The Pancreatic Cyst Dilemma
More and more patients are being diagnosed with pancreatic cysts but <1% per year will be malignant.2,3
Balancing the morbidities and mortalities associated with surgical removal of cysts with the high mortality rate of pancreatic cancer can be challenging. Understanding of the risk of malignancy for a cyst can help with decisions as to whether or not surgery is the best option for patients.
Studies have shown that up to 80% of surgeries reveal indolent cysts that didn’t necessarily require surgery.5,6
What if we could help you better predict whether a cyst will remain indolent or become malignant, providing useful information for your surveillance and surgery strategies?
Webinar: Optimizing Endoscopic Ultrasound and Pancreatic Cyst Fluid Analysis for your Patient
- Approach to Cyst Evaluation
- Clinical Guidelines: Worrisome Features
- Incorporating EUS and Molecular Cyst Fluid Analysis
Current Testing Methods
- Today’s standard of care examines risk factors for malignancy based on the patient’s clinical history and the cyst’s image (MRI, CT, EUS), cells (cytology), and fluid proteins (chemistry).
- These approaches provide some information into the properties of a cyst, but do not provide insights into what is occuring in the DNA, where cancer begins.
- Assessing the risk of malignancy using these approaches can be difficult, given their limited insights into cyst biological behavior.
Based on the National Pancreatic Cyst Registry, the following highlights the limitations of current testing modalities1:
| Benign | Malignant | |
|---|---|---|
| <1 cm | 41 | 2 |
| 1-2 cm | 168 | 14 |
| 2-3 cm | 86 | 10 |
| >3 cm | 77 | 22 |
- Cysts that are small (< 3cm) can be malignant.
- Cysts that are large (> 3cm) can be benign.
- Most cysts with a solid component are actually benign (n= 42/66).
- Cysts lacking a solid component can be malignant.
| CEA Level | Benign | Malignant |
|---|---|---|
| 0-5 ng/mL | 49 | 4 |
| 5-192 ng/mL | 85 | 7 |
| 192-1000 ng/mL | 71 | 9 |
| >1000 ng/mL | 55 | 21 |
- Nearly one-third of patients with a malignant cyst have a CEA level lower than 192 ng/ml.
- Most cysts with a high CEA level (>192ng/mL) are actually benign.
- The presence of malignant or suspicious cells in cyst fluid are good indicators of maligancy.
- Often there are too few cells to distinguish between benign and maligant disease based on cellular atypia.
- Malignancy can be present in specimens that lack cells with atypia.
- The presence of a KRAS mutation is not indicative of malignancy.
- Most cysts with a KRAS mutation present are benign at ~3 years follow-up (83.5%; 142/170).
- Some cysts lacking KRAS mutation were malignant (12.0%; 37/300)
The Solution
PancraGEN is an integrated molecular pathology test that provides powerful insight into the cumulative DNA mutations present in your patient’s pancreatic cyst. Used in conjunction with chemistry, cytology, and imaging, PancraGEN provides a tailored, DNA-based risk assessment for cancer in each patient, helping you to improve long-term management strategies.
Limitations and Disclaimers1
Although PancraGEN is highly specific for malignancy, some malignant cysts may not be detected. There may also be individuals who are falsely identified as having a malignant cyst. Diagnosis and appropriate patient management are the responsibility of the referring physician or healthcare provider.
References
- Al-Haddad MA, Kowalski T, Siddiqui A, et al. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. 2015;47(2):136-146.
- V. Chernyak et al, Incidental pancreatic cystic lesions Radiology 2015 274 161-9
- BU Wu, et al, Prediction of malignancy in cystic neoplasms of the pancreas: a population based cohort study, Am J Gastro 2014 109 121-9
- Loren D, Kowalski T, Siddiqui A, et al. Influence of integrated molecular pathology test results on real-world management decisions for patients with pancreatic cysts: analysis of data from a national registry cohort. Diagnostic Pathology. 2016;11:5. doi:10.1186/s13000-016-0462-x.
- Gaujoux S., , Brennan, M., et al. Cystic Lesions of the Pancreas: Changes in the Presentation and Management of 1,424 Patients at a Single Institution over a 15-year Time Period. J Am Coll Surg. 2011 April; 212(4): doi:10.1016/j.jamcollsurg.2011.01.016.
- Kaimalkliotis, P., Riff, B., et al. Sendai and Fukuoka Consensus Guidelines Identify Advanced Neoplasia in Patients With Suspected Mucinous Cystic Neoplasms of the Pancreas. Clinical Gastroenterology and Hepatology 2015;13:1808–1815: doi:10.1016/j.cgh.2015.03.017
- Kushnir VM, Mullady DK, Das K, et al. J Clin Gastroenterol. 2019;53(9):686-692. DOI: 10.1097/MCG.0000000000001118.
- Gonda TA, Viterbo D, Gausman V, et al. Clin Gastroenterol Hepatol. 2017;15:913-919.
- Data on File.