Table 2.
Summary of the studies applying CLE for gastric and duodenal lesion screening and diagnosis (“per biopsy” analysis or “per patient” analysis).
| Author and year | Country | N | Mean age or range | Sensitivity (%) | Specificity (%) | PPV (%) | NPV (%) | Accuracy (%) | Main findings |
|---|---|---|---|---|---|---|---|---|---|
| Polyps and neoplastic lesions of the stomach | |||||||||
| Kakeji et al. 2006 [37] | Japan | 9 patients | n/a | n/a | n/a | n/a | n/a | n/a | CLE could be a new screening tool for early detection of malignancy. |
| Kitabatake et al. 2006 [38] | Japan | 27 patients | 70 | 81.8 | 97.6 | n/a | n/a | 97.4 | CLE may allow virtual biopsy in the future with more stable imaging condition. |
| Liu et al. 2008 [39] | China | 24 patients | n/a | n/a | n/a | n/a | n/a | n/a | CLE observations of vascular architecture may be assistant in the identification of early gastroesophageal cancer. |
| Gheorghe et al. 2009 [40] | Romania | 11 patients | 59.7 | n/a | n/a | n/a | n/a | n/a | CLE and endoscopic ultrasound are successfully associated for histological assessment, disease staging, and optimal therapeutic decision. |
| Banno et al. 2010 [41] | Japan | 29 patients | 68.6 | 86.4 | 83.3 | n/a | n/a | 85 | The CLE diagnosis of the mucin phenotype in gastric cancers was limited to intestinal and mixed phenotypes but may be useful for the diagnosis of mucin phenotype and differential diagnosis. |
| Li et al. 2010 [42] | China | 66 patients | 17–81 | n/a | n/a | n/a | n/a | 90 | CLE demonstrates high accuracy of differentiating hyperplastic polyps and adenomas. |
| Li et al. 2010 [43] | China | 108 patients | 57 | 77.8 | 81.8 | n/a | n/a | n/a | CLE is an acceptable and potentially useful technology for the identification and grading of gastric intraepithelial neoplasia in vivo. The diagnostic accuracy needs to be improved. |
| Jeon et al. 2011 [44] | Korea | 31 patients | 61.6 | n/a | n/a | n/a | n/a | 94.2 | CLE demonstrates a high diagnostic accuracy for gastric epithelial neoplasia. The use of CLE could possibly reduce the number of unnecessary biopsies and mistaken diagnoses before endoscopic submucosal dissection. |
| Ji et al. 2011 [45] | China | 24 patients | 61.2 | 100 | 89.5 | n/a | n/a | 91.7 | CEL has high accuracy for prediction of remnant tissue after endoscopic mucosal resection and may lead to significant improvements in clinical surveillance after endoscopic resection. |
| Li et al. 2011 [46] | China | 1572 patients | 58.1 | 88.9 | 99.3 | 85.3 | 99.5 | 98.8 | CLE can be used to identify gastric superficial cancer/HGIN lesions with high validity and reliability. |
| Lim et al. 2011 [47] | China | 36 patients | >50 | 95.2 | 93.3 | n/a | n/a | n/a | Experience in CLE was associated with greater accuracy in the diagnosis of gastric intestinal metaplasia. |
| Wang et al. 2012 [48] | China | 59 patients | 63.1 | 90.6 | 84.6 | n/a | n/a | 88 | CLE demonstrates high diagnostic accuracy, sensitivity, and specificity for diagnostic classification of gastric intraepithelial neoplasia. |
| Bok et al. 2013 [49] | Korea | 46 patients | 65.3 | n/a | n/a | n/a | n/a | 91.7 | pCLE can provide an accurate diagnosis for superficial gastric neoplasia, and it has the potential to compensate for the inherent limitations of a conventional endoscopic biopsy. |
|
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| Gastritis and gastric metaplasia | |||||||||
| Guo et al. 2008 [50] | China | 53 patients 267 biopsies |
51.2 | n/a 98.1 |
n/a 95.3 |
n/a 96.9 |
n/a 97.14 |
n/a n/a |
CLE is a useful and potentially important method for the diagnosis and classification of gastric intestinal metaplasia in vivo. |
| Ji et al. 2011 [51] | China | 76 patients 145 biopsies |
48.8 | n/a 86.2 |
n/a 97.4 |
n/a 89.3 |
n/a 96.6 |
n/a 92.8 |
CLE is useful for identifying gastric metaplasia. These findings could have potential applicability for duodenal screening and suggest a possible targeting therapy in functional dyspepsia. |
| Ji et al. 2012 [52] | China | 42 patients | 50.4 | n/a | n/a | n/a | n/a | n/a | CLE allows functional imaging of mucosal barrier defects. Gastric intestinal metaplasia is associated with an impaired paracellular barrier irrespective of H. pylori eradication. |
| Lim et al. 2013 [53] | China | 20 patients 125 biopsies |
62.5 | n/a 90.9 |
n/a 84.7 |
n/a n/a |
n/a n/a |
n/a 88 |
pCLE was superior to autofluorescence imaging and white-light endoscopy for diagnosing gastric intestinal metaplasia. Off-site review improved performance of pCLE. |
| Pittayanon et al. 2013 [54] | Thailand | 60 patients 120 biopsies |
62.8 | n/a 96 |
n/a 90 |
n/a 86 |
n/a 97 |
n/a 92 |
Combining pCLE with magnifying flexible spectral imaging color enhancement (ME-FICE) provides high sensitivity and NPV for gastric intestinal metaplasia detection. The prompt histology reading by this technique may avoid unnecessary biopsy. |
| Li et al. 2014 [55] | China | 168 patients 492 biopsies |
55 | n/a 91.6 |
n/a 96.7 |
n/a n/a |
n/a n/a |
n/a n/a |
CLE with targeted biopsies is superior to white-light endoscopy with standard biopsies for the detection and surveillance of gastric intestinal metaplasia. The number of biopsies needed to confirm gastric intestinal metaplasia is about one-third of that needed with white-light endoscopy with standard biopsies. |
| Liu et al. 2015 [56] | China | 87 patients 130 biopsies |
49.7 | n/a 91.9 |
n/a 96.8 |
n/a 90.4 |
n/a 97.3 |
n/a 95.6 |
CLE is reliable for real-time assessment of atrophic gastritis and is also able to differentiate metaplastic from nonmetaplastic atrophy. |
|
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| Helicobacter pylori related gastritis | |||||||||
| Ji et al. 2010 [57] | China | 103 patients | 48.4 | 89.2 | 95.7 | 94.3 | 91.7 | 92.8 | CLE during endoscopy can accurately identify specific cellular and subcellular changes of the surface gastric mucosa induced by H. pylori infection. |
| Wang et al. 2010 [58] | China | 118 patients | 49.8 | 82.9 | 90.9 | n/a | n/a | n/a | CLE can accurately show the histological severity of H. pylori infection-associated gastritis. |
|
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| Duodenal inflammatory bowel disease | |||||||||
| Lim et al. 2014 [59] | Germany Japan UK |
25 patients | n/a | n/a | n/a | n/a | n/a | n/a | CLE can detect epithelial damage and barrier loss in the duodenum of Crohn's Disease and Ulcerative Colitis patients that is not apparent on conventional endoscopy or histology. |
|
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| Celiac disease | |||||||||
| Leong et al. 2008 [60] | Australia | 31 patients | 41 | 94 | 92 | n/a | n/a | n/a | CLE can effectively diagnose and evaluate celiac disease severity in vivo with potential to improve endoscopy efficiency. |
| Günther et al. 2010 [61] | Germany | 60 patients | 57 | 73 | 100 | n/a | n/a | n/a | The assessment of duodenal histology by CLE in patients with celiac disease is sensitive and specific in determining increased numbers of intraepithelial lymphocytes and villous atrophy but insufficient in respect of crypt hyperplasia. For routine use of CLE in patients with celiac disease, the technique would need to be improved. |
| Venkatesh et al. 2010 [62] | UK | 19 patients | 8.35 | 100 | 80 | 81 | n/a | n/a | CEL offers the prospect of diagnosis of celiac disease during ongoing endoscopy. It also enables targeting biopsies to abnormal mucosa and thereby increasing the diagnostic yield, especially when villous atrophy is patchy in the duodenum. |
N stands for the number of patients enrolled in the study; n/a, not available or not applicable; pCLE, probe-based confocal laser endomicroscopy; CLE, confocal laser endomicroscopy; PPV, positive predictive value; NPV, negative predictive value; and BE, Barrett's esophagus.