Results from a randomised controlled trial in Endoscopy show a novel confocal laser endomicroscopy (CLE) platform called Cellvizio doubled the diagnostic yield of patients with half the required biopsies.

The new data builds on a recently published meta-analysis of Cellvizio in stomach cancer and further establishes the superiority of biopsies guides by a combination of endoscopic imaging with Flexible spectral Imaging Colour Enhancement (FICE) and probe-based confocal laser endomicroscopy (pCLE) with Cellvizio, compared to standard FICE without pCLE for in vivo detection of pre-cancerous and cancerous gastric lesions.

According to JAMA Oncology, the annual incident rate of stomach cancer exceeds 1.3 million cases worldwide, making it the 3rd most common malignancy globally by incidence and mortality (after cancers of the lung and the breast).

An estimated 1 in 27 men and 1 in 68 women will develop stomach cancer before the age of 79 years.

Led by principal investigator Pr. Yan-Qing Li, Chief physician and Vice President of Qilu hospital of Shandong University, this key study enrolled 238 patients who were randomized in two groups (FICE-guided pCLE with targeted biopsies (using a Gastroflex UHD Confocal Miniprobe) or FICE with standard biopsies) at four clinical institutions in China.

The diagnostic yield of gastric intestinal metaplasia (GIM), gastric intraepithelial neoplasia (GIN), and early gastric cancer (EGC) was compared between the two groups as a main outcome.

Secondary outcomes include the number of necessary biopsies to achieve diagnosis and time taken for the procedure.

On a per-biopsy analysis, FICE-guided pCLE with targeted biopsies more than doubled the diagnostic yield of GIM/GIN/EGC vs. FICE with standard biopsies, from 31.5% to 75.1% (p< 0.001).

FICE-guided pCLE with targeted biopsies led to a 48.5% decrease in the number of biopsies per patient vs. FICE with standard biopsies (p<0.001).

Procedure time was not significantly different between the 2 groups (17 minutes in the pCLE group vs. 16 minutes in the control group).

Sensitivity, specificity, positive predictive value and negative predictive value of pCLE were 87.5%, 98%, 87.5% and 98% for GIN and 95%, 94.6%, 90.5% and 97.5% for GIM.

The authors concluded, “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 versus FICE with standard biopsies. This may allow for a better regimen for endoscopic surveillance and subsequent treatment of patients with premalignant and malignant gastric abnormalities. All pCLE procedures were performed safely and successfully in participating patients.”

Source: BusinessWire