Biliary/Pancreas

24 - An International External Interobserver and Derivation Study for the Detection of Advanced Neoplasia in IPMNs Using Confocal Laser Endomicroscopy

Tuesday, October 9
9:20 AM - 9:30 AM
Location: Terrace Ballroom 4 (level 400)

Category: Biliary/Pancreas
Somashekar G. Krishna, MD, MPH1, John M. DeWitt, MD2, Christopher J. DiMaio, MD3, Pradermchai Kongkam, MD4, Bertrand Napoleon, MD5, Mohamed Othman, MD6, Damien Tan, MBBS7, Samer El-dika, MD, MSc1, Sean McCarthy, MD1, Jon Walker, MD1, Mary Dillhoff, MD1, Andrei Manilchuk, MD1, Phil Hart, MD1, Zobeida Cruz-Monserrate, PhD1, Darwin Conwell, MD, MS1
1The Ohio State University Wexner Medical Center, Columbus, OH; 2Indiana University Health Medical Center, Indianapolis, IN; 3Icahn School of Medicine at Mount Sinai, New York, NY; 4King Chulalongkorn Memorial Hospital, Bangkok, Krung Thep, Thailand; 5Hôpital privé Jean Mermoz, Lyon, Auvergne, France; 6Baylor College of Medicine, Houston, TX; 7Singapore General Hospital, Singapore, Singapore

Introduction: Prior studies have validated EUS-guided needle-based confocal laser endomicroscopy (nCLE) diagnosis of IPMNs by detection of characteristic “papillae”. We sought to further assess the performance and interobserver agreement (IOA) of EUS-nCLE for differentiating IPMNs with high grade dysplasia (HGD) or adenocarcinoma (HGD-Ca) from those with low or intermediate-grade dysplasia (LGD).

Methods: In a prospective single center study evaluating EUS-nCLE for the evaluation of pancreatic cysts, 26 patients with a definitive diagnosis of IPMNs (surgery=24; confirmatory cytology/metastatic adenocarcinoma=2) were identified. EUS-nCLE imaging variables predictive (Table 1) of advanced neoplasia were internally derived amongst 3 EUS-MDs with experience in nCLE (Fig. 1).
Six external endosonographers (nCLE experience>30 cases) blinded to all clinical data, reviewed all nCLE videos (Fig. 2). After 2 weeks, the assessors reviewed the same images in a different sequence. A self-study tutorial of nCLE variables predictive of HGD-Ca was provided before each review. Prior to the second review, an interactive web-based discussion was also conducted. The IOAs (κ statistic) of diagnostic nCLE image patterns to detect HGD-Ca were calculated.

Results: Among the subjects with IPMNs (16 mixed, 10 branch-duct; mean size 3.4±1.7 cm), there were 9 with LGD and 17 with advanced neoplasia (12 HGD, 2 non-invasive and 3 invasive adenocarcinoma). The six observers identified papillary structures diagnostic of IPMN in all videos. The overall sensitivity, specificity, accuracy, and IOA of EUS-nCLE to diagnose HGD-Ca was 90%, 73%, 84%, and κ=0.54 (moderate), respectively (Table 1).

Correlating with histopathological progression of dysplasia in IPMNs, nCLE imaging characteristics of papillary “thickness” (indicative of cellular and nuclear stratification) and “darkness” (increased nuclear/cytoplasmic ratio) were the most sensitive (90% and 91%) and accurate (86% and 84%) with substantial (κ=0.61) and moderate (κ=0.55) IOAs for detecting HGD-Ca, respectively (Table 1).

Discussion: In this derivation study, blinded expert endosonographers identified several EUS-nCLE imaging features of IPMNs that are associated with advanced neoplasia. Further studies are needed to refine and validate these features for applying EUS-nCLE to identify advanced dysplasia.

Figure 1. EUS-guided needle based confocal endomicroscopy imaging features in differentiating degree of dysplasia in IPMNs
Table 1. EUS-guided needle based confocal endomicroscopy imaging variables predictive of advanced neoplasia: diagnostic parameters and interobserver agreement. CI: Confidence Interval.
Figure 2. Study design

Disclosures:
Somashekar Krishna indicated no relevant financial relationships.
John DeWitt indicated no relevant financial relationships.
Christopher DiMaio: Boston Scientific – Consultant, Speaker's Bureau. Medtronic – Consultant, Speaker's Bureau.
Pradermchai Kongkam indicated no relevant financial relationships.
Bertrand Napoleon: mauna kea technology – fees for teaching workshops.
Mohamed Othman indicated no relevant financial relationships.
Damien Tan indicated no relevant financial relationships.
Samer El-dika indicated no relevant financial relationships.
Sean McCarthy indicated no relevant financial relationships.
Jon Walker indicated no relevant financial relationships.
Mary Dillhoff indicated no relevant financial relationships.
Andrei Manilchuk indicated no relevant financial relationships.
Phil Hart indicated no relevant financial relationships.
Zobeida Cruz-Monserrate indicated no relevant financial relationships.
Darwin Conwell indicated no relevant financial relationships.

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24 - An International External Interobserver and Derivation Study for the Detection of Advanced Neoplasia in IPMNs Using Confocal Laser Endomicroscopy



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