Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrhosis

Summary

This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is compared, and it will be performed within 48 hours after ds-MCE examination. The primary outcome is the sensitivity and specificity of ds-MCE in identifying the presence of esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference. The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction assessment and safety evaluation will also be evaluated.

Conditions

• Liver Cirrhosis
• Portal Hypertension
• Esophageal Varices
• Gastric Varix

Interventions

DIAGNOSTIC_TEST

ds-MCE and EGD

Procedure of ds-MCE: The ds-MCE system mainly consists of two parts: the NaviCam magnetically maneuvered capsule endoscopy system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. After completing the esophageal examination, the capsule could be detached from the string through injecting air into the hollow string with the syringe. Then, the examination of stomach under magnetic control and small bowel under the natural action of gastrointestinal peristalsis follows. Procedure of EGD: The esophagogastroduodenoscopy (EGD) will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session.

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• Shanghai Tongji Hospital, Tongji University School of Medicine

  collaborator OTHER

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  collaborator OTHER

• Shanghai East Hospital of Tongji University

  collaborator OTHER

• Yangpu District Central Hospital Affiliated to Tongji University

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• The Fifth Affiliated Hospital of Zunyi Medical College

  collaborator OTHER

• The First Affiliated Hospital of Zhejiang Chinese Medical University

  collaborator OTHER

• Shanghai Pudong New Area Gongli Hospital

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zhuan Liao · Changhai Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-07

Primary Completion

2023-01-10

Completion

2023-03-06

Countries

• China

Study Locations