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Endoscopy 2017; 49(11): 1033-1042
DOI: 10.1055/s-0043-115382
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Probe-based endomicroscopy for in vivo detection of gastric intestinal metaplasia and neoplasia: a multicenter randomized controlled trial

Xiu-Li Zuo   *
1   Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China
,
Zhen Li   *
1   Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China
,
Chang-Qing Li
1   Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China
,
You-You Zheng
1   Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China
,
Li-Dong Xu
1   Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China
,
Jie Chen
2   Department of Gastroenterology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
,
Rong Lin
2   Department of Gastroenterology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
,
Jun Song
2   Department of Gastroenterology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
,
Chao-Hui Yu
3   Department of Gastroenterology, First Affiliated Hospital of College of Medicine, Zhejiang University, Zhejiang, China
,
Min Yue
3   Department of Gastroenterology, First Affiliated Hospital of College of Medicine, Zhejiang University, Zhejiang, China
,
Qi Zhou
4   Department of Gastroenterology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
,
Zhi-Yan Liu
5   Department of Pathology and Pathophysiology, Shandong University School of Medicine, Jinan, China
,
Yan-Qing Li
1   Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China
› Author Affiliations
Further Information

Publication History

submitted 04 December 2016

accepted after revision 14 May 2017

Publication Date:
28 July 2017 (online)

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Abstract

Background and study aims Owing to the indistinctive endoscopic appearance of gastric intestinal metaplasia (GIM), gastric intraepithelial neoplasia (GIN), and early gastric cancer (EGC), a significant number of such lesions may be missed during surveillance endoscopy. The aim of this clinical trial was to assess the value of combined computed virtual chromoendoscopy (flexible spectral imaging color enhancement [FICE]) and probe-based confocal laser endomicroscopy (pCLE) for in vivo detection of GIM, GIN, and EGC.

Patients and methods This was a multicenter, randomized controlled trial performed in 238 patients at four tertiary centers. Patients were randomized to FICE-guided pCLE with targeted biopsies (group A) or FICE with standard biopsies (group B). The diagnostic yield of GIM, GIN, or EGC was compared between the two groups.

Results On a per-patient assessment, the diagnostic yield for GIM/GIN/EGC was 73.3 % (88/120) in group A and 63.6 % (75/118) in group B (P = 0.09). On a per-biopsy analysis, FICE-guided pCLE with targeted biopsies significantly increased the diagnostic yield of GIM/GIN/EGC vs. FICE with standard biopsies, from 31.5 % (252/800) to 75.1 % (313/417) (P < 0.001). In addition, pCLE-guided targeted biopsies led to a significant 48.5 % decrease in the number of biopsies per patient vs. FICE with standard biopsies (P < 0.001).

Conclusions Real-time pCLE and targeted biopsies after FICE improved the diagnostic yield for the detection of GIM, GIN, and EGC, and only required about half the number of biopsies vs. FICE with standard biopsies. This may allow a better regimen for endoscopic surveillance and subsequent treatment of patients with premalignant and malignant gastric abnormalities.

Trial registered at ClinicalTrials.gov (NCT02515721).

* These authors contributed equally to this work.


 

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