CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 607 enrolled
Drug / intervention
ds-MCE and EGDother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03748563
NCT03748563N/ACompleted
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Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of Esophagogastric Varices in Patients With Cirrhosis

Changhai Hospital·interventional·Posted Nov 21, 2018·Updated Aug 1, 2023

In Brief

A clinical study evaluating ds-MCE and EGD for Liver Cirrhosis and 3 related conditions. Completed, enrolled 607 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cirrhosis, Portal Hypertension, Esophageal Varices, Gastric Varix
CountriesChina
CollaboratorsRuijin Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai East Hospital of Tongji University, Yangpu District Central Hospital Affiliated to Tongji University, Zhujiang Hospital, Qilu Hospital of Shandong University, The Third Xiangya Hospital of Central South University, First Affiliated Hospital Xi'an Jiaotong University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Fifth Affiliated Hospital of Zunyi Medical College, The First Affiliated Hospital of Zhejiang Chinese Medical University, Shanghai Pudong New Area Gongli Hospital

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 21, 2018
Enrollment StartJan 7, 2021
Primary CompletionJan 10, 2023
Study CompletionMar 6, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.6 years ago

Interventions

ds-MCE and EGDother

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.