of this medical device is exclusively reserved for health professionals. Product availability cannot be guaranteed in all countries. For further information, please contact your local sales representative.
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