NCT04720521

Application of OE in Diagnosis of EGC

Application of OpticalEnhancement Endoscopy（OE） in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,454 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentiating the diagnosis of neoplastic lesions of the gastric mucosa.

Detailed description

Gastric cancer is the most prevalent cancer in China，while the detection rate of early gastric cancer is lower than 10%. An effective screening method to improve the detection rate is urgently needed. Optical Enhancement (OE) mode is an endoscopic mode that uses the principle of grating for electronic staining, which provides a clear picture of the submucosal and superficial mucosal vascular structures. The OE1 mode provides enhanced images of the gastric Gland tube and blood vessels, as well as magnification. The OE2 mode is used to identify small chromatic aberrations and to visualize superficial structures in the gastric mucosa. So we designed this randomized controlled trial to discuss effectiveness of OE in the diagnosis of early gastric cancer and we hope to find an effective method to improve the detection rate of early gastric cancer in China.

Conditions

• High Risk Population of Gastric Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	OE+white light	Firstly use white light to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus

Timeline

• Start date: 2019-05-10
• Primary completion: 2021-03-10
• Completion: 2021-05-10
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: China