Observational Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Feb 16, 2021; 13(2): 56-71
Published online Feb 16, 2021. doi: 10.4253/wjge.v13.i2.56
Molecular analysis of pancreatic cystic neoplasm in routine clinical practice
Raquel Herranz Pérez, Felipe de la Morena López, Pedro L Majano Rodríguez, Francisca Molina Jiménez, Lorena Vega Piris, Cecilio Santander Vaquero
Raquel Herranz Pérez, Felipe de la Morena López, Department of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid 28006, Spain
Pedro L Majano Rodríguez, Francisca Molina Jiménez, Molecular Biology Laboratory, Department of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid 28006, Spain
Lorena Vega Piris, Methodological Support Unit, Department of Statistical Analysis, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, CP Madrid, Madrid 28006, Spain
Cecilio Santander Vaquero, Department of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Madrid 28006, Spain
Author contributions: Herranz Pérez R designed the protocol and drafted the manuscript; de la Morena López F helped in the design of the protocol and performed the endoscopic ultrasounds; Majano Rodríguez PL and Molina Jiménez F carried out the molecular analysis and participated in the assessment of the statistical analysis; Vega Piris L performed the statistical analysis; Santander Vaquero C carried out major review changes; all authors reviewed and approved the final manuscript submitted.
Supported by FIB Hospital Universitario de La Princesa, No. G-83727081.
Institutional review board statement: This study was reviewed and approved by the Research Ethics Committee of the Hospital Universitario de La Princesa. The study was registered on Clinical trials: NCT03740360.
Informed consent statement: Informed consent was obtained from all patients prior to study inclusion.
Conflict-of-interest statement: Raquel Herranz Pérez has received research funding from Boston Scientific for investigational purposes only. All other authors have nothing to disclose.
Data sharing statement: Authors grant BPG the license to publish the article and identify itself as the original publisher. No additional data are available.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Raquel Herranz Pérez, MD, Doctor, Department of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, C/Diego de Leon nº62, Madrid 28006, Spain. raquelherranzperez@gmail.com
Received: September 25, 2020
Peer-review started: September 25, 2020
First decision: December 11, 2020
Revised: December 22, 2020
Accepted: January 8, 2021
Article in press: January 8, 2021
Published online: February 16, 2021
Processing time: 130 Days and 19.4 Hours
Abstract
BACKGROUND

Cystic pancreatic lesions consist of a wide variety of lesions that are becoming increasingly diagnosed with the growing use of imaging techniques. Of these, mucinous cysts are especially relevant due to their risk of malignancy. However, morphological findings are often suboptimal for their differentiation. Endoscopic ultrasound fine-needle aspiration (EUS-FNA) with molecular analysis has been suggested to improve the diagnosis of pancreatic cysts.

AIM

To determine the impact of molecular analysis on the detection of mucinous cysts and malignancy.

METHODS

An 18-month prospective observational study of consecutive patients with pancreatic cystic lesions and an indication for EUS-FNA following European clinical practice guidelines was conducted. These cysts included those > 15 mm with unclear diagnosis, and a change in follow-up or with concerning features in which results might change clinical management. EUS-FNA with cytological, biochemical and glucose and molecular analyses with next-generation sequencing were performed in 36 pancreatic cysts. The cysts were classified as mucinous and non-mucinous by the combination of morphological, cytological and biochemical analyses when surgery was not performed. Malignancy was defined as cytology positive for malignancy, high-grade dysplasia or invasive carcinoma on surgical specimen, clinical or morphological progression, metastasis or death related to neoplastic complications during the 6-mo follow-up period. Next-generation sequencing results were compared for cyst type and malignancy.

RESULTS

Of the 36 lesions included, 28 (82.4%) were classified as mucinous and 6 (17.6%) as non-mucinous. Furthermore, 5 (13.9%) lesions were classified as malignant. The amount of deoxyribonucleic acid obtained was sufficient for molecular analysis in 25 (69.4%) pancreatic cysts. The amount of intracystic deoxyribonucleic acid was not statistically related to the cyst fluid volume obtained from the lesions. Analysis of KRAS and/or GNAS showed 83.33% [95% confidence interval (CI): 63.34-100] sensitivity, 60% (95%CI: 7.06-100) specificity, 88.24% (95%CI: 69.98-100) positive predictive value and 50% (95%CI: 1.66-98.34) negative predictive value (P = 0.086) for the diagnosis of mucinous cystic lesions. Mutations in KRAS and GNAS were found in 2/5 (40%) of the lesions classified as non-mucinous, thus recategorizing those lesions as mucinous neoplasms, which would have led to a modification of the follow-up plan in 8% of the cysts in which molecular analysis was successfully performed. All 4 (100%) malignant cysts in which molecular analysis could be performed had mutations in KRAS and/or GNAS, although they were not related to malignancy (P > 0.05). None of the other mutations analyzed could detect mucinous or malignant cysts with statistical significance (P > 0.05).

CONCLUSION

Molecular analysis can improve the classification of pancreatic cysts as mucinous or non-mucinous. Mutations were not able to detect malignant lesions.

Keywords: Pancreatic cysts; Molecular analysis; Next-generation sequencing; Mucinous cyst; Pancreatic cyst fluid; Pancreatic cancer

Core Tip: Pancreatic cystic lesions are frequently found on imaging studies performed for other reasons, but differentiation between the different types and the detection of malignancy is often suboptimal with morphological features. Molecular analysis has been proposed to optimize cyst classification and the detection of malignancy. However, there is little evidence of its feasibility and usefulness in daily practice. The aim of this study was to evaluate the diagnostic yield of molecular analysis for the detection of mucinous and malignant cysts in routine clinical practice.