A prospective trial of CONfocal endomicroscopy in CYSTic lesions of the pancreas: CONCYST-01

Abstract

Background and study aims Pancreatic cystic lesions (PCL) are common. While some harbor malignant potential, accurate preoperative diagnosis remains challenging. Needle-based confocal laser endomicroscopy (nCLE) via a 19G FNA needle enables real-time imaging of the cyst wall. This study evaluated the safety and utility of nCLE in patients with an indeterminate PCL undergoing EUS-FNA.

Patients and methods The CONCYST study prospectively recruited patients with indeterminate PCL attending three hepatopancreaticobiliary (HPB) referral centers in the UK, with indeterminate PCL, who required EUS-FNA between July 2014 and October 2016. Following the procedure, all patients were followed up in telephone clinic for at least 12 months. Ethical approval for the study was granted by the National Research Ethics Service (14/LO/0040).

Results Sixty-seven patient were recruited, 11 excluded and 56 included in the final analysis: 35 male, 21 female; median age 68 (range 28 – 80). Recognizable confocal images were obtained in 48 of 56 cases. Median nCLE scanning time was 5 minutes and did not exceed 10 minutes in any case. EUS-nCLE findings correlated with final diagnosis (based on imaging, cytology and multidisciplinary team review) in 43/56 (77 %) of cases, compared with 37/56 (66 %) for cytology alone (P = 0.12). One patient experienced mild pruritus following the procedure and another developed an infected pseudocyst, which resolved with antibiotics.

Conclusions EUS-nCLE under conscious sedation in the day case setting is safe and provides additional information to standard EUS-FNA for diagnosing indeterminate PCL.

• References

• 1 Laffan TA, Horton KM, Klein AP. et al. Prevalence of unsuspected pancreatic cysts on MDCT. Am J Roentgenol 2008; 191: 802-807
• 2 Spinelli KS, Fromwiller TE, Daniel RA. et al. Cystic pancreatic neoplasms: observe or operate. Annals Surgery 2004; 239: 651-657 discussion 657 – 659
• 3 Ahn JY, Seo DW, Eum J. et al. Single-Step EUS-guided transmural drainage of pancreatic pseudocysts: analysis of technical feasibility, efficacy, and safety. Gut Liver 2010; 4: 524-529
• 4 Adsay NV, Fukushima N, Furukawa T. et al. Intraductal neoplasm of the pancreas. In: Bosman FT, Carneiro F, Hruban RH, Theise ND. WHO classification of tumors of digestive system. Lyon: WHO Press; 2010
• 5 Tanaka M, Fernandez-del Castillo C, Adsay V. et al. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology 2012; 12: 183-197
• 6 Khashab MA, Shin EJ, Amateau S. et al. Tumor size and location correlate with behavior of pancreatic serous cystic neoplasms. Am J Gastroenterol 2011; 106: 1521-1526
• 7 Aad G, Abajyan T, Abbott B. et al. Search for magnetic monopoles in sqrt[s]=7 TeV pp collisions with the ATLAS detector. Phy Review Letters 2012; 109: 261803
• 8 European Study Group on Cystic Tumours of the Pancreas. European evidence-based guidelines on pancreatic cystic neoplasms. Gut 2018; 67: 789-804
• 9 Napoleon B, Lemaistre AI, Pujol B. et al. A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy. Endoscopy 2015; 47: 26-32
• 10 Jais B, Rebours V, Malleo G. et al. Serous cystic neoplasm of the pancreas: a multinational study of 2622 patients under the auspices of the International Association of Pancreatology and European Pancreatic Club (European Study Group on Cystic Tumors of the Pancreas). Gut 2016; 65: 305-312
• 11 Nakai Y, Iwashita T, Park do H. et al. Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study. Gastrointestinal endoscopy 2015; 81: 1204-1214
• 12 Kamboj AK, Dewitt JM, Modi RM. et al. Confocal Endomicroscopy Characteristics of Different Intraductal Papillary Mucinous Neoplasm Subtypes. J Pancreas 2017; 18: 198-202
• 13 Napoleon B, Palazzo M, Lemaistre AI. et al. Needle-based confocal laser endomicroscopy of pancreatic cystic lesions: a prospective multicenter validation study in patients with definite diagnosis. Endoscopy 2018; DOI: 10.1055/a-0732-5356.
• 14 Krishna SG, Brugge WR, Dewitt JM. et al. Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos). Gastrointestinal endoscopy 2017; 86: 644-654.e642
• 15 Khan I, Kumar N, Pant I. et al. Activation of TGF-beta pathway by areca nut constituents: a possible cause of oral submucous fibrosis. PloS one 2012; 7: e51806
• 16 de Jong K, Poley JW, van Hooft JE. et al. Endoscopic ultrasound-guided fine-needle aspiration of pancreatic cystic lesions provides inadequate material for cytology and laboratory analysis: initial results from a prospective study. Endoscopy 2011; 43: 585-590
• 17 Konda VJ, Aslanian HR, Wallace MB. et al. First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos). Gastrointestinal endoscopy 2011; 74: 1049-1060