An interventional study of ds-MCE and EGD in Liver Cirrhosis, Portal Hypertension and Esophageal Varices, sponsored by Changhai Hospital. Completed at 14 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Diagnostic
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.
Cirrhosis is the major cause of liver disease-related morbidity and mortality worldwide. Portal hypertension (PH) is the hemodynamic abnormality in patients with cirrhosis, which is associated with various pathological changes throughout the entire gastrointestinal tract, manifesting as esophagogastric varices (EGV), portal hypertensive gastropathy (PHG), and portal hypertensive enteropathy (PHE). Baveno consensus and other practice guidelines recommended that patients with cirrhosis undergo endoscopic screening for EGV at the time of diagnosis and undergo periodic surveillance endoscopy throughout the whole course of cirrhosis.
Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and follow-up of EGV in cirrhotic patients, allowing for direct mucosal visualization and therapeutic intervention. EGD is however an invasive procedure and there is potential for procedure-related complications, such as perforation and bleeding. Besides, conscious sedation is always required, leading to increased cost, risk, and inconvenience for the patients.These factors lead to a decrease of patient compliance as well as the effectiveness of the screening program.
The capsule endoscopy (CE) system provides a noninvasive and relatively comfortable approach to visualize the GI tract, and the development of esophageal capsule endoscopy (ECE) makes it possible to capture clear images of esophagus without the need of sedation. However, the accuracy of ECE is not currently sufficient to replace EGD for the detection and grading for the esophageal varices. Besides, previous studies presented that the sensitivity of ECE for detecting gastric varices (GVs) and PHG varies from 3% to 69%, which denoted ECE was far from a suitable alternative for diagnosing gastric lesions.
To overcome these limitations, a new technique, so-called detachable string magnetically maneuvered capsule endoscopy (ds-MCE) was developed. The ds-MCE system consists of two parts: the magnetically maneuvered capsule endoscopy (MCE) system and a transparent latex sleeve with a hollow string. One end of the hollow string is a transparent thin latex sleeve that can be wrapped on the surface of the capsule, and the other end of the string is connected to the syringe. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. In this case, investigator can examine the entire esophageal mucosa several times under real time views. The capsule then can be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. The magnetic capsule in the stomach can be accurately controlled through multidimensional rotation and adaptive matching of an external C-arm robot. Previous studies have demonstrated that the diagnostic accuracy of MCE for detecting gastric focal lesions is comparable with that of conventional EGD. Two previously studies of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life of the ds-MCE enables complete examination of the small bowel, which enables to provide a more comprehensive evaluation of gastrointestinal changes.
Considering all these backgrounds, in the current prospective study, the primary aim is to assess the diagnostic performance of the ds-MCE in identifying the presence of EGV in cirrhotic patients, using EGD as the reference standard. 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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 607 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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Exclusion Criteria:
All the enrolled participants will undergo the examination of detachable string magnetically maneuvered capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.
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.
the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV)
the sensitivity and specificity of ds-MCE in identifying EGV in patients with cirrhosis, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in identifying the presence of esophageal varices (EV)
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of EV, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in identifying the red sign of EV
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in identifying the red sign of EV, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in differentiating large esophageal varices
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of large EV, using the detection by EGD as the reference.
Time frame: 2 weeks
the optimal esophageal luminal circumference percentage threshold under ds-MCE for distinguishing large EV
To investigate the optimal threshold of the proportion of ds-MCE esophageal luminal circumference occupied by the largest esophageal varix present in differentiating large EV from small or no EV, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in differentiating high-risk esophageal varices
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EV, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in detection of high-risk EGV
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EGV, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in detecting gastric varices (GV)
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of GV, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in detecting cardiofundal gastric varices
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of cardiofundal GV, using the detection by EGD as the reference.
Time frame: 2 weeks
the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy
The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of portal hypertensive gastropathy (PHG), using the detection by EGD as the reference.
Time frame: 2 weeks
the incidence of portal hypertensive enteropathy (PHE) under ds-MCE
Endoscopic findings of PHE include mucosal inflammatory-like abnormalities, vascular lesions and spontaneous bleeding.
Time frame: 2 weeks
the examination time of ds-MCE and EGD
Examination time of ds-MCE include esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), small bowel transit time (SBTT), and total running time (TRT). Examination time of EGD is the time from the endoscope entering to exiting from the esophagus.
Time frame: 2 weeks
patient satisfaction evaluation of the ds-MCE and EGD
Patient satisfaction score of ds-MCE and EGD procedures.
Time frame: 2 weeks
Safety evaluation
All adverse events occurring during the study will be recorded.
Time frame: 2 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data can be shared after publication of the main results.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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