NCT04984863

MCCE in Assessing Efficacy of Gastro-oesophageal Varices

Clinical Usefulness of Magnetically Controlled Capsule Endoscopy in Assessing Efficacy of Gastro-oesophageal Varices in Patients With Liver Cirrhosis Treated Under Gastroscopy: a Prospective, Multicenter Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.

Detailed description

Gastro-esophageal varices is one of the complications of portal hypertension in cirrhosis. For patients with moderate to severe varicose veins, international guidelines recommend active treatment, including endoscopic therapy such as endoscopic band ligation (EBL) and interventional radiotherapy such as balloon-occluded retrograde transvenous obliteration (B-RTO)Electronic gastroscopy is the gold standard for the diagnosis of varicose veins at higher blood risk (varicose veins requiring retreatment). However, it is relatively invasive and uncomfortable in the examination process, so that patients with gain-and-compensation cirrhosis are often unwilling to accept it, which is not conducive to the standardized follow-up after the treatment of gastro-esophageal varices.Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa. Patients only need to swallow a capsule endoscope to make repeated observation for many times, and the examination process is painless. It is an ideal method for diagnosing varicose veins with high blood risk (varicose veins that need treatment). Therefore, this study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.

Conditions

• Gastroesophageal Varices

Interventions

Type	Name	Description
DEVICE	Magnetically controlled capsule endoscopy	Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-01-30
• Completion: 2022-06-30
• First posted: 2021-08-02
• Last updated: 2021-08-02

Locations

1 site across 1 country: China