Confocal laser endomicroscopy in diagnosing indeterminate biliary strictures and pancreatic lesions − a prospective pilot study

2020 ◽  
Vol 99 (6) ◽  
pp. 258-265

Introduction: An accurate histopathological diagnosis of indeterminate biliary strictures and pancreatic lesions is challenging because of insufficient quality of tissue specimen taken during ERCP (brush cytology), cholangioscopy (biopsies) or endosonography (EUS, FNAB). Confocal laser endomicroscopy (CLE) allows virtual histopathological diagnosis with the potential to either replace or increase the diagnostic yield of standard histopathological diagnosis in patients presenting with biliary strictures and pancreatic lesions. The aims of our prospective pilot study were to: 1. Assess the diagnostic yield of standard histopathology compared to CLE in patients referred for cholangioscopy or for EUS of the pancreas; 2. Evaluate the cost of CLE in these indications. Methods: CLE was performed (during cholangioscopy or EUS), followed by standard tissue sampling. CLE-based diagnosis was compared with standard histopathology/cytology. CLE probe was introduced through the working channel of the cholangioscope or through the FNAB needle. Results: A total of 23 patients were enrolled (12 women, mean age 61 years); 13 patients underwent cholangioscopy and 10 patients underwent EUS. Cholangioscopy: CLE diagnosed correctly all 4 malignant strictures (histology 2 of them only as 2 patients had insufficient quality of the tissue specimen). Agreement between standard histopathology and CLE was achieved in 85 %. EUS: All 3 cases of pancreatic cancer were correctly diagnosed by both CLE and FNAB. All remaining (premalignant and benign) lesions were also correctly diagnosed by both methods. The cost of CLE examination is higher compared to FNAB but comparable with tissue sampling during digital cholangioscopy. Conclusion: CLE demonstrated sufficient diagnostic accuracy in patients with indeterminate biliary strictures or pancreatic lesions and, therefore, might improve diagnostic accuracy or even replace standard histopathology in these indications.

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Yuki Tanisaka ◽  
Shomei Ryozawa ◽  
Kouichi Nonaka ◽  
Masami Yasuda ◽  
Akashi Fujita ◽  
...  

Background. The accurate diagnosis of biliary strictures remains problematic. The aim of the present study was to prospectively evaluate the clinical utility of probe-based confocal laser endomicroscopy (pCLE) under the direct view of peroral cholangioscopy (POCS) for the diagnosis of biliary strictures. Methods. Consecutive patients with biliary strictures were included. We investigated sensitivity, specificity, and accuracy to diagnose malignancy for (1) ERCP alone, (2) POCS, (3) pCLE under the direct view of POCS, and (4) tissue sampling under the direct view of POCS. Results. A total of 30 patients (17 with malignant lesions) were prospectively enrolled. (1) ERCP alone showed 88.2% sensitivity, 46.2% specificity, and 70% (95% confidence interval (CI), 52.1%–83.3%) accuracy. (2) POCS showed 100% sensitivity, 76.9% specificity, and 90% (95% CI, 74.4%–96.5%) accuracy. (3) pCLE under the direct view of POCS showed 94.1% sensitivity, 92.3% specificity, and 93.3% (95% CI, 78.7%–98.8%) accuracy. (4) Tissue sampling under the direct view of POCS showed 82.4% sensitivity, 100% specificity, and 90% (95% CI, 74.4%–96.5%) accuracy. Conclusions. pCLE under the direct view of POCS provided highly accurate and sensitive characterization of biliary strictures and showed the potential for more diagnostic reliability and reduction of delays in diagnosis. This trial was registered at UMIN (registration number: UMIN000033801).


2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Michel Kahaleh ◽  
Marc Giovannini ◽  
Priya Jamidar ◽  
S. Ian Gan ◽  
Paola Cesaro ◽  
...  

Background. Accurate diagnosis and clinical management of indeterminate biliary strictures are often a challenge. Tissue confirmation modalities during Endoscopic Retrograde Cholangiopancreatography (ERCP) suffer from low sensitivity and poor diagnostic accuracy. Probe-based confocal laser endomicroscopy (pCLE) has been shown to be sensitive for malignant strictures characterization (98%) but lacks specificity (67%) due to inflammatory conditions inducing false positives.Methods. Six pCLE experts validated the Paris Classification, designed for diagnosing inflammatory biliary strictures, using a set of 40 pCLE sequences obtained during the prospective registry (19 inflammatory, 6 benign, and 15 malignant). The 4 criteria used included (1) multiple thin white bands, (2) dark granular pattern with scales, (3) increased space between scales, and (4) thickened reticular structures. Interobserver agreement was further calculated on a separate set of 18 pCLE sequences.Results. Overall accuracy was 82.5% (n=40retrospectively diagnosed) versus 81% (n=89prospectively collected) for the registry, resulting in a sensitivity of 81.2% (versus 98% for the prospective study) and a specificity of 83.3% (versus 67% for the prospective study). The corresponding interobserver agreement for 18 pCLE clips was fair (k=0.37).Conclusion. Specificity of pCLE using the Paris Classification for the characterization of indeterminate bile duct stricture was increased, without impacting the overall accuracy.


Endoscopy ◽  
2018 ◽  
Vol 51 (06) ◽  
pp. 560-565 ◽  
Author(s):  
Ming-Ming Zhang ◽  
Ning Zhong ◽  
Xiao Wang ◽  
Chang-Qing Li ◽  
Rui Ji ◽  
...  

Abstract Background The diagnostic yield of current techniques for gastric subepithelial tumors (SETs) is suboptimal. This prospective study aimed to develop diagnostic criteria for needle-based confocal laser endomicroscopy (nCLE) of gastric SETs, and to evaluate the diagnostic efficacy, feasibility, and safety of endoscopic ultrasound-guided nCLE (EUS-nCLE). Methods Eligible patients were prospectively recruited to undergo EUS-nCLE. Four unblinded investigators evaluated nCLE videos and corresponding histopathology to develop the nCLE criteria. The recorded nCLE videos were reviewed off-line by one endoscopist 3 months later. Image quality (five-point scale, 1 = poor and 5 = very good) and the interobserver agreements were assessed. Results All 33 patients underwent successful EUS-nCLE procedures. The nCLE criteria for gastric SETs were established. Overall accuracy of off-line nCLE was significantly higher than that of EUS alone (87.9 % vs. 63.6 %; P = 0.02). The mean image quality score was 3.9. The kappa values of the interobserver agreements were 0.66 for gastrointestinal stromal tumor, 0.89 for ectopic pancreas, 0.58 for leiomyoma, and 0.72 for carcinoma. Conclusions EUS-nCLE was feasible and safe to accurately diagnose gastric SETs.


2018 ◽  
Vol 38 (02) ◽  
pp. 160-169 ◽  
Author(s):  
Sumera Rizvi ◽  
John Eaton ◽  
Ju Dong Yang ◽  
Vinay Chandrasekhara ◽  
Gregory Gores

AbstractThe diagnosis of malignant biliary strictures remains problematic, especially in the perihilar region and in primary sclerosing cholangitis (PSC). Conventional cytology obtained during endoscopic retrograde cholangiography (ERC)-guided brushings of biliary strictures is suboptimal due to limited sensitivity, albeit it remains the gold standard with a high specificity. Emerging technologies are being developed and validated to address this pressing unmet patient need. Such technologies include enhanced visualization of the biliary tree by cholangioscopy, intraductal ultrasound, and confocal laser endomicroscopy. Conventional cytology can be aided by employing complementary and advanced cytologic techniques such as fluorescent in situ hybridization (FISH), and this technique should be widely adapted. Interrogation of bile and serum by examining extracellular vesicle number and cargo, and exploiting next-generation sequencing and proteomic technologies, is also being explored. Examination of circulating cell-free deoxyribonucleic acid (cfDNA) for differentially methylated regions is a promising test which is being rigorously validated. The special expertise required for these analyses has to date hampered their validation and adaptation. Herein, we will review these emerging technologies to inform the reader of the progress made and encourage further studies, as well as adaptation of validated approaches.


2019 ◽  
Vol 07 (11) ◽  
pp. E1515-E1521
Author(s):  
Tomomitsu Tahara ◽  
Noriyuki Horiguchi ◽  
Tsuyoshi Terada ◽  
Hyuga Yamada ◽  
Dai Yoshida ◽  
...  

Abstract Background and study aims Endoscopic diagnosis of superficial non-ampullary duodenal epithelial tumors (SNADETs) has not been established. Probe-based confocal laser endomicroscopy (pCLE: Cellvizio) provides real-time endomicroscopic analysis. We developed and validated a new pCLE classification of SNADET based on abnormal findings. Patients and methods pCLE scanning of 20 SNADET lesions including 16 adenomas and four carcinomas was retrospectively evaluated to explore abnormal pCLE findings in relation to histological features. Diagnostic yield of pCLE findings was prospectively evaluated in an additional 20 SNADET lesions including 16 adenomas and four carcinomas. Results In a retrospective study, we identified four abnormal pCLE findings of SNADETs: (1) dark epithelium, (2) columnar cells irregularly extending to the lumen, (3) distorted crypt structure, and (4) fluorescein leakage. Dark epithelium distinguished neoplastic lesions (adenomas and carcinomas) from non-neoplastic duodenal mucosa with a sensitivity of 90 % and a specificity of 100 %. Distorted crypt structure distinguished carcinomas from adenomas and non-neoplastic duodenal mucosa with a sensitivity of 100% and a specificity of 94 %. In the prospective study, the sensitivity and the specificity of the dark epithelium for the diagnosis of neoplastic lesions (adenomas + carcinomas) was 75% and 100 %. Sensitivity and the specificity of the distorted crypt structure for discrimination of carcinoma from adenoma were 100 % and 94 %, respectively. Conclusions The pCLE findings correlated with the histopathology of the SNADETs. Dark epithelium and distorted crypt structure were informative pCLE findings to predict presence of neoplasia and cancer in the SNADET, respectively.UMIN-CTR UMIN000013857 TRIAL REGISTRATION: Single-Center, prospective observational trial UMIN000013857 at upload.umin.ac.jp


2016 ◽  
Vol 150 (4) ◽  
pp. S627
Author(s):  
Alessandro Fugazza ◽  
Federica Gaiani ◽  
Maria Clotilde Carra ◽  
Michaël Levy ◽  
Iradj Sobhani ◽  
...  

2017 ◽  
Vol 27 (2) ◽  
pp. 96-102
Author(s):  
Yung Ka Chin ◽  
Christopher Jen Lok Khor ◽  
Brian Kim Poh Goh ◽  
Tony Kiat Hon Lim ◽  
Damien Meng Yew Tan

Background/aim: Pancreatic cystic lesions are increasingly diagnosed from cross-sectional imaging done for other indications. The challenge lies in the ability to correctly identify the high-risk individuals for resection surgery, which carries high morbidity and mortality. Unfortunately, present diagnostic techniques are suboptimal. Needle-based confocal laser endomicroscopy (nCLE) has been designed to bridge this diagnostic gap. We aim to assess the feasibility and safety of nCLE in the assessment of pancreatic cystic lesions. Methods: We prospectively recruited patients referred for assessment of pancreatic cystic lesions from August 2014 until July 2015. All pancreatic cystic lesions were examined with nCLE miniprobe via endoscopic ultrasound followed by fine-needle aspiration. Information regarding the cysts (morphology, location, fluid analysis etc.) was documented. Adverse event was recorded. Results: Fourteen patients were recruited, six were male with a mean age of 66.5 (range 48–80) years. Only 12 completed nCLE examination of the pancreatic cystic lesions. nCLE imaging was successful in 83.3% (10/12). Average nCLE imaging duration was 5 min 18 s. There was one (10%) adverse event. nCLE impressions were correct in eight cases (five malignant and three benign) compared with final diagnosis. Three patients underwent surgery, histology showed ductal adenocarcinoma, pancreatic neuroendocrine tumor and gastric-subtype of intraductal papillary mucinous neoplasm. The sensitivity and specificity of the nCLE impression when compared with final diagnosis were 83.3% and 75% respectively. The accuracy of nCLE was 80%. Conclusion: Our results have demonstrated that nCLE assessment of pancreatic cystic lesions is safe and feasible. It may complement the existing diagnostic modalities to improve diagnostic yield.


Sign in / Sign up

Export Citation Format

Share Document